Federal Register Vol. 82, No.237,

Since the founding of the nation, the U.S. Census has mediated between the demands of a growing country for information about its economy and people, and the people's privacy and respondent burden. Beginning with the 1810 Census, Congress added questions to support a range of public concerns and uses, and over the course of a century questions were added about agriculture, industry, and commerce, as well as occupation, ancestry, marital status, disabilities, and other topics. In 1940, the U.S. Census Bureau introduced the long form and, since then, the more detailed questions were only asked of a sample of the public.

The American Community Survey (ACS), launched in 2005, is the current embodiment of the long form of the census and is asked each year of a sample of the U.S. population in order to provide current data needed more often than once every ten years.

The content of the proposed 2019 ACS questionnaire and data collection instruments for both Housing Unit and Group Quarters operations reflects changes to content and instructions that were proposed as a result of the 2016 ACS Content Test. The Census Bureau periodically conducts tests of new and improved survey content to ensure the ACS is meeting the data needs of its stakeholders. The primary objective of content tests is to test whether changes to question wording, response categories, and definitions of underlying constructs improve the quality of data collected.

The ACS is one of the Department of Commerce's most valuable data products, used extensively by businesses, non-governmental organizations (NGOs), local governments, and many federal agencies. In conducting this survey, the Census Bureau's top priority is respecting the time and privacy of the people providing information while preserving the survey's value to the public. The 2019 survey content changes cover several topics:

The rise of cellphone and smartphone usage, and other complex and varied telephone services and equipment, has changed how people view and use telephones in a household. Research also suggests that some respondents, or in some cases interviewers, may not fully understand the current wording of the survey question on Telephone Service, the additional instructions that accompany the question, or what the question is intending to capture. To make the intent of the Telephone Service question easier to understand by respondents and interviewers, the question was made a stand-alone question and additional instructions are provided on the types of telephones and equipment respondents should include when answering the question. Currently, telephone service is asked as part of a broader question on housing characteristics.

A question on health insurance premiums and subsidies will be introduced to the ACS immediately following the current question on health insurance coverage. The question on premiums and subsidies asks if a person pays a health insurance premium, and if so, if he or she received a subsidy to help pay the premium. This question will provide more accurate information about coverage categories than available from the existing ACS question on current coverage alone. These data will enhance the ability of HHS and the states to administer Medicaid, CHIP, and the exchanges, and monitor private insurance coverage.

Changes to the Commute Mode question were motivated by changes in public transportation infrastructure across the United States, particularly the increased prevalence of light rail systems and the need to update and clarify the terminology used to refer to commute modes that appear as categories on the ACS. To improve the Commute Mode question, some of the public transportation modes were modified. The category “Streetcar or trolley car” was changed to “Light rail, street car, or trolley,” “Subway or elevated” was changed to “Subway or Elevated Rail,” and “Railroad” was changed to “Long-distance train or commuter rail.” These three rail-related categories were also slightly reordered so that “Subway or elevated rail,” the most prevalent rail mode, is listed first. The phrase “trolley bus” was dropped and the phrase “work at home” was changed to “work from home.” The subheading of instructions was simplified to read “Mark ONE box for the method of transportation used for most of the distance.” The Time of Departure question has historically raised concerns about privacy because of the reference to the time a person leaves home. To phrase the question in a less intrusive way, the question was changed to ask what time the person's trip to work began and to remove the word “home.”

The changes to the question on the number of weeks worked were made to allow the Census Bureau to provide high-quality, continuous measures for the number of weeks worked, such as means, medians, and aggregates. In addition, the changes enable additional specificity for weeks worked, particularly with hours worked, income, and occupation. Part A of the question regarding the time period of interest was rephrased from working “50 or more weeks” to “EVERY week” and additional information is provided in the second sentence. The original instruction of “Count paid time off as work” was changed to “Count paid vacation, paid sick leave, and military service as work.” For part B of the question, the response option was changed to a write-in response, the reference period (“the PAST 12 MONTHS”) is repeated, and new guidance clarifies what to count as work.

Changes to the Class of Worker question improve overall question clarity, refine the definition of unpaid family workers, explicitly define a category for Active Duty military, improve question wording and categories, and improve the layout of the question. Response categories were grouped under three general headings. “Active Duty” was added as one of the response categories in the government section, and the “Active Duty” checkbox was dropped from the Employer Name question. Question and response category wording were revised for clarity. To signal that all six employment characteristics questions refer to the same job (including industry and occupation), the series was renumbered from separate questions to a single series with sub-questions. Lastly, the instructional text and heading for the series immediately preceding the Class of Worker question was simplified.

Ongoing research of the Industry and Occupation question write-in responses has demonstrated that the questions were unclear and confusing to respondents, who were unable to answer at all or answer with sufficient clarity to provide useful data. To increase clarity and improve occupational specificity, these questions were revised to include new and consistent examples, in terms of content and length, and include modified question wording. The number of characters for write-in responses about “Job Duties” was expanded from 60 to 100 characters.

Over the last 40 years, defined contribution retirement plans have become increasingly common while defined benefit plans (such as pensions) have become less so. Federal surveys have lagged in addressing these newer forms of retirement income and subsequently underreport retirement income. The Retirement, Survivor, and Disability Income question was changed to improve income reporting, increase item response rates, reduce reporting errors, and update questions on retirement income and the income generated from retirement accounts and all other assets in order to better measure retirement income data. The question was expanded to ask about “retirement income, pensions, survivor or disability income.” In addition, the instructions that accompany the question were expanded to note that income from “a previous employer or union, or any regular withdrawals or distributions from IRA, Roth IRA, 401(k), 403(b) or other accounts specifically designed for retirement” should be included.

For several years, the Census Bureau has been testing revised Relationship questions to improve the estimates of coupled households. The 1990 Census first introduced “Unmarried Partner” as a response category to the Relationship to Householder question. The 2000 and 2010 Censuses built upon this work, changing the processing of responses to the Relationship question to more accurately represent same-sex couples. The Census Bureau discovered a statistical error in the 2010 Census data that resulted from opposite-sex couples mismarking their sex. This error has the potential to inflate the estimates of same-sex, married-couple households from the 2010 Census. The Census Bureau released a set of modified state-level, same-sex household estimates from the 2010 Census because of this error, and also began new research efforts to improve the Relationship question.

The Relationship question has been revised to improve measurement of same-sex couples. The existing “Husband or wife” and “Unmarried partner” response categories were each split into two versions: “Opposite-sex husband/wife/spouse,” “Opposite-sex unmarried partner,” “Same-sex husband/wife/spouse,” and “Same-sex unmarried partner.” Additionally, the two unmarried partner categories were moved from near the end of the list of response options to near the beginning, immediately after the “Husband/wife/spouse” options. An automated relationship/sex consistency check will be included in electronic instruments to provide respondents an opportunity to change their sex or relationship responses when there is an inconsistency in the reported sex of an individual and whether their relationship was reported as “Opposite-sex” or “Same-sex” husband/wife/spouse or unmarried partner. This check reduces the inconsistency in responses for a given household and improves the quality of the relationship data. The category “Roomer or boarder” has been dropped from the Relationship question.

The 2016 ACS Content Test served as an operational test of the race and ethnicity questions that were previously tested on the 2015 National Content Test (NCT). While recommendations about the race and ethnicity questions adopted for the 2020 Census and production ACS will be based on the results of the census tests and decisions made in consultation with the Office of Management and Budget (OMB), the 2016 ACS Content Test provided an opportunity to test data collection modes and examine other data not available in the 2015 NCT. The 2016 ACS Content Test evaluated interviewer-administered collection modes, assessed the race and ethnicity questions against demographic and socioeconomic data, and separately compared the race and ethnicity results to data from the ancestry question. In 2020 or later, the ACS will adopt the final version of the race and Hispanic origin questions that are implemented for the 2020 Census.

In August 2012, the OMB in conjunction with the Census Bureau established a Subcommittee of the Interagency Council on Statistical Policy (ICSP) to address ACS matters. The ICSP Subcommittee on the ACS exists to advise the Chief Statistician at OMB and the Director of the Census Bureau on how the ACS can best fulfill its role in the portfolio of Federal household surveys and provide the most useful information with the least amount of burden. It may also advise Census Bureau technical staff on issues they request the subcommittee to examine or that otherwise arise in discussions. The ICSP Subcommittee on the ACS reviewed the proposed 2019 ACS content changes and recommended their approval to the OMB and the Census Bureau. For the 2016 ACS Content Test, initial versions of the new and revised questions were proposed by federal agencies participating in the OMB Interagency Committee for the ACS. The initial proposals contained a justification for each change and described any previous testing of the question wording, the expected impact of revisions to the time series and the single-year as well as five-year estimates, and the estimated net impact on respondent burden for the proposed revision. For proposed new questions, the justification also described the need for the new data, whether federal law or regulation required the data for small areas or small population groups, if other data sources were currently available to provide the information (and why any alternate sources were insufficient), how policy needs or emerging data needs would be addressed through the new question, an explanation of why the data were needed with the geographic precision and frequency provided by the ACS, and whether other testing or production surveys had evaluated the use of the proposed questions.

The Census Bureau and the OMB, as well as the ICSP Subcommittee, reviewed these proposals for the ACS. The OMB determined which proposals moved forward into cognitive testing. After OMB approval of the proposals, topical subcommittees were formed from the OMB Interagency Committee on the ACS, which included all interested federal agencies that use the data from the proposed questions. These subcommittees further refined the specific proposed wording in preparation for cognitive testing.

The Census Bureau contracted with Westat, an internationally recognized organization with expertise in statistical research and survey methods, to conduct three rounds of cognitive testing. The results of the first two rounds of cognitive testing informed decisions on specific revisions to the proposed content for the stateside 2016 ACS Content Test. The proposed changes, identified through cognitive testing for each question topic, were reviewed by the Census Bureau, the corresponding topical subcommittee, and the ICSP Subcommittee for the ACS. The OMB then provided final overall approval of the proposed wording for field testing.

The public is invited to comment on all questions on the ACS; however, the Census Bureau is particularly interested in comments on the wording changes to the nine ACS questions listed above, which are proposed to be changed based on the results of the 2016 ACS Content Test. Concurrently, Federal agencies that are the principal sponsors of these nine questions are invited to respond either directly to the Census Bureau or through this notice.

OMB Control Number: 0607-0810.

Form Number(s): ACS-1(2019).

Type of Review: Regular submission.

Affected Public: Federal and legislative agencies, individuals, households, and businesses.

Estimated Time per Response: 40 minutes for the average household questionnaire.

Estimated Total Annual Burden Hours: The Census Bureau plans to contact the following number of respondents each year: 3,540,000 households; 200,000 persons in group quarters; 20,000 contacts in group quarters; 43,000 households for reinterview; and 1,500 group quarters contacts for reinterview. The estimate is an annual average of 2,337,900 burden hours.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Mandatory.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Appendix I, DoD Pilot Mentor-Protege Program; OMB Control Number 0704-0332.

Type of Request: Reinstatement with change.

Number of Respondents: 122.

Responses per Respondent: Approximately 2.

Annual Responses: 240.

Average Burden per Response: 1 hour.

Annual Response Burden Hours: 240.

Reporting Frequency: Two times per year for mentor firms; one time per year for protege firms.

Needs and Uses: DoD needs this information to ensure that participants in the Mentor-Protege Program (“the Program”) are fulfilling their obligations under the mentor-protege agreements and that the Government is receiving value for the benefits it provides through the Program. DoD uses the information as source data for reports to Congress required by section 811(d) of the National Defense Authorization Act for Fiscal Year 2000 (Pub. L. 106-65). Participation in the Program is voluntary.

Affected Public: Businesses and other for-profit entities and not-for-profit institutions.

Respondent's Obligation: Required to obtain or retain benefits.

OMB Desk Officer: Ms. Jasmeet Seehra.

Written comments and recommendations on the proposed information collection should be sent to Ms. Seehra at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.

You may also submit comments, identified by docket number and title, by the following method: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, docket number, and title for the Federal Register document. The general policy for comments and other public submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information provided. To confirm receipt of your comment(s), please check http://www.regulations.gov approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

DoD Clearance Officer: Mr. Frederick C. Licari. Written requests for copies of the information collection proposal should be sent to Mr. Licari at: Information Collections Program, WHS/ESD Office of Information Management, 4800 Mark Center Drive, 3rd Floor, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

The document is available at the following locations: (1) Elizabeth River and Southern Branch Navigation Improvements website: http://www.nao.usace.army.mil/About/Projects/ElizabethRiverSouthernBranchNav.aspx, (2) Slover Public Library, 235 East Plume Street, Norfolk, VA 23510. (3) Copies may also be requested in writing at (see ADDRESSES).

Proposed Action. The Study Area is located in Hampton Roads, a 25 square-mile natural harbor serving port facilities in the cities of Norfolk, Newport News, Portsmouth, Chesapeake, and Hampton in southeastern Virginia. The study area consists of a of a federally improved channel extending from Lamberts Bend (on the main stem of the Elizabeth River) to the Chesapeake Extension in the southern branch of the Elizabeth River.

The Action Alternative consists of constructing and maintaining the following features:

• Deepening the channel from Lamberts Bend to Perdue Farms (Segment 1a) from a required depth of 40 feet to 45 feet deep in Segment 1a, and deepening the channel from Perdue Farms to the Norfolk Southern Lift Bridge (Segment 1b) from a required depth of 40 feet to 42 feet.

• Deepening the channel from the Norfolk Southern Lift Bridge to the Gilmerton Bridge (Segment 2), from a required depth of 35 feet to 39 feet deep; and

• Continuing to maintain the channel from the Gilmerton Bridge to the Chesapeake Extension to a required depth of 35 feet (Segment 3).

Alternatives. The Draft GRR/EA considers a reasonable range deepening alternatives in the project channels to meet the proposed action's purpose and need. It also incorporates measures to avoid and minimize impacts to threatened and endangered species, fish and wildlife species, estuarine and marine habitat, and other resources. In response to problems and opportunities, a range of alternatives was evaluated through an iterative screening and formulation process, resulting in identification of a Preferred Alternative.

Public Involvement. On September 22, 2015, a Notice of Intent to publish an EA was published, along with information on a NEPA public scoping meeting on September 24, 2015. A Federal Register Notice was also published to announce the initiation of the feasibility study and also the public NEPA scoping meeting. As part of the public involvement process, all affected federal, Commonwealth of Virginia, and local agencies, private organizations, and the public were invited to the Public Scoping Meeting on September 24, 2015 in Norfolk, Virginia.

This study is authorized under Section 216 of the Flood Control Act of 1970 (Pub. L. 91-611), which authorizes the review of completed projects in the interest of navigation and related purposes to determine the feasibility of further port deepening.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Evaluation of the ESEA Title VI Indian Education LEA Grants Program.

OMB Control Number: 1875—NEW.

Type of Review: A new information collection.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 434.

Total Estimated Number of Annual Burden Hours: 295.

Abstract: This data collection request supports a national evaluation of the Title VI Grants Program that will describe how grantees identify eligible children, and plan and implement program priorities with parent, community and tribal involvement; help AI/AN students meet state standards; align and leverage program funded services with other resources; and assess student outcomes. This information will inform the U.S. Department of Education's Office of Indian Education (OIE), other federal policy, budget and program staff, and grantees about the implementation of current practices. To gather consistent information that addresses questions about how Title VI grantees are identifying eligible children and planning and implementing services for them, it is necessary to collect additional information beyond current federal data collections (e.g., Annual Performance Reports and EASIE Budget Reports provided by the OIE).

Section 743 of Division C of the Consolidated Appropriations Act of 2010, Public Law 111-117, requires civilian agencies, other than the Department of Defense, that are required to submit an inventory in accordance with the Federal Activities Inventory Reform Act of 1998 (Pub. L. 105-270, 31 U.S.C. 501 note) to submit their inventories to the Office of Federal Procurement Policy in the Office of Management and Budget by December 31, 2016. In addition, section 743 requires these agencies, which include the Department of Education, to (1) make the inventory available to the public, and (2) publish in the Federal Register a notice announcing that the inventory is available to the public along with the name, telephone number, and email address of an agency point of contact.

Through this notice, the Department announces the availability of its inventory on the following website: http://www2.ed.gov/fund/data/report/contracts/servicecontractinventoryappendix/servicecontractinventory.html. The point of contact for the inventory is provided under FOR FURTHER INFORMATION CONTACT.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., Braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Program Authority: Section 743 of Division C of the Consolidated Appropriations Act of 2010, Public Law 111-117.

Purpose of the Committee: The Hydrogen and Fuel Cell Technical Advisory Committee (HTAC) was established under section 807 of the Energy Policy Act of 2005 (EPACT), Public Law 109-58; 119 Stat. 849, to provide advice and recommendations to the Secretary of Energy on the program authorized by Title VIII of EPACT.

Tentative Agenda: (updates will be posted on the web at): http://hydrogen.energy.gov/advisory_htac.html).

Public Participation: The meeting is open to the public. Individuals who would like to attend and/or to make oral statements during the public comment period must register no later than 5:00 p.m. on Monday, February 5, 2018, by email at [email protected]. Entry to the meeting room will be restricted to those who have confirmed their attendance in advance. Please provide your name, organization, citizenship, and contact information. Anyone attending the meeting will be required to present government-issued identification. Those wishing to make a public comment are required to register. The public comment period will take place between 8:30 a.m. and 8:45 a.m. on February 13, 2018. Time allotted per speaker will depend on the number who wish to speak but will not exceed five minutes. Those not able to attend the meeting or have insufficient time to address the committee are invited to send a written statement to [email protected].

Minutes: The minutes of the meeting will be available for public review at http://hydrogen.energy.gov/advisory_htac.html.

As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control No.: 3060-1054.

Title: Application for Renewal of an International Broadcast Station License.

Form No.: FCC Form 422-IB.

Type of Review: Extension of a currently approved information collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 10 respondents; 50 responses.

Estimated Time per Response: 1-8 hours per response.

Frequency of Response: On occasion reporting requirement; Recordkeeping requirement.

Obligation To Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 154, 303, 334, 336 and 339.

Total Annual Burden: 160 hours.

Annual Cost Burden: $36,000.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information.

Needs and Uses: This collection will be submitted to the Office of Management and Budget (OMB) as an extension following the 60-day comment period in order to obtain the full three-year clearance from OMB.

The Federal Communications Commission (“Commission”) plans to implement and release to the public an “Application for Renewal of an International Broadcast Station License (FCC Form 422-IB).” The form has not been implemented yet due to a lack of budget resources and technical staff. After the FCC Form 422-IB has been implemented and the Commission receives final approval from OMB, applicants will complete the FCC Form 422-IB in lieu of the “Application for Renewal of an International or Experimental Broadcast Station License,” (FCC Form 311). In the interim, applicants will continue to file the FCC Form 311 with the Commission. (Note: The OMB approved the FCC Form 311 under OMB Control No. 3060-1035).

The Commission stated previously that the FCC Form 422-IB will be available to applicants in the International Bureau Filing System (“IBFS”) after it is implemented. However, the Commission plans to develop a new licensing system within the next five years that will replace IBFS. Therefore, the FCC Form 422-IB will be made available to the public in CLS instead of IBFS.

The information collected pursuant to the rules set forth in 47 CFR part 73, subpart F, is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations and to determine if interference or adverse propagation conditions exist that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-0329.

Title: Section 2.955, Equipment Authorization—Verification (Retention of Records).

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit and not-for-profit institutions.

Number of Respondents and Responses: 8,000 respondents; 8,000 responses.

Estimated Time per Response: 18 hours (average).

Frequency of Response: One-time and on occasion reporting requirements, recordkeeping requirement; and third-party disclosure requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. Sections 4(i), 302, 303(g), and 303(r) of the Communications Act of 1934, as amended; 47 U.S.C. 154(i), 302 and 303(r).

Total Annual Burden: 144,000 hours.

Total Annual Cost: $1,600,000.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Commission rules require equipment testing to determine performance and compliance with FCC standards. This testing is typically done by either the manufacturer's testing laboratory or an independent testing laboratory.

Needs and Uses: This collection will be submitted as an extension after this 60-day comment period to the Office of Management and Budget (OMB) in order to obtain the full three-year clearance.

Section 2.955 describes for each equipment device subject to verification, the responsible party, as shown in 47 CFR 2.909 shall maintain the records listed as follows:

(1) A record of the original design drawings and specifications and all changes that have been made that may affect compliance with the requirements of § 2.953.

(2) A record of the procedures used for production inspection and testing (if tests were performed) to insure the conformance required by § 2.953. (Statistical production line emission testing is not required.)

(3) A record of the measurements made on an appropriate test site that demonstrates compliance with the applicable regulations in this chapter. The record shall:

(i) Indicate the actual date all testing was performed;

(ii) State the name of the test laboratory, company, or individual performing the verification testing. The Commission may request additional information regarding the test site, the test equipment or the qualifications of the company or individual performing the verification tests;

(iii) Contain a description of how the device was actually tested, identifying the measurement procedure and test equipment that was used;

(iv) Contain a description of the equipment under test (EUT) and support equipment connected to, or installed within, the EUT;

(v) Identify the EUT and support equipment by trade name and model number and, if appropriate, by FCC Identifier and serial number;

(vi) Indicate the types and lengths of connecting cables used and how they were arranged or moved during testing;

(vii) Contain at least two drawings or photographs showing the test set-up for the highest line conducted emission and showing the test set-up for the highest radiated emission. These drawings or photographs must show enough detail to confirm other information contained in the test report. Any photographs used must be focused originals without glare or dark spots and must clearly show the test configuration used;

(viii) List all modifications, if any, made to the EUT by the testing company or individual to achieve compliance with the regulations in this chapter;

(ix) Include all of the data required to show compliance with the appropriate regulations in this chapter; and

(x) Contain, on the test report, the signature of the individual responsible for testing the product along with the name and signature of an official of the responsible party, as designated in § 2.909.

(4) For equipment subject to the provisions in part 15 of this chapter, the records shall indicate if the equipment was verified pursuant to the transition provisions contained in § 15.37 of this chapter.

(b) The records listed in paragraph (a) of this section shall be retained for two years after the manufacture of said equipment item has been permanently discontinued, or until the conclusion of an investigation or a proceeding if the manufacturer or importer is officially notified that an investigation or any other administrative proceeding involving his equipment has been instituted.

The Commission needs and requires the information under FCC Rules at 47 CFR parts 15 and 18, that RF equipment manufacturers (respondents) `self-determine” their responsibility for adherence to these rules, as guided by the following criteria:

(a) Whether the RF equipment device that is being marketed complies with the applicable Commission Rules; and

(b) If the operation of the equipment is consistent with the initially documented test results, as reported to the Commission.

The information collection is essential to controlling potential interference to radio communications.

(a) Companies that manufacture RF equipment are the anticipated respondents to this information collection.

(b) This respondent “public” generally remains the same, although the types of equipment devices that they manufacture may change in response to changing technologies and to new spectrum allocations made by the Commission.

(c) In addition, the Commission may establish new technical operating standards in response to these changing technologies and in allocation spectrum, which these RF equipment manufacturers must meet to receive their equipment authorization from the FCC.

(d) However, the process that RF equipment manufacturers must follow to verify their compliance, as mandated by 47 CFR 2.955 of FCC Rules, will not change despite new technical standards established for specific equipment.

This information collection, therefore, applies to a variety of equipment, which is currently manufactured in the future, and that operates under varying technical standards.

OMB Control Number: 3060-1116.

Title: Submarine Cable Reporting.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit, not-for-profit institutions.

Number of Respondents and Responses: 63 respondents; 63 responses.

Estimated Time per Response: 190 hours.

Frequency of Response: On occasion and annual reporting requirements.

Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 303(r) and 403.

Total Annual Burden: 11,970 hours.

Total Annual Cost: No Cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Information provided pursuant to this request will be viewed as presumptively confidential upon submission because the information would reflect reports on weaknesses in or damage to national communications infrastructure, and the release of this sensitive information to the public could potentially facilitate terrorist targeting of critical infrastructure and key resources. The submissions also may contain internal confidential information that constitutes trade secrets and commercial/financial information that the respondent does not routinely make public and public release of the submitted information could cause competitive harm by revealing information about the types and deployment of cable equipment and the traffic that flows across the system. For these reasons, the information requested in (b) (Terrestrial Route Map) and (c) (Undersea Location Spreadsheet) above is presumptively exempt from public disclosure under Freedom of Information Act (FOIA) Exemption 3, 5 U.S.C. 552(b)(3), and section 4(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(j), as implemented in 47 CFR 0.457(c)(1)(i) (exempting disclosure of “maps showing the exact location of submarine cables”). The information requested in (a) (System Status and Restoration Messages) and (d) (Restoration Capability) described above will be considered exempt under Exemption 4 of the Freedom of Information Act (FOIA), 5 U.S.C. 552(b)(4). If a FOIA request is filed for information submitted in response to this request, the respondent whose records are the subject of the request will be notified of the FOIA request and given the opportunity to oppose release of the records. See 47 CFR 0.461(d)(3). We note that the information provided in response to this request will be shared with the Department of Homeland Security's National Communications System (NCS) and relevant Executive Branch agencies on a confidential basis. See 44 U.S.C. 3510.

Needs and Uses: This information is needed in order to support Federal government national security and emergency preparedness communications programs, for the purposes of providing situational awareness of submarine cable system performance as well as a greater understanding of potential physical threats to the submarine cable systems. This information will provide situational awareness regarding the operational status of submarine cable systems to the Federal government, and allow the Executive Branch to assess potential risks and threats to these critical communications systems in the context of other available information.

As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Number: 3060-0414.

Title: Terrain Shielding Policy.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities, not-for-profit institutions, State, Local or Tribal Government.

Number of Respondents and Responses: 25 respondents; 25 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 Sections 154(i) and 303 of the Communications Act of 1934, as amended.

Total Annual Burden: 25 hours.

Total Annual Cost: $56,250.

Privacy Impact Assessment(s): No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality and respondents are not being asked to submit confidential information to the Commission.

Needs and Uses: The terrain shielding policy requires respondents to submit either a detailed terrain study, or to submit letters of assent from all potentially affected parties and graphic depiction of the terrain when intervening terrain prevents a low power television applicant from interfering with other low power television or full-power television stations. FCC staff uses the data to determine if terrain shielding can provide adequate interference protection and if a waiver of 47 CFR 74.705 and 74.707 of the rules is warranted.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-1228.

Title: Connect America Fund—High Cost Portal Filing.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit, not-for-profit institutions.

Number of Respondents and Responses: 1,599 unique respondents; 3,731 responses.

Estimated Time per Response: 8 hours—60 hours.

Frequency of Response: On occasion, quarterly reporting requirements, annual reporting requirements, one-time reporting requirement and recordkeeping requirement.

Obligation To Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 410, and 1302.

Total Annual Burden: 68,607 hours.

Total Annual Cost: No Cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: We note that USAC must preserve the confidentiality of certain data obtained from respondents; must not use the data except for purposes of administering the universal service programs or other purposes specified by the Commission; and must not disclose data in company-specific form unless directed to do so by the Commission. Respondents may request materials or information submitted to the Commission or the Administrator believed confidential to be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

Needs and Uses: The Commission is requesting approval for this revised information collection. In March 2016, the Commission adopted an order reforming its universal service support program in areas served by rate-of-return carriers. Connect America Fund et al., WC Docket Nos. 10-90 et al., Report and Order, Order and Order on Reconsideration, and Further Notice of Proposed Rulemaking, FCC 16-33 (Rate-of-Return Order). In May 2016, the Commission adopted rules to implement a competitive bidding process for Phase II of the Connect America Fund. Connect America Fund et al., WC Docket Nos. 10-90 et al., Report and Order and Further Notice of Proposed Rulemaking, FCC 16-64 (Phase II Auction Order). In August 2016, the Commission adopted a plan tailored to certain carriers, both fixed and mobile, serving Alaska. Connect America Fund et al., WC Docket No. 10-90 et al., Report and Order and Further Notice of Proposed Rulemaking, FCC 16-115 (Alaska Plan Order). Also, in January 2017 the Commission adopted an order which granted New York State waiver of the Connect America Phase II auction program rules, subject to certain conditions. Connect America Fund et al., WC Docket Nos. 10-90 et al., FCC 17-2 (New York Auction Order). The Commission made up to $170.4 million in Connect America Phase II support available to applicants selected in New York's New NY Broadband Program in accordance with the framework adopted in the order. New York winning bidders that are ultimately authorized to receive Connect America Phase II support will be subject to the same location reporting, build-out milestone certifications, and non-compliance measures as Connect America Phase II auction recipients.

This information collection addresses the requirement that certain carriers with high cost reporting obligations must file information about their locations which meet their broadband deployment public interest obligations via an electronic portal (“portal”). The Rate-of-Return Order required that the Universal Service Administrative Company (USAC) establish the portal so that carriers could file their location data with the portal starting in 2017. The Rate-of-Return Order required all recipients of Phase II model-based support and rate-of-return carriers to submit geocoded location data and related certifications to the portal. Recipients of Phase II model-based support had been required to file such information in their annual reports due by July 1. The Phase II Auction Order requires auction winners to build-out networks capable of meeting their public interest obligations and report, to an online portal, locations to which auction winners had deployed such networks. This information collection also addresses the new portal reporting requirements for carriers receiving Alaska Plan support, including their submission of fiber/microwave middle-mile network maps, and recipients of Phase II support that is awarded in partnership with New York's New NY Broadband Program.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-XXXX.

Title: Mobility Fund Phase II Challenge Process.

Form Number: N/A.

Type of Review: New information collection.

Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

Estimated Number of Respondents and Responses: 500 respondents and 500 responses.

Estimated Time per Response: 204 hours for challengers; 71 hours for challenged parties.

Frequency of Response: One-time reporting requirement.

Obligation To Respond: Required to obtain or retain benefits. Statutory authority for the currently approved information collection is contained in sections 154, 254, and 303(r) of the Communications Act, as amended, 47 U.S.C. 4, 254, 303(r).

Estimated Total Annual Burden: 78,725 hours.

Total Annual Costs: None.

Nature and Extent of Confidentiality: To the extent the information submitted pursuant to this information collection is determined to be confidential, it will be protected by the Commission. If a respondent seeks to have information collected pursuant to this information collection withheld from public inspection, the respondent may request confidential treatment pursuant to section 0.459 of the Commission's rules for such information. See 47 CFR 0.459.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: A request for approval of this new information collection is being submitted to the Office of Management and Budget (OMB) to obtain the full three-year clearance from OMB. In its November 2011 USF/ICC Transformation Order (FCC 11-161), the Commission established the Mobility Fund, which consists of two phases. Mobility Fund Phase I (MF-I) provided one-time universal service support payments to immediately accelerate deployment of mobile broadband services. MF-II will use a reverse auction to provide ongoing universal service support payments to continue to advance deployment of such services. The Commission adopted the rules and framework for MF-I in the USF/ICC Transformation Order, and sought comment in an accompanying further notice of proposed rulemaking on the proposed framework for MF-II. In its February 2017 Mobility Fund II Report and Order and Further Notice of Proposed Rulemaking (MF-II Report and Order and/or FNPRM) (FCC 17-11), the FCC adopted the rules and framework for moving forward expeditiously with the MF-II auction. Among other things, the Commission stated in the MF-II Report and Order that, prior to the auction, it would establish a map of areas presumptively eligible for MF-II support based on the most recently available FCC Form 477 mobile wireless coverage data, and provide a limited timeframe for parties to challenge those initial determinations during the pre-auction process. The Commission sought comment in the accompanying Mobility Fund II FNPRM on how to best design a robust, targeted MF-II challenge process that efficiently resolves disputes about the areas eligible for MF-II support. In August 2017, the Commission released an Order on Reconsideration and Second Report and Order (Challenge Process Order) (FCC 17-102) in which it (1) reconsidered its earlier decision to use FCC Form 477 data to compile the map of areas presumptively eligible for MF-II support and decided it would instead conduct a new, one-time data collection with specified data parameters tailored to MF-II to determine the areas in which there is deployment of qualified LTE that will be used (together with high-cost disbursement data available from the Universal Service Administrative Company (USAC)) for this purpose, and (2) adopted a streamlined challenge process that will efficiently resolve disputes about areas deemed presumptively ineligible for MF-II support. The map of areas presumptively eligible for MF-II support will serve as the starting point for the challenge process pursuant to which an interested party (challenger) may initiate a challenge with respect to one or more areas initially deemed ineligible for MF-II support (i.e., areas not listed on the Commission's map of areas presumptively eligible for MF-II support and challenged parties can respond to challenges. A challenger seeking to initiate a challenge of one or more areas initially deemed ineligible in the Commission's map of areas presumptively eligible for MF-II support may do so via the online challenge portal developed by USAC for this purpose (the USAC portal). For each state, a challenger must (1) identify the area(s) it seeks to challenge, (2) submit detailed proof of a lack of unsubsidized, qualified 4G LTE coverage in each challenged area in the form of actual outdoor speed test data collected using the standardized parameters specified by the Commission in the Challenge Process Order and any other parameters the Commission or the Wireless Telecommunications Bureau and Wireline Competition Bureau (the Bureaus) may implement, and (3) certify its challenge.

After the challenge window closes, the USAC system will use an automated challenge validation process developed by USAC to validate a challenger's evidence and will determine which challenged areas pass validation and which fail. Once all valid challenges have been identified, a challenged party that chooses to respond to any valid challenge(s) will have a response window within which to submit additional data via the online USAC portal. A challenged party may submit technical information that is probative regarding the validity of a challenger's speed tests (i.e., information demonstrating that the challenger's speed tests are invalid or do not accurately reflect network performance), including speed test data and other device-specific data collected from transmitter monitoring software or, alternatively, may submit its own speed test data that conforms to the same standards and requirements specified by the Commission and the Bureaus for challengers.

In conjunction with the qualified 4G LTE data separately collected pursuant to OMB 3060-1242 that will be used to create the map of areas presumptively eligible for MF-II support, the information collected under this new MF-II challenge process collection will enable the Commission to efficiently resolve disputes concerning the eligibility or ineligibility of an area initially deemed ineligible for MF-II support and establish the final map of areas eligible for such support, thereby furthering the Commission's goal of targeting MF-II support to areas that lack adequate mobile voice and broadband coverage absent subsidies through a transparent process.

As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control No.: 3060-0686.

Title: International Section 214 Process and Tariff Requirements—47 CFR sections 63.10, 63.11, 63.13, 63.18, 63.19, 63.21, 63.22, 63.24, 63.25 and 1.1311.

Form No.: International Section 214—New Authorization; International Section 214 Authorization—Transfer of Control/Assignment; International Section 214—Special Temporary Authority and International Section 214—Foreign Carrier Affiliation Notification.

Type of Review: Revision of a currently approved information collection.

Respondents: Business or other for-profit.

Number of Respondents: 528 respondents; 792 responses.

Estimated Time per Response: 1-20 hours.

Frequency of Response: On occasion reporting requirement, Quarterly reporting requirement, Recordkeeping requirement and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The Commission's statutory authority for this information collection under sections 1, 4(i), 4(j), 10, 11, 201-205, 208, 211, 214, 218, 219, 220, 303(r), 309, 310, 403 and 571 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 154(j), 160, 161, 201-205, 208, 211, 214, 218, 219, 220, 303(r), 309, 310, 403 and 571.

Total Annual Burden: 3,152 hours.

Annual Cost Burden: $752,400.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The Commission has not granted assurances of confidentiality to those parties submitting the information, except for the list or routes required under 47 CFR 63.22(h) which the Commission will treat as not routinely available for public inspection. In all the other cases where a respondent believes information requires confidentiality, the respondent can request confidential treatment under Section 0.459 of the Commission's rules, 47 CFR 0.459.

Needs and Uses: The Federal Communications Commission (“Commission”) is requesting that the Office of Management and Budget (OMB) approve a revision of OMB Control No. 3060-0686 titled, “International Section 214 Authorization Process and Tariff Requirements—47 CFR Sections 63.10, 63.11, 63.13, 63.18, 63.19, 63.21, 63.24, 63.25 and 1.1311.” The purpose of this revision is to obtain OMB approval for the reporting requirements under newly adopted 47 CFR 63.22(h), which requires facilities-based international service providers electronically to submit, and maintain, a list of routes on which they have direct termination arrangements with a foreign carrier. In addition, this list maybe used to initiate targeted data collections regarding those routes. Finally, we remove from this collection the requirements related to 47 U.S.C. 310(b) which are now included in the collection under OMB Control No. 3060-1163.

The current title of OMB Control No. 3060-0686 is “International Section 214 Process and Tariff Requirements—47 CFR Sections 63.10, 63.11, 63.13, 63.18, 63.19, 63.21, 63.24, 63.25 and 1.1311”. The Commission would like to change the title to “International Section 214 Process and Tariff Requirements—47 CFR Sections 63.10, 63.11, 63.13, 63.18, 63.19, 63.21, 63.22, 63.24, 63.25 and 1.1311” to reflect the addition of 47 CFR 63.22(h) to the information collection.

The information will be used by the Commission staff in carrying out its duties under the Communications Act. The information collections pertaining to Part 63 are necessary largely to determine the qualifications of applicants to provide common carrier international telecommunications service under section 214 of the Communications Act, 47 U.S.C. 214, including applicants that are, or are affiliated with, foreign carriers, and to determine whether and under what conditions the authorizations are in the public interest, convenience, and necessity. The information collections are also necessary to maintain effective oversight of U.S. international carriers generally.

The frequency of filing applications pursuant to Sections 214 will be determined largely by the applicant seeking to provide U.S international common carrier service under section 214 of the Communications Act, 47 U.S.C. 214. Carriers will also determine largely the frequency of filing under the other rules included in this collection, with the exception of the quarterly reports required of certain carriers under 47 CFR 63.10(c) and the list of routes for which a facilities-based international service provider must make a one-time filing and update as necessary under 47 CFR 63.22(h). If the collections are not conducted or are conducted less frequently, applicants will not obtain the authorizations necessary to provide telecommunications services, and the Commission will be unable to carry out its mandate under the Communications Act of 1934. In addition, without the information collections, the United States would jeopardize its ability to fulfill the U.S. obligations as negotiated under the World Telecommunications Organization (WTO) Basic Telecom Agreement because these collections are imperative to detecting and deterring anticompetitive conduct. They are also necessary to preserve the Executive Branch agencies' and the Commission's ability to review foreign investments for national security, law enforcement, foreign policy, and trade concerns. Regarding 47 CFR 63.11, carriers determine largely when to notify the Commission of planned investments by or in foreign carriers. If the information is not collected by the Commission, we will not be able to prevent carriers that control bottleneck facilities in foreign countries from using those bottlenecks to discriminate against unaffiliated U.S. carriers.

The notice of this meeting was first published in the Federal Register on December 5, 2017, only 7 days in advance of the meeting. While the publication did not meet the 15-day requirement for advance publication, exceptional circumstances warrant proceeding with the December 12, 2017 CSRIC meeting. CSRIC members and the public were informed of the December 12 meeting at the October 26, 2017 public meeting of the Council, and CSRIC members have been advised informally of the December meeting date on more than one occasion since then. In addition, the date of the December meeting has been available on the FCC's CSRIC website for at two months. A significant number of Council members have made business and travel plans in accordance with this schedule, and there is no date within one month of the planned date that will accommodate Council members' schedules. Delaying the meeting will cause undue financial burdens on many of the members and any members of the public who have made travel arrangements.

In addition, it is not possible at this time to schedule a half-day meeting in the FCC's Commission Meeting Room for any date within one month of December 12, 2017. As the December 2017 meeting date was announced at the October 2017 public meeting of the Council, the meeting has now been broadly announced to the public more than once.

The December 5, 2017, Federal Register notice is available at 82 FR 57444 (December 5, 2017) and https://www.federalregister.gov/documents/2017/12/05/2017-26159/federal-advisory-committee-act-communications-security-reliability-and-interoperability-council.

Additional information regarding the CSRIC can be found at: https://www.fcc.gov/about-fcc/advisory-committees/communications-security-reliability-and-interoperability-council.

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Final approval under OMB delegated authority of the extension for three years, without revision, of the following report:

Report title: Quarterly Savings and Loan Holding Company Report.

Agency form number: FR 2320.

OMB control number: 7100-0345.

Frequency: Quarterly.

Respondents: Savings and loan holding companies (SLHCs) that are currently exempt from filing other Federal Reserve regulatory reports.

Estimated number of respondents: 15.

Estimated average hours per response: 2.5 hours.

Estimated annual burden hours: 150 hours.

General Description of Report: The FR 2320 collects select parent only and consolidated balance sheet and income statement financial data and organizational structure data from SLHCs that are currently exempt from filing other Federal Reserve regulatory reports (exempt SLHCs).1 The FR 2320 is used by the Board to analyze the overall financial condition of exempt SLHCs to ensure safe and sound operations. These data assist the Board in the evaluation of a diversified holding company and in determining whether an institution is in compliance with applicable laws and regulations.

Legal authorization and confidentiality: The Board has determined that the Home Owners' Loan Act authorizes the Board to require SLHCs to file “such reports as may be required by the Board” and instructs that such reports “shall contain such information concerning the operations of such savings and loan holding company and its subsidiaries as the Board may require.” (12 U.S.C. 1467a(b)(2)). The obligation to respond is mandatory for exempt SLHCs. In some cases, lower-tier SLHCs may voluntarily file the FR 2320. In other cases lower-tier SLHCs may be required to file (in addition to the top-tier SLHC) for safety and soundness purposes at the discretion of the appropriate Federal Reserve Bank.

The Board also has determined that data items C572, C573, and C574 (line items 24, 25, and 26) may be protected from disclosure under exemption 4 of the Freedom of Information Act (FOIA). Commercial or financial information may be protected from disclosure under exemption 4 if disclosure of such information is likely to cause substantial competitive harm to the provider of the information. (5 U.S.C. 552(b)(4)). The data items listed above pertain to new or changed pledges, or capital stock of any subsidiary savings association that secures short-term or long-term debt or other borrowings of the SLHC; changes to any class of securities of the SLHC or any of its subsidiaries that would negatively impact investors; and defaults of the SLHC or any of its subsidiaries during the quarter. Disclosure of this type of information is likely to cause substantial competitive harm to the SLHC providing the information and thus this information may be protected from disclosure under FOIA exemption 4.

With regard to the remaining data items on the FR 2320, the Board has determined that institutions may request confidential treatment for any FR 2320 data item or for all FR 2320 data items, and that confidential treatment will be reviewed on a case-by-case basis.

Current actions: On August 23, 2017, the Federal Reserve published a notice in the Federal Register (82 FR 40000) requesting public comment for 60 days on the extension, without revision, of the Quarterly Savings and Loan Holding Company Report. The comment period for this notice expired on October 23, 2017. The Board did not receive any comments.

On August 30, 2017, the Board published a notice and request for public comment (Request for Information) on the proposal that FRBNY, in coordination with OFR, produce and publish three rates based on overnight repurchase agreement (repo) transactions on U.S. Treasury securities (Treasury repo).1 The three rates (collectively, the “Treasury repo rates”) would be based on transaction-level data from various segments of the repo market.

The Request for Information indicated that this rate would be a measure of rates on overnight, specific-counterparty tri-party Treasury general collateral (GC) repo. This rate would be calculated based on transaction-level tri-party repo data collected from the Bank of New York Mellon (BNYM) under the Board's supervisory authority. The rate would exclude General Collateral Finance (GCF) Repo® cleared by the Fixed Income Clearing Corporation (FICC) and transactions in which a Federal Reserve Bank is a counterparty.2

The Request for Information indicated that this rate would provide a broad measure of rates on overnight Treasury GC repo transactions. The rate would be calculated based on the same transaction-level tri-party repo data collected from BNYM as in the TGCR plus GCF Repo data obtained from DTCC Solutions LLC (DTCC Solutions), an affiliate of the Depository Trust & Clearing Corporation (DTCC).

The Request for Information indicated that this rate would provide a broad measure of the general cost of financing Treasury securities overnight. The rate would be calculated based on the tri-party data from BNYM and GCF Repo data from DTCC Solutions used to calculate the BGCR, plus bilateral Treasury repo transactions cleared through FICC's Delivery-versus-Payment (DVP) service, filtered to remove some (but not all) transactions considered “specials.” 3 This rate would not be a pure GC repo rate, but would offer the broadest measure of dealers' cost of financing Treasury securities overnight.

The Request for Information stated that FRBNY would use a volume-weighted median as the central tendency measure for each of the three Treasury repo rates described above. FRBNY would publish summary statistics to accompany the daily publication of the rate, which would consist of the 1st, 25th, 75th and 99th volume-weighted percentile rates, as well as volumes.

The Request for Information included a target publication time of 8:30 a.m. ET. The Request for Information stated that the rates would be revised only on a same-day basis, and only if the revision would result in a shift in the volume-weighted median by more than one basis point. Such revisions would be effected that same day at or around 2:30 p.m. ET and would result in a republication of updated summary statistics. If relevant data sources were unavailable, the Request for Information stated that the rates would be calculated based upon back-up repo market survey data collected from FRBNY's primary dealer counterparties. In such circumstances, the Request for Information indicated that FRBNY might revise the summary statistics or publish additional summary statistics on a lagged basis.

For each rate, the Request for Information stated that FRBNY would exclude trades between affiliated entities when relevant and when the data to make such exclusions is available. To the extent possible, “open” trades for which pricing resets daily (making such transactions economically similar to overnight transactions) would be included in the calculation of the rates.

Finally, the Request for Information stated that each of the rates could be modified in the future in response to market evolution or to incorporate additional market segments if data become available.

The Board received twelve comments on the Request for Information from financial institutions and industry associations. Certain commenters focused on possible uses of the proposed rates, including the possibility that the proposed rates (particularly SOFR) could serve as reference rates for financial contracts. Other commenters focused on the calculation, publication, and governance of the proposed rates.

Commenters suggested that the proposed rates would be useful because they would provide a comprehensive view of pricing in the Treasury repo market, would provide a good proxy for a risk-free rate, would provide useful information regarding overnight demand and supply for funding, and could facilitate the creation of futures contracts that would allow market participants to hedge Treasury repos and spot-market Treasury purchases. Most commenters who expressed a view on the potential uses of the proposed rates suggested that SOFR would be more useful than the other rates because SOFR would provide a broader measure of pricing in the Treasury repo market.

Other commenters raised concerns regarding the possible use of SOFR as a replacement for the London Interbank Offered Rate (LIBOR) in financial contracts. For example, a number of commenters believed that U.S. dollar LIBOR should be replaced with term reference rates or rates that reflect bank credit risk in ways that are similar to U.S. dollar LIBOR. Some commenters also noted difficulties in amending certain existing contracts (e.g., syndicated loan and corporate bond contracts) to replace U.S. dollar LIBOR.

Based on public comments, the Board believes that market participants could use the proposed Treasury repo rates in a variety of ways. The Board recognizes that the proposed rates could be used as reference rates in financial contracts, and that the Alternative Reference Rates Committee (ARRC) has selected SOFR as its recommended alternative to U.S. Dollar LIBOR.4 The Board notes, however, that the proposal to publish these rates was not contingent upon the ARRC's selection of SOFR or the possible use of SOFR (or either of the other proposed rates) as a reference rate in financial contracts. As noted in the Request for Information, the publication of the Treasury repo rates is intended to improve transparency into the repo market by increasing the amount and quality of information available about the market for overnight Treasury repo activity. This information could be useful to market participants in a variety of ways. To the extent that market participants choose to use SOFR or another of the Treasury repo rates as a reference rate, details regarding the transition from U.S. Dollar LIBOR to that rate in particular markets are outside the scope of the Request for Information and this final Federal Register notice.

The Board received a number of comments on the calculation, publication, and governance of the proposed rates. Commenters discussed the types of data that FRBNY will include in the rates, FRBNY's calculation methodology, and various issues related to publication and governance of the rates.

Three commenters suggested that the Federal Reserve and OFR should consider including additional Treasury repo activity in the proposed rates (e.g., uncleared bilateral repos, FICC's Sponsored DVP Repo Service, and FICC's new CCITTM Service) and should adopt a clear mechanism for including additional Treasury repo activity in the future. As noted in the Request for Information, each of the Treasury repo rates could be modified in the future in response to market evolution or to incorporate additional market segments if data become available. The Federal Reserve and OFR will monitor trading activity in new market segments and will consult with the public in deciding whether to include new data sources in the Treasury repo rates or make other compositional or methodological changes to the rates. The Board also notes that (1) FRBNY cannot currently include data regarding uncleared bilateral repos in the Treasury repo rates because there is no available data source for such information and (2) SOFR will include data from FICC's Sponsored DVP Repo Service.

A commenter asked the Board to provide more information regarding FRBNY's contract to acquire data from DTCC Solutions, stating that additional information would help market participants evaluate potential risks related to loss of access to data. The Federal Reserve and OFR are confident that the combination of the relevant provisions of the contract with DTCC Solutions and the data collection authorities of the OFR and Federal Reserve will ensure that they will be able to continue to produce robust rates under a variety of circumstances. In this regard, the Board notes that OFR informed the Financial Stability Oversight Council on November 16, 2017, that it intends to propose an information collection in the first half of 2018 to collect data regarding cleared repo transactions.5

Finally, a commenter suggested that the Board should use its supervisory authority to ensure that BNYM conducts its tri-party operations properly, including appropriate business continuity and other risk contingency planning. BNYM is a State member bank and is subject to comprehensive supervision by the Federal Reserve.6 In particular, the Federal Reserve supervises BYNM's tri-party operations.7

Two commenters supported the proposal to calculate the Treasury repo rates using a volume-weighted median approach. One commenter suggested, however, that a volume-weighted average might be more appropriate because SOFR could have a bimodal distribution, with one peak representing relatively low tri-party rates and a second peak reflecting higher rates for GCF repos and repos cleared through FICC's DVP service. This commenter believed that, if SOFR has a bimodal distribution, small changes in the relative volumes of the two peaks could result in significant shifts in the median rate. FRBNY will use a volume-weighted median approach because, compared to a volume-weighted mean approach, it is more robust to erroneous data and outliers and more frequently reflects a transacted rate. Although the aggregation of heterogeneous market segments increases the risk of a multimodal distribution, FRBNY's historical analysis indicates that use of a volume-weighted median did not materially increase the volatility of the rate and that small shifts in the data did not cause significant shifts in the median rate. The Federal Reserve and OFR will review the composition and methodology of the rates over time and, as noted above, will consult with the public in deciding whether to make any compositional or methodological changes.

Multiple commenters asked the Board to clarify how FRBNY will trim specials from the proposed rates. One commenter supported exclusion of all bilateral transactions below the 25th volume-weighted percentile rate, while two commenters stated that they would need more data to evaluate whether this approach is sensible. Another commenter suggested other possible techniques for excluding outlier transactions. Federal Reserve and OFR staff considered several techniques for trimming specials activity, including removing all transactions collateralized by on-the-run and first-off-the-run securities.8 The Board confirms that FRBNY will trim specials by excluding from the FICC-cleared bilateral data all transactions with rates below the 25th volume-weighted percentile. Analysis of various volume-weighted percentile thresholds revealed that excluding all activity trading below the 25th percentile rate struck an appropriate balance between removing the largest number of specials transactions and maintaining robust volume to use in calculating a rate.9 This approach effectively removes transactions with rates that are notably lower than other transactions in the FICC-cleared bilateral data set, which indicates that the removed transactions are specials.

A commenter requested more information about how FRBNY will include “open” trades in the proposed rates. Open transactions are transactions with no specific maturity date for which the interest rate is periodically reset upon agreement by both borrower and lender. Although there are many forms of open transactions with different reset periods, those with daily rate resets are economically very similar to overnight transactions. On January 24, 2017, the Treasury Market Practices Group recommended a new best practice in the recording of daily-resetting open trades, which is expected to make daily-resetting trades easier to differentiate from open trades with different reset periods.10

Two commenters noted that SOFR tends to spike at quarter-ends and suggested that FRBNY apply a “smoothing” mechanism to minimize volatility of the proposed rates. The Board recognizes that rates in some segments of the Treasury repo market currently tend to increase at quarter-ends, but FRBNY will not apply a smoothing mechanism to the Treasury repo rates because doing so would provide an inaccurate view of that day's pricing in the Treasury repo market.

Finally, one commenter suggested that, even though the proposed rates would exclude transactions in which a Federal Reserve Bank is a counterparty, Federal Reserve activity in repo markets might distort rates in Treasury repos that do not involve a Federal Reserve Bank. The Federal Reserve implements monetary policy through multiple types of financial transactions, including repos. These open market operations affect all money market rates. The Board nevertheless believes that the Treasury repo rates will provide market participants with a transparent and comprehensive view of pricing in the Treasury repo market.

One commenter stated that the proposed 8:30 a.m. ET publication time was appropriate. Another commenter asked the Federal Reserve to consider carefully whether publishing the rates at 8:30 a.m. would impact efficient market functioning. Three commenters believed that the proposed rates should be published earlier, explaining that 8:30 a.m. publication would be too late for some foreign financial markets and on certain days would coincide with some U.S. economic data releases. FRBNY will shift the publication time at least as early as 8:00 a.m. ET to avoid coincident release with key U.S. economic data. The Board and FRBNY will consider whether FRBNY can publish Treasury repo rates even earlier, but operational constraints—for example, constraints on the ability of FRBNY's data providers to produce and deliver data overnight and the time required for FRBNY to perform data validation and quality assurance processes—may prevent earlier publication.

A commenter asked for an explanation of how FRBNY would publish the proposed rates. FRBNY will publish the Treasury repo rates on its public website, similar to the manner in which FRBNY currently publishes the effective federal funds rate (EFFR) and the overnight bank funding rate (OBFR).11

Four commenters supported the proposal to publish summary statistics. One of these commenters suggested, however, that publishing statistics from the 1st and 99th percentiles would not be informative, and that FRBNY should instead publish summary statistics for percentiles between the 1st and 25th/75th and 99th percentiles (e.g., the 5th and 95th percentiles). Initially, FRBNY will publish summary statistics as described in the Request for Information, and may publish additional percentiles on a lagged basis. After FRBNY begins publishing the Treasury repo rates, FRBNY will reassess whether market participants would benefit from additional summary statistics.

Three commenters requested that FRBNY publish historical data for SOFR. Commenters believed that historical data would serve a number of purposes—for example, commenters suggested that historical data would help market participants determine margin requirements for derivatives that reference SOFR and would help market participants compare SOFR to existing benchmarks. The Board recognizes that market participants might benefit from historical data. While longer histories of comparable commercially produced repo rates are publicly available, the Board believes that a significantly longer history of the Treasury repo rates may not be possible due to limitations on the availability of data. The Board and FRBNY will work with BNYM and DTCC to determine whether FRBNY can publish additional historical data for the Treasury repo rates.

Two commenters suggested that the proposed threshold of “greater than one basis point” for revising the proposed rates was too sensitive. Another commenter explained that its members had not achieved consensus on the threshold at which FRBNY should revise errors, but the commenter emphasized that FRBNY should articulate a clear rationale for its revision policy. The Board notes that, because FRBNY will round the Treasury repo rates to the nearest whole basis point, the threshold is effectively two basis points. The Board also notes that this is the same threshold employed for EFFR and OBFR, for which revisions are very rare. The Federal Reserve will periodically review the revision threshold to ensure that revisions are very rare and do not impose undue operational costs on users of the Treasury repo rates.

A commenter asked whether FRBNY would publish the proposed rates if relevant data sources were unavailable and, if so, whether FRBNY would correct such rates retroactively when data becomes available. Another commenter suggested that FRBNY should provide more information regarding the back-up repo market survey it would conduct if standard data sources are unavailable. As noted in the Request for Information, in the event that data sources are unavailable, the Treasury repo rates would be calculated based upon back-up repo market survey data collected from FRBNY's primary dealer counterparties. FRBNY currently collects repo data from primary dealers each morning. Going forward, FRBNY will also collect data each afternoon. The afternoon survey will capture that day's activity by primary dealers and will be available as a contingency data source for the following morning's publication of the Treasury repo rates. The survey will request aggregated primary dealer activity in each of the market segments captured in the Treasury repo rates: Overnight tri-party Treasury repo transactions, overnight Treasury repo transactions in the GCF market, and FICC-cleared bilateral Treasury repo transactions. For each of these market segments, each dealer will report its aggregate borrowing activity (excluding, to the extent possible, transactions between affiliated entities and transactions in which the Federal Reserve is a counterparty), along with the weighted-average rate of its borrowing. If FRBNY publishes Treasury repo rates that use survey data and subsequently receives updated data, FRBNY would issue same-day revisions at or around 2:30 p.m. ET if the use of updated data would result in the published rate changing by more than one basis point.

Finally, two commenters asked that FRBNY begin publishing the Treasury repo rates as soon as possible. FRBNY intends to begin publishing the Treasury repo rates in the second quarter of 2018.

A commenter suggested that governance arrangements for the Treasury repo rates should align with the Principles for Financial Benchmarks published by the International Organization of Securities Commissions (IOSCO) in July 2013.12 FRBNY plans to publish an IOSCO statement of compliance covering the Treasury repo rates in the first half of 2018.

After considering public comments, the Board concludes that the public would benefit if FRBNY publishes the three Treasury repo rates as proposed, with certain modifications described above.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR part 1320, Appendix A.1), the Board reviewed the Request for Information and this final notice under the authority delegated to the Board by the Office of Management and Budget. For purposes of calculating burden under the Paperwork Reduction Act, a “collection of information” involves 10 or more respondents. As noted above, the data to be used to produce the rates will be obtained solely from (1) BNYM with respect to tri-party GC repo data and (2) DTCC Solutions with respect to GCF repo data and DVP bilateral repo data. Therefore, producing the rates will not involve a collection of information pursuant to the Paperwork Reduction Act.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) generally requires an agency to perform an initial and a final regulatory flexibility analysis on the impact a rule is expected to have on small entities. The RFA imposes these requirements in situations where an agency is required by law to publish a general notice of proposed rulemaking for any proposed rule. The production of the rates does not create any obligations or rights for any private parties, including any small entities, and so the Board was not required to publish a notice of proposed rulemaking. Accordingly, the RFA does not apply and an initial and final regulatory flexibility analysis is not required.

The Board did not receive any comments regarding the Paperwork Reduction Act or the RFA.

Medicare may cover ambulance services, including air ambulance (fixed-wing and rotary-wing) services, if the ambulance service is furnished to a beneficiary whose medical condition is such that other means of transportation are contraindicated. The beneficiary's condition must require both the ambulance transportation itself and the level of service provided in order for the billed service to be considered medically necessary.

Non-emergent transportation by ambulance is appropriate if either the—(1) beneficiary is bed-confined and it is documented that the beneficiary's condition is such that other methods of transportation are contraindicated; or (2) beneficiary's medical condition, regardless of bed confinement, is such that transportation by ambulance is medically required. Thus, bed confinement is not the sole criterion in determining the medical necessity of non-emergent ambulance transportation; rather, it is one factor that is considered in medical necessity determinations.1

A repetitive ambulance service is defined as medically necessary ambulance transportation that is furnished in 3 or more round trips during a 10-day period, or at least 1 round trip per week for at least 3 weeks.2 Repetitive ambulance services are often needed by beneficiaries receiving dialysis or cancer treatment.

Medicare may cover repetitive, scheduled non-emergent transportation by ambulance if the—(1) medical necessity requirements described previously are met; and (2) ambulance provider/supplier, before furnishing the service to the beneficiary, obtains a written order from the beneficiary's attending physician certifying that the medical necessity requirements are met (see 42 CFR 410.40(d)(1) and (2)).3

In addition to the medical necessity requirements, the service must meet all other Medicare coverage and payment requirements, including requirements relating to the origin and destination of the transportation, vehicle and staff, and billing and reporting. Additional information about Medicare coverage of ambulance services can be found in 42 CFR 410.40, 410.41, and in the Medicare Benefit Policy Manual (Pub. L. 100-02), Chapter 10, at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c10.pdf.

According to a study published by the Government Accountability Office in October 2012, entitled “Costs and Medicare Margins Varied Widely; Transports of Beneficiaries Have Increased,” 4 the number of basic life support (BLS) non-emergent transports for Medicare Fee-For-Service beneficiaries increased by 59 percent from 2004 to 2010. A similar finding published by the Department of Health and Human Services' Office of Inspector General in a 2006 study, entitled “Medicare Payments for Ambulance Transports,” 5 indicated a 20 percent nationwide improper payment rate for non-emergent ambulance transport. Likewise, in June 2013, the Medicare Payment Advisory Commission published a report 6 that included an analysis of non-emergent ambulance transports to dialysis facilities and found that, during the 5-year period between 2007 and 2011, the volume of transports to and from a dialysis facility increased 20 percent, more than twice the rate of all other ambulance transports combined.

Section 1115A of the Social Security Act (the Act) authorizes the Secretary to test innovative payment and service delivery models to reduce program expenditures, while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. Section 1115A(d)(1) of the Act authorizes the Secretary to waive such requirements of Titles XI and XVIII, as well as sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and 1934 (other than subsections (b)(1)(A) and (c)(5)) of the Act as may be necessary solely for purposes of carrying out section 1115A of the Act with respect to testing models described in section 1115A(b) of the Act. Consistent with this standard, we will continue to waive the same provisions for the extension of this model as have been waived for the initial three years of the model. Additionally, we have determined that the implementation of this model does not require the waiver of any fraud and abuse law, including sections 1128A, 1128B, and 1877 of the Act. Thus providers and suppliers affected by this model must comply with all applicable fraud and abuse laws.

In the November 14, 2014 Federal Register (79 FR 68271), we published a notice entitled “Medicare Program; Prior Authorization of Repetitive Scheduled Non-emergent Ambulance Transports,” which announced the implementation of a 3-year Medicare Prior Authorization model that established a process for requesting prior authorization for repetitive, scheduled non-emergent ambulance transport rendered by ambulance providers/suppliers garaged in 3 states (New Jersey, Pennsylvania, and South Carolina). These states were selected as the initial states for the model because of their high utilization and improper payment rates for these services. The model began on December 1, 2014, and was originally scheduled to end in all 3 states on December 1, 2017.

In the October 23, 2015 Federal Register (80 FR 64418), we published a notice titled “Medicare Program; Expansion of Prior Authorization of Repetitive Scheduled Non-emergent Ambulance Transports,” which announced the inclusion of 6 additional states (Delaware, the District of Columbia, Maryland, North Carolina, West Virginia, and Virginia) in the Repetitive Scheduled Non-Emergent Ambulance Transport Prior Authorization model in accordance with section 515(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10). These 6 states began participation on January 1, 2016, and the model was originally scheduled to end in all nine model states on December 1, 2017.

This notice announces that the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport is being extended in the current model states of Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia, effective December 5, 2017, for an additional year to allow for additional evaluation of the model. Repetitive, scheduled non-emergent ambulance transport claims with dates of service of December 2, 2017 through December 4, 2017 will not be stopped for prepayment review if prior authorization is not requested before the fourth round trip in a 30-day period; however, providers, suppliers, and beneficiaries may request prior authorization for these dates of service. The model will now end in all states on December 1, 2018. Prior authorization will not be available for repetitive scheduled non-emergent ambulance transportation services furnished after that date.

We will continue to test whether prior authorization helps reduce expenditures, while maintaining or improving quality of care, using the established prior authorization process for repetitive, scheduled non-emergent ambulance transport to reduce utilization of services that do not comply with Medicare policy.

We will continue to use this prior authorization process to help ensure that all relevant clinical or medical documentation requirements are met before services are furnished to beneficiaries and before claims are submitted for payment. This prior authorization process further helps to ensure that payment complies with Medicare documentation, coverage, payment, and coding rules.

The use of prior authorization does not create new clinical documentation requirements. Instead, it requires the same information that is already required to support Medicare payment, just earlier in the process. Prior authorization allows providers and suppliers to address coverage issues prior to furnishing services.

The prior authorization process under this model will continue to apply in the nine states listed previously for the following codes for Medicare payment:

• A0426 Ambulance service, advanced life support, non-emergency transport, Level 1 (ALS1).

• A0428 Ambulance service, BLS, non-emergency transport.

While prior authorization is not needed for the mileage code, A0425, a prior authorization decision for an A0426 or A0428 code will automatically include the associated mileage code.

We have conducted and will continue to conduct outreach and education to ambulance providers/suppliers, as well as beneficiaries, through such methods as updating the operational guide, frequently asked questions (FAQs) on our website, a physician letter explaining the ambulance providers/suppliers' need for the proper documentation, and educational events and materials issued by the Medicare Administrative Contractors (MACs). We are also working to implement a new process that will help identify alternate transportation resources for beneficiaries who receive non-affirmative decisions. Additional information about the implementation of the prior authorization model is available on the CMS website at http://go.cms.gov/PAAmbulance.

Under this model, submitting a prior authorization request is voluntary. However, an ambulance provider/supplier or beneficiary is encouraged to submit to the MAC a request for prior authorization along with all relevant documentation to support Medicare coverage of a repetitive, scheduled non-emergent ambulance transport. If prior authorization has not been requested by the fourth round trip in a 30-day period, the subsequent claims will be stopped for prepayment review.

In order for a prior authorization request to be provisionally affirmed, the request for prior authorization must meet all applicable rules and policies, including any local coverage determination (LCD) requirements for ambulance transport claims. A provisional affirmation is a preliminary finding that a future claim submitted to Medicare for the service likely meets Medicare's coverage, coding, and payment requirements. After receipt of all relevant documentation, the MACs will make every effort to conduct a review and postmark the notification of their decision on a prior authorization request within 10 business days for an initial submission. Notification will be provided to the ambulance provider/supplier and to the beneficiary. If a subsequent prior authorization request is submitted after a non-affirmative decision on an initial prior authorization request, the MACs will make every effort to conduct a review and postmark the notification of their decision on the resubmitted request within 20 business days.

An ambulance provider/supplier or beneficiary may request an expedited review when the standard timeframe for making a prior authorization decision could jeopardize the life or health of the beneficiary. If the MAC agrees that the standard review timeframe would put the beneficiary at risk, the MAC will make reasonable efforts to communicate a decision within 2 business days of receipt of all applicable Medicare-required documentation. As this model is for non-emergent services only, we expect requests for expedited reviews to be extremely rare.

A provisional affirmative prior authorization decision may affirm a specified number of trips within a specific amount of time. The prior authorization decision, justified by the beneficiary's condition, may affirm up to 40 round trips (which equates to 80 one-way trips) per prior authorization request in a 60-day period. Alternatively, a provisional affirmative decision may affirm less than 40 round trips in a 60-day period, or may affirm a request that seeks to provide a specified number of transports (40 round trips or less) in less than a 60-day period. A provisional affirmative decision can be for all or part of the requested number of trips. Transports exceeding 40 round trips (or 80 one-way trips) in a 60-day period require an additional prior authorization request.

The following describes examples of various prior authorization scenarios:

• Scenario 1: When an ambulance provider/supplier or beneficiary submits a prior authorization request to the MAC with appropriate documentation and all relevant Medicare coverage and documentation requirements are met for the ambulance transport, the MAC will send a provisional affirmative prior authorization decision to the ambulance provider/supplier and the beneficiary. When the subsequent claim is submitted to the MAC by the ambulance provider/supplier, it is linked to the prior authorization decision via the claims processing system, and the claim will be paid so long as all Medicare coding, billing, and coverage requirements are met. However, the claim could be denied for technical reasons, such as the claim was a duplicate claim or the claim was for a deceased beneficiary. In addition, a claim denial could occur because certain documentation, such as the trip record, needed in support of the claim cannot be submitted with a prior authorization request because it is not available until after the service is provided.

• Scenario 2: When an ambulance provider/supplier or beneficiary submits a prior authorization request, but all relevant Medicare coverage requirements are not met, the MAC will send a non-affirmative prior authorization decision to the ambulance provider/supplier and to the beneficiary advising them that Medicare will not pay for the service. The provider/supplier or beneficiary may then resubmit the request with additional documentation showing that Medicare requirements have been met. Alternatively, an ambulance provider/supplier could furnish the service and submit a claim with a non-affirmative prior authorization tracking number, at which point the MAC would deny the claim. The ambulance provider/supplier and the beneficiary would then have the Medicare denial for secondary insurance purposes and would have the opportunity to submit an appeal of the claim denial if they think Medicare coverage was denied inappropriately.

• Scenario 3: When an ambulance provider/supplier or beneficiary submits a prior authorization request with incomplete documentation, a detailed decision letter will be sent to the ambulance provider/supplier and to the beneficiary, with an explanation of what information is missing. The ambulance provider/supplier or beneficiary can rectify the error(s) and resubmit the prior authorization request with appropriate documentation.

• Scenario 4: If an ambulance provider or supplier renders a service to a beneficiary and does not request prior authorization by the fourth round trip in a 30-day period, and the claim is submitted to the MAC for payment, then the claim will be stopped for prepayment review and documentation will be requested.

++ If the claim is determined to be for services that were not medically necessary or for which there was insufficient documentation, the claim will be denied, and all current policies and procedures regarding liability for payment will apply. The ambulance provider/supplier or the beneficiary, or both, can appeal the claim denial if they believe the denial was inappropriate.

++ If the claim is determined to be payable, it will be paid.

Under the model, we will work to limit any adverse impact on beneficiaries and to educate beneficiaries about the process. If a prior authorization request is non-affirmed, and the claim is still submitted by the ambulance provider/supplier, the claim will be denied, but beneficiaries will continue to have all applicable administrative appeal rights. We will also work to implement a process that will help identify alternate transportation resources for beneficiaries who receive non-affirmative decisions.

Only one prior authorization request per beneficiary per designated time period can be provisionally affirmed. If the initial ambulance provider/supplier cannot complete the total number of prior authorized transports (for example, the initial ambulance company closes or no longer services that area), the initial request is cancelled. In this situation, a subsequent prior authorization request may be submitted for the same beneficiary and must include the required documentation in the submission. If multiple ambulance providers/suppliers are providing transports to the beneficiary during the same or overlapping time period, the prior authorization decision will only cover the ambulance provider/supplier indicated in the provisionally affirmed prior authorization request. Any ambulance provider/supplier submitting claims for repetitive, scheduled non-emergent ambulance transports for which no prior authorization request is submitted by the fourth round trip in a 30-day period will be subject to 100 percent prepayment medical review of those claims.

Additional information is available on the CMS website at http://go.cms.gov/PAAmbulance.

Section 1115A(d)(3) of the Act states that chapter 35 of title 44, United States Code (the Paperwork Reduction Act of 1995), shall not apply to the testing and evaluation of models or expansion of such models under this section. Consequently, this document need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.

This document announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. Therefore, there are no regulatory impact implications associated with this notice.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States, imported, or exported from the United States, unless an approval of an application filed with FDA under section 505(b) or (j) of the FD&C Act is effective with respect to such drug. The Agency has codified regulations regarding applications for FDA approval to market a new drug under 21 CFR part 314. This collection of information supports the regulatory requirements found in those regulations. The collection of information is necessary for FDA to make a scientific and technical determination whether the product is safe and effective for use, and is summarized as follows:

Section 314.50(a) requires that an application form (Form FDA 356h) be submitted that includes information about the applicant, the submission, and a checklist of enclosures.

Section 314.50(b) requires that an index be submitted with the archival copy of the application and that it reference certain sections of the application.

Section 314.50(c) requires that a summary of the application be submitted that presents a good general synopsis of all the technical sections and other information in the application.

Section 314.50(d) requires that the new drug application (NDA) contain the following technical sections about the new drug: Chemistry, manufacturing, and controls; nonclinical pharmacology and toxicology; human pharmacokinetics and bioavailability; microbiology; clinical data; statistical; and pediatric use sections.

Section 314.50(e) requires the applicant to submit samples of the drug if requested by FDA. In addition, the archival copy of the application must include copies of the label and all labeling for the drug.

Section 314.50(f) requires that case report forms and tabulations be submitted with the archival copy.

Section 314.50(h) requires that patent information, as described under §  314.53, be submitted with the application. However, burden hours for §  314.50(h) are approved under OMB control numbers 0910-0513 (Patent Certification Forms FDA 3542 and FDA 3542a) and 0910-0786 (Abbreviated New Drug Applications (ANDAs) and 505(b)(2) Applications), and are therefore not included among the estimates found in table 1.

Section 314.50(i) requires that patent certification information be submitted in section 505(b)(2) applications for patents claiming the drug substance, drug product, or method of use. Sections 314.50(i)(1)(i)(C) and 314.54(i) and (j) require that patent certification information be submitted for each patent listed in the “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) for a drug product approved in an NDA that is pharmaceutically equivalent to the proposed drug product in the original 505(b)(2) application and was submitted and was approved before the original 505(b)(2) application was submitted. Burden for these provisions is included under OMB control number 0910-0786.

Section 314.50(j) requires that applicants who request a period of marketing exclusivity submit certain information with the application.

Section 314.50(k) requires that the application contain a financial certification or disclosure statement or both.

Section 314.50(l) requires that an archival, review, and field copy of the application be submitted, including the content of labeling and all labeling and labels.

Section 314.52 requires that any notice of certification of invalidity, unenforceability, or non-infringement of a patent to each patent owner and the NDA holder be sent by a section 505(b)(2) applicant that relies on a listed drug. A 505(b)(2) applicant is required to amend the application at the time notice is provided to include a statement certifying that the required notice has been provided. A 505(b)(2) applicant also is required to amend the application to document receipt of the required notice. Burden hours for these provisions are included in OMB control number 0910-0786.

Section 314.53 sets forth the patent information requirements for applicants who submit applications or amendments to the application filed under section 505(b)(2) of the FD&C Act or supplements to the approved 505(b)(2) application. Burden hours for these collections are approved in OMB control number 0910-0786.

Section 314.54 sets forth the content requirements for applications filed under section 505(b)(2) of the FD&C Act. The burden estimate for 505(b)(2) applications is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (l).

Section 314.55 sets forth the assessment requirements for each application. The burden estimate for 505(b)(2) applications is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (l).

Section 314.60 sets forth reporting requirements and patent certification requirements for sponsors who amend an unapproved 505(b)(2) application. Burden hours for the § 314.60(f) collections are approved under OMB control number 0910-0786.

Section 314.65 states that the sponsor must notify FDA when withdrawing an unapproved application.

Sections 314.70 and 314.71 require that supplements be submitted to FDA for certain changes to an approved application.

Section 314.72 requires sponsors to report to FDA any transfer of ownership of an application.

Section 314.80(c)(1) and (2) set forth requirements for expedited adverse drug experience postmarketing reports and followup reports, as well as for periodic adverse drug experience postmarketing reports (Form FDA 3500A).

Section 314.80(i) establishes recordkeeping requirements for reports of postmarketing adverse drug experiences. The burden hours for § 314.80(i) are approved under OMB control numbers 0910-0230 (Adverse Drug Experience Reporting) and 0910-0291 (MedWatch: FDA's Medical Reporting Program), and therefore burden estimates are not included in table 1.

Section 314.81(b)(1) requires that NDA and ANDA field alert reports be submitted to FDA (Forms FDA 3331 and Form FDA 3331a).

Section 314.81(b)(2) requires that annual reports be submitted to FDA (Form FDA 2252).

Section 314.81(b)(3)(i) requires that drug advertisements and promotional labeling be submitted to FDA (Form FDA 2253).

Section 314.81(b)(3)(iii) sets forth reporting requirements for sponsors who withdraw an approved drug product from sale. The burden hours for § 314.81(b)(3)(iii) are approved under OMB control number 0910-0045 (Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution), and therefore are not included in table 1.

Section 314.90 sets forth requirements for sponsors who request waivers from FDA for compliance with §§ 314.50 through 314.81. The information collection burden estimate for NDA waiver requests is included in table 1 under the estimates for each section that is in part 314, subpart B.

Section 314.93 sets forth requirements for submitting a suitability petition to request a change from a listed drug in accordance with § 10.20 (21 CFR 10.20) and § 10.30. The burden hours for § 314.93 are approved under OMB control number 0910-0191 (Administrative Practices and Procedures; Formal Evidentiary Public Hearing) and are not included in table 1.

Section 314.94(a) through (d) require that an ANDA contain the following information: Application form; table of contents; basis for ANDA submission; conditions of use; active ingredients; route of administration, dosage form, and strength; bioequivalence; labeling; chemistry, manufacturing, and controls; samples; and patent certification.

Section 314.95 requires that any notice of certification of invalidity or non-infringement of a patent to each patent owner and the NDA holder be sent by ANDA applicants.

Section 314.96 sets forth requirements for amendments to an unapproved ANDA.

Section 314.97 sets forth requirements for submitting supplements to an approved ANDA for certain changes to the application. Approval of burden hours for information collections for §§ 314.95 through 314.97 are covered under OMB control number 0910-0786.

Section 314.98(a) sets forth postmarketing adverse drug experience reporting and recordkeeping requirements for ANDAs. The burden hours for § 314.98(a) are approved under OMB control numbers 0910-0230 and 0910-0291 and are not included in table 1 of this document.

Section 314.98(b) requires other postmarketing reports for ANDAs: Field alert reports (Form FDA 3331a), annual reports (Form FDA 2252), and advertisements and promotional labeling (Form FDA 2253). (The information collection burden estimate for field alert reports is included in table 1 of this document under § 314.81(b)(1); the estimate for annual reports is included under § 314.81(b)(2); the estimate for advertisements and promotional labeling is included under § 314.81(b)(3)(i).)

Section 314.99(a) requires that sponsors comply with certain reporting requirements for withdrawing an unapproved ANDA and for a change in ownership of an ANDA.

Section 314.99(b) sets forth requirements for sponsors who request waivers from FDA for compliance with §§ 314.92 through 314.99. (The information collection burden estimate for ANDA waiver requests is included in table 1 of this document under the estimates for each section that is in part 314, subpart C.)

Section 314.101(a) states that if FDA refuses to file an application, the applicant may request an informal conference with FDA and request that the application be filed over protest.

Section 314.102 covers communications between FDA and applicants, including requests for meetings.

Section 314.103 covers specified dispute resolution. To assist respondents with certain aspects of this requirement, we have issued draft guidance entitled “Requests for Reconsideration at the Division Level Under GDUFA [the Generic Drug User Fee Act]; Guidance for Industry.”

Section 314.107(c) requires notice to FDA by the first applicant to submit a substantially complete ANDA containing a certification that a relevant patent is invalid, unenforceable, or will not be infringed of the date of first commercial marketing. The burden estimate for § 314.107(c) is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (l).

Section 314.107(e) requires that an applicant submit a copy of the entry of the order or judgment to FDA within 10 working days of a final judgment. The burden estimate for § 314.107(e) applications is included in table 1 under the estimates for § 314.50(a) through (g) and (i) through (l) and is approved under OMB control number 0910-0786.

Section 314.107(f) requires that ANDA or section 505(b)(2) applicants notify FDA immediately of the filing of any legal action filed within 45 days of receipt of the notice of certification. A patent owner must also notify FDA of the filing of any legal action for patent infringement. If the patent owner or approved application holder who is an exclusive patent licensee waives its opportunity to file a legal action for patent infringement within the 45-day period, the patent owner or approved application holder may submit to FDA a waiver in the specified format. The burden estimate for § 314.107(f) is included in table 1 under the estimates for § 314.50 (a) through (g) and (i) through (l) and is approved under OMB control number 0910-0786.

Section 314.110(b)(3) states that, after receipt of an FDA complete response letter, an applicant must either: (1) Resubmit the application addressing all the deficiencies identified in the complete response letter; (2) withdraw the application; or (3) request an opportunity for a hearing on the question of whether there are grounds for denying approval of the application. The burden hours for § 314.110(b)(3) are included under parts 10 through 16 (21 CFR parts 10 through 16, OMB control number 0910-0191) hearing regulations, in accordance with § 314.201, and are not included in table 1.

Section 314.122(a) requires that an ANDA or a suitability petition that relies on a listed drug that has been voluntarily withdrawn from sale must be accompanied by a petition seeking a determination whether the drug was withdrawn for safety or effectiveness reasons. The burden hours for § 314.122(a) are approved under OMB control number 0910-0191 and therefore are not included in table 1.

Section 314.122(d) sets forth requirements for relisting petitions for unlisted discontinued products. The burden hours for § 314.122(d) are approved under OMB control number 0910-0191 and therefore are not included in table 1.

Sections 314.125 and 314.127 state that FDA may refuse to approve an NDA or an ANDA and will provide the applicant written notice of an opportunity for a hearing under § 314.200 along with the reason for refusal to approve the application, including lack of a patent certification or statement with respect to each listed patent for an approved drug product that is pharmaceutically equivalent to the drug product for which the original 505(b)(2) application is submitted and was approved before the original 505(b)(2) was submitted. The burden hours for §§ 314.125 and 314.127 (refuse to approve an ANDA) are included under parts 10 through 16 hearing regulations (in accordance with § 314.201) and approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.126(c) sets forth requirements for a petition to waive criteria for adequate and well-controlled studies. The burden hours for § 314.126(c) are approved under OMB control number 0910-0191 and therefore are not included in table 1.

Sections 314.150(a) and (b) and 314.151(a) and (b) set forth requirements for the withdrawal of approval of an NDA or ANDA and the applicant's opportunity for a hearing and submission of comments. The burden hours for § 314.151(a) and (b) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, and approved under OMB control number 0910-0191 and therefore are not included in table 1.

Section 314.151(c) sets forth the requirements for withdrawal of approval of an ANDA and the applicant's opportunity to submit written objections and participate in a limited oral hearing. The burden hours for § 314.151(c) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.153(b) sets forth the requirements for suspension of an ANDA when the listed drug is voluntarily withdrawn for safety and effectiveness reasons, and the applicant's opportunity to present comments and participate in a limited oral hearing. The burden hours for § 314.152(b) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.161(b) and (e) sets forth the requirements for submitting a petition to determine whether a listed drug was voluntarily withdrawn from sale for safety or effectiveness reasons. The burden hours for § 314.161(b) and (e) are approved under OMB control number 0910-0191 and therefore are not included in table 1.

Section 314.200(c), (d), and (e) requires that applicants or others subject to a notice of opportunity for a hearing who wish to participate in a hearing file a written notice of participation and request for a hearing as well as the studies, data, and so forth, relied on. Other interested persons may also submit comments on the notice. This section also sets forth the content and format requirements for the applicants' submission in response to notice of opportunity for hearing. The burden hours for § 314.200(c), (d), and (e) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.200(f) states that participants in a hearing may make a motion to the presiding officer for the inclusion of certain issues in the hearing. The burden hours for § 314.200(f) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.200(g) states that a person who responds to a proposed order from FDA denying a request for a hearing provide sufficient data, information, and analysis to demonstrate that there is a genuine and substantial issue of fact, which justifies a hearing. The burden hours for § 314.200(g) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.420 states that an applicant may submit to FDA a drug master file in support of an application, in accordance with certain content and format requirements.

Section 314.430 states that data and information in an application are disclosable under certain conditions, unless the applicant shows that extraordinary circumstances exist. The burden hours for § 314.430 are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.530(c) and (e) states that if FDA withdraws approval of a drug approved under the accelerated approval procedures, the applicant has the opportunity to request a hearing and submit data and information. The burden hours for § 314.530(c) and (e) are included under parts 10 through 16 hearing regulations, in accordance with § 314.201, are approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.530(f) requires that an applicant first submit a petition for stay of action before requesting an order from a court for a stay of action pending review. The burden hours for § 314.530(f) are approved under OMB control number 0910-0191, and therefore are not included in table 1.

Section 314.550 requires an applicant with a new drug product being considered for accelerated approval to submit copies of all promotional materials to FDA during the preapproval and post-approval periods.

Section 314.610(b)(1) requires that applicants include a plan or approach to postmarketing study commitments in applications for approval of new drugs when human efficacy studies are not ethical or feasible, and provide status reports of postmarketing study commitments. The burden estimate for § 314.610(b)(1) is included in table 1 under the estimates for §§ 314.50(a) through (f), (k), and (l); and 314.81(b)(2)).

Section 314.610(b)(3) requires that applicants propose labeling to be provided to patient recipients in applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden estimate for § 314.610(b)(3) is included in table 1 under the estimates for § 314.50(e).

Section 314.630 requires that applicants provide postmarketing safety reporting for applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden hours for § 314.630 are approved under OMB control numbers 0910-0230 and 0910-0291, and therefore not included in table 1.

Section 314.640 requires that applicants provide promotional materials for applications for approval of new drugs when human efficacy studies are not ethical or feasible. The burden estimate for §  314.640 is included in table 1 under the estimates for §  314.81(b)(3)(i)).

In the Federal Register of May 26, 2017 (82 FR 24351), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the four information collection topics solicited in the notice. However, one comment was received regarding NDA submission criteria, and we have directed the comment to the appropriate Agency component for consideration.

Accordingly, we estimate the burden for this collection of information as follows:

We retain the currently approved burden estimate for the information collection associated with the provisions identified above. At the same time, we have added burden estimate associated with § 314.103, although in an effort to reduce burden, we have issued associated guidance to assist respondents with the relevant information collection.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports the reporting associated with the submission of petitions and notifications seeking exemptions from the labeling requirements for ingredients derived from major food allergens, and the Agency's associated guidance document.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II, Pub. L. 108-282) amended the FD&C Act by defining the term “major food allergen” and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived. Section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)) sets forth the requirements for declaring the presence of each major food allergen on the product label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a major food allergen as “[m]ilk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans” and also as a food ingredient that contains protein derived from such foods. The definition excludes any highly refined oil derived from a major food allergen and any ingredient derived from such highly refined oil.

In some cases, the production of an ingredient derived from a major food allergen may alter or eliminate the allergenic proteins in that derived ingredient to such an extent that it does not contain allergenic protein. In addition, a major food allergen may be used as an ingredient or as a component of an ingredient such that the level of allergenic protein in finished food products does not cause an allergic response that poses a risk to human health. Therefore, FALCPA provides two mechanisms through which such ingredients may become exempt from the labeling requirement of section 403(w)(1) of the FD&C Act. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).

The labeling requirements of section 403(w)(1) of the FD&C Act apply to all packaged foods sold in the United States that are regulated under the FD&C Act, including both domestically manufactured and imported foods. As noted, section 403(w)(1) of the FD&C Act requires that the label of a food product declare the presence of each major food allergen. We estimate the information collection burden of the third-party disclosure associated with food allergen labeling under section 403(w)(1) of the FD&C Act as the time needed for a manufacturer to review the labels of new or reformulated products for compliance with the requirements of section 403(w)(1) of the FD&C Act and the time needed to make any needed modifications to the labels of those products. The allergen information disclosed on the label or labeling of a food product benefits consumers who purchases that food product. Because even small exposure to a food allergen can potentially cause an adverse reaction, consumers use food labeling information to help determine their product choices.

FDA estimates the third-party disclosure burden of the collection of information as follows:

We have retained the currently approved burden estimate associated with the information collection. Based on our experience with the information collection since it was established 3 years ago, we estimate that there are approximately 690,000 Universal Product Codes (UPCs) of FDA-regulated foods and approximately 85,000 UPCs of FDA-regulated dietary supplements for a total of 775,000 UPCs (Ref. 1). Using the labeling cost model, we estimate the entry rate of new UPCs to be 8 percent per year. Based on the entry rate of new UPCs, we estimate the rate of new or reformulated UPCs to be approximately 10 percent per year, or 77,500 products (775,000 × 10 percent). Thus, we estimate that, annually, 77,500 new or reformulated products are sold in the United States. Assuming an association of one respondent to each of the 77,500 new or reformulated products, we estimate that 77,500 respondents will each review the label of one of the 77,500 new or reformulated products. We estimate an average of 1 hour for the review of labels for compliance with the food allergen labeling requirements under section 403(w)(1) of the FD&C Act, for a total of 77,500 hours annually, as reflected in table 1, row 1.

We have no data on how many label reviews would identify the need to redesign the label. For purposes of this analysis, therefore, we estimate 5 percent, or 3,875 labels (77,500 × 5 percent) will be redesigned to comply with the requirements of section 403(w)(1) of the FD&C Act. Assuming an association of one respondent to each of the 3,875 redesigned labels and averaging 16 hours to complete the label redesign, we estimate a total of 62,000 hours annually for this activity, as reflected in table 1, row 2.

Under sections 403(w)(6) and (7) of the FD&C Act, respondents may request from us a determination that an ingredient is exempt from the labeling requirement of section 403(w)(1) of the FD&C Act. An ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(6) of the FD&C Act). This section also states that “the burden shall be on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.” Alternately, an ingredient may become exempt through submission of a notification containing scientific evidence showing that the ingredient “does not contain allergenic protein” or that there has been a previous determination through a premarket approval process under section 409 of the FD&C Act that the ingredient “does not cause an allergic response that poses a risk to human health” (section 403(w)(7) of the FD&C Act).

The guidance document entitled, “Food Allergen Labeling Exemption Petitions and Notifications: Guidance for Industry,” sets forth our recommendations with regard to the information that respondents should submit in such a petition or notification. The guidance states that to evaluate these petitions and notifications, we will consider scientific evidence that describes: (1) The identity or composition of the ingredient; (2) the methods used to produce the ingredient; (3) the methods used to characterize the ingredient; (4) the intended use of the ingredient in food; and (5) either (a) for a petition—data and information, including the expected level of consumer exposure to the ingredient, that demonstrate that the ingredient, when manufactured and used as described, does not cause an allergic response that poses a risk to human health; or (b) for a notification, data and information that demonstrate that the ingredient, when manufactured as described, does not contain allergenic protein, or documentation of a previous determination under a process under section 409 of the FD&C Act that the ingredient does not cause an allergic response that poses a risk to human health. We use the information submitted in the petition or notification to determine whether the ingredient satisfies the criteria of section 403(w)(6) and (7) of the FD&C Act for granting the exemption.

We estimate the reporting burden associated with the collection of information as follows:

I. Background

We are announcing the availability of a draft guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. The guidance is not subject to Executive Order 12866.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the FD&C Act to expand and enhance our ability to ensure that imported food products meet U.S. standards and are safe for consumers. Among the FSMA changes to the FD&C Act, we now must refuse admission of a food into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary of Health and Human Services, upon request, to inspect such factory, warehouse, or other establishment (section 807(b) of the FD&C Act (21 U.S.C. 384c(b))). In addition, the FD&C Act, at section 807(b), states that an owner, operator, or agent in charge is considered to have refused an inspection if the owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after we submit an inspection request, or after such other time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment.

This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in section 807(b) of the FD&C Act.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Under the FD&C Act and implementing regulations, promotional labeling and advertising about prescription drugs are generally required to be truthful, non-misleading, and to reveal facts material to the presentations made about the product being promoted (see FD&C Act sections 201(n) and 502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR 202.1).

Prescription drug promotion sometimes includes false or misleading (collectively, deceptive 1 ) claims, images, or other presentations; for instance, representations that a drug is more effective or less risky than is demonstrated by appropriate evidence. A number of empirical studies have examined the occurrence and influence of deceptive promotion, both in regard to prescription drugs (Refs. 1 and 2) and other products (Refs. 3 and 4). No research to our knowledge, however, has investigated the ability of consumers and healthcare professionals (HCPs) to independently identify deceptive prescription drug promotion.

The ability of consumers and HCPs to identify deceptive prescription drug promotion has important public health implications. If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe. On the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action.

Reports of deceptive promotion are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to review everything. The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug promotion (Ref. 5), a goal which requires that HCPs successfully identify such promotion when it appears in the course of their duties. Likewise, similar programs could be implemented for consumers to report deceptive prescription drug promotion to FDA.

The mission of the Office of Prescription Drug Promotion (OPDP) within FDA is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, and to guard against deceptive promotion through comprehensive surveillance, enforcement, and educational programs. As part of this mission, it is critical that OPDP adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations' processing of such claims. This understanding will help OPDP to identify best practices for addressing false and misleading claims in prescription drug promotion. The research described here will provide evidence to inform consideration of the approaches best suited to fulfill OPDP's mission to protect the public from deceptive promotion.

The proposed project involves two studies examining volunteer participants' ability to detect and report deceptive presentations in prescription drug promotion. The studies will be conducted concurrently and will focus on different health conditions. Each study will be administered to two separate populations (i.e., HCPs and consumers affected by the condition). HCPs will view mock pharmaceutical websites targeted toward physicians and consumers will view mock consumer-targeted pharmaceutical websites. The goal will be to keep the HCP and consumer-targeted websites as similar as possible, but to include content that is appropriate for the target audience. For example, HCP websites may contain medical terminology, whereas the consumer websites would utilize consumer friendly language. A professional firm will create all mock websites such that they are generally indistinguishable from currently available prescription drug websites.

Study 1 and 2 sample. Study 1 will sample consumers who self-report chronic pain that has lasted at least 3 months and HCPs whose primary medical specialty is either primary care or internal medicine and whose responsibilities involve direct patient care at least 50 percent of the time. Chronic pain has an incidence rate of roughly 11 percent (Ref. 6) in the population. Study 2 will sample consumers who self-report obesity, defined as body mass index greater than or equal to 30 (35 percent incidence; Ref. 7) and include the same types of HCPs as study 1. For both consumers and HCPs, pretest participants will not be eligible for the main study.

Pretesting. Pretesting will take place before the main studies to evaluate the procedures and measures used in the main studies. Each of the two pretests will have the same design as its respective main study (pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both pretests will be to: (1) Ensure that the mock websites are understandable, viewable, and delivering intended messages; (2) identify and eliminate any challenges to embedding the mock websites within the online survey; (3) ensure that survey questions are appropriate and meet the analytical goals of the research; and (4) pilot test the methods, including examining response rates and timing of survey. The two pretests will be conducted simultaneously. Based on pretest findings, we will refine the mock websites, survey questions, and data collection process, as necessary, to optimize the full-scale study conditions.

Main studies. The proposed design for the main studies, including sample sizes, is summarized below and described next.

The purpose of Study 1 is to assess consumer and HCP response to promotional websites with varying levels of false or misleading presentations. In Study 1, degree of deception will be manipulated over three levels by altering the number of deceptive claims (none, fewer, more). It is possible that consumers and HCPs are only able to identify ads as deceptive when they include a greater number of violations, whereas ads with few violations may not be identified as deceptive. The experimental stimuli will be in the form of a web page for a fictitious drug targeted toward consumers who have chronic pain or toward HCPs. The deceptive websites will contain various types of violations. The website with fewer violations will contain a subset of the deceptive claims, imagery, or other presentations included in the website with more violations. For example, if the fewer-violations website includes two violations, then the more-violations website will include the same two violations plus two or three additional violations (in the form of claims and/or graphics).

Study 1 will help FDA address several key questions:

• What proportion of consumers and HCPs correctly identify a promotional piece as deceptive? Does the ability to identify deceptive promotion vary depending on the number of deceptive claims in a promotional piece?

• Does the degree of deception affect consumers' and HCPs' attitudes and behavioral intentions toward the promoted drug, including intended reporting to regulatory authorities?

• Is the effect of deceptive promotional pieces mediated by a person's ability to identify a promotional piece as deceptive (that is, do people who recognize a piece as deceptive discount the information in the piece, thereby adjusting their attitudes and intentions toward the product)?

Whereas Study 1 focuses on the level of deception (based solely on the number of false or misleading claims), Study 2 focuses on the type of deception (implicit versus explicit). Many deceptive promotional claims are implicit rather than being explicitly false (Refs. 1 and 4). An implicit claim suggests or implies an unstated piece of information. An explicit claim fully and clearly expresses information and leaves nothing to be implied. Study 2 will compare perceptions and beliefs that consumers and HCPs hold about a drug following exposure to one of three versions of a prescription drug website: (1) An explicitly false website, (2) a factually true but implicitly misleading website, or (3) a website with no deceptive claims (the control group).

As with Study 1, we envision a pair of one-way factorial experiments, one conducted with a sample of consumers and the other with HCPs. Similar to Study 1, Study 2 will investigate how misleading implicit claims and explicitly false claims in prescription drug promotional pieces influence a person's ability to detect and respond appropriately to deception. The experimental stimuli will be in the form of a mockup of a pharmaceutical website targeted toward the relevant experimental population, obese consumers or HCPs who treat obese patients. As with study 1, the drug profile, including indication, risks, and logo branding will be fictitious. For the implicit misleading claim manipulations, we are interested in whether people infer false beliefs from the implicit communications.

Study 2 will help FDA address several key questions:

• What proportion of consumers and HCPs correctly identify a promotional piece as deceptive? Does the ability to identify deceptive promotion vary depending on whether deceptive claims in a promotional piece are explicit versus implicit?

• Does the type of deception affect consumers' and HCPs' attitudes and behavioral intentions toward the promoted drug, including intended reporting to regulatory authorities?

• Is the effect of deceptive promotional pieces mediated by a person's ability to identify a promotional piece as deceptive (that is, do people who recognize a piece as deceptive discount the information in the piece, thereby adjusting their attitudes and intentions toward the product)?

Measurement. Identifying how to measure consumers' and HCPs' ability to identify deceptive promotion as well as their reaction to such promotion is fundamental to achieving the research goals. A literature review revealed the importance of using a variety of measures to capture detection of deception. For direct measures, we will incorporate questions that ask participants to indicate whether there was any deception in the promotional piece and to rate the promotional piece in terms of how deceptive, credible, or trustworthy it was. Additionally, we will include claim-specific direct measures that allow people to click on any part of the website that they deem deceptive. Using responses to this variable, we can assess whether participants think there is any deception in a promotional piece; in instances where they do think there is deception, we can assess what aspects of the website contributed to that belief. We will also include indirect measures that identify whether participants believed the website expressed particular claims (e.g., claim recognition) as well as participants' beliefs about the veracity of any deceptive claims (e.g., claim truth, agreement, or acceptance). Moreover, we will assess whether participants believe the messages merit reporting to regulatory authorities (that is, FDA). To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. A copy of the draft questionnaire is available upon request.

In the Federal Register of January 4, 2017 (82 FR 855), FDA published a 60-day notice requesting public comment on the proposed collection of information. Comments received along with our responses to the comments are provided below. Comments that are not PRA-relevant or do not relate to the proposed study are not included. For brevity, some public comments are paraphrased and therefore may not reflect the exact language used by the commenter. We assure commenters that the entirety of their comments was considered even if not fully captured by our paraphrasing. Question numbering here (e.g., Q30) reflects numbering from the original draft questionnaire, shared by request at the time of the 60-day notice. The following acronyms are used here: FRN = Federal Register Notice; DTC = direct-to-consumer; HCP = healthcare professional; FDA and “The Agency” = Food and Drug Administration; OPDP = FDA's Office of Prescription Drug Promotion.

(Comment 1) regulations.gov tracking number 1k1-8ubr-t0de (verbatim with header and footer language removed):

We are supportive of the study, but have the following recommendations.

We propose that additional study arms be included that explore various scenarios/websites which test both the number of deceptive claims in conjunction with the degree of deception. Currently, the study is structured to measure the impact of the number of deceptions in a promotional website (Study 1) separately from the degree of the deception (explicit vs implicit, in Study 2). However, it would also be beneficial to measure other combinations to see which factor or combination of factors had the greatest impact on HCPs and Consumers' overall perception of the website. For example, a single explicit lie may be more impactful than 15 implied deceptions. The current study will not be able to draw any conclusions regarding that scenario. Testing additional combinations of the number of deceptions in a website along with deceptive claims of varying severity would enable a better comparison and understanding of what ultimately drives HCPs and Consumers' perception of deceptive prescription promotion.

(Response) We thank the commenter for their support and for this suggestion. While certainly a viable research idea, cost implications of creating and testing additional stimuli for this purpose bar us from pursuing it. We encourage researchers to pursue this idea in future research.

(Comment 2) regulations.gov tracking number 1k1-8v15-11b6 (some comments summarized for brevity; others provided verbatim):

a. Given the stated purpose of the pretests, sample size can be substantially reduced, and revised to a qualitative approach.

(Response) In addition to the quantitative pretest, we have already conducted a qualitative test of stimuli and questionnaire materials via cognitive interviews. Changes based on cognitive interviews are reflected in our updated survey materials. In regard to sample size, the number of pretest participants per experimental condition (n = 50) was chosen based on a power analysis, and is considered to be the minimum effective size to allow for assessment of the quantitative outcomes specified in the 60-day FRN. Examples of quantitative outcomes include assessment of response rates and timing of the survey.

b. To reduce bias, add a screening question to exclude respondents who are opposed to taking prescription medicines.

(Response) The survey length does not allow for a full exploration of attitudes toward prescription drug use. However, to assess opposition to prescription drug use more generally, we added one item to the survey that has been used successfully in previous FDA surveys. This item will be used in the pretest survey as a potential covariate and may or may not be retained in the main study survey depending on its performance.

The item reads: “In what situations would you consider taking prescription drugs?”

• I would never take them.

• I would take them only for serious health conditions.

• I would take them for moderate and serious health conditions.

• I would take them for most health conditions, including minor problems.

c. Consider revising item scales to include a mid-point to allow respondents to express neutral views (unless objective is to force a selection).

(Response) Given the focus of the questions, we believe that offering a neutral response option is not necessary to measure opinions and attitudes accurately. Consequently, our objective is to force a selection and have participants make at least a weak commitment in either a positive or negative direction. Of concern is that offering a neutral midpoint could potentially encourage “satisficing”—cuing participants to choose a neutral response because it is offered (Ref. 8). Additionally, providing a midpoint leads to the loss of information regarding the direction in which people lean (Ref. 9). Research has found that neither format (either with or without a neutral point) is necessarily better or produces more valid or reliable results (Ref. 10). Instead, it should be left to the researcher to determine the goals of the study. During cognitive testing, a majority of participants were satisfied with the response options and all participants felt comfortable choosing a response in the absence of a midpoint. Use of a midpoint is an issue we have examined in previous studies and we determined that we achieve valid and reliable responses without a midpoint. To increase consistency with measures used in previous studies, and in support of the arguments presented above, we are opting to exclude a midpoint. Finally, if a participant does not feel that they can choose a response because of a lack of a neutral option, they will be able to skip the question.

d. In Study 1, remove Q21 and Q30 due to potentially leading nature of items.

(Response) To avoid redundancy, we dropped Q21. In Q30, we ask participants to click on anything they think is misleading, and we note that if they do not think anything is misleading, they can click “none.” Consequently, we are not strongly presupposing there are misleading claims. To address some of the wording concerns for this item, we changed the question to ask about inaccurate information instead of misleading information and we moved the “None” response to be more prominent above the image.

(Comment 3) regulations.gov tracking number 1k1-8v3z-nzst (summarized for brevity):

The commenter expresses concern about the practical utility of the research, reasons for which are covered by comments 3a through 3e. In the case that FDA continues with the research, the commenter makes several recommendations which are covered by comments 3f through 3cc. Comments 3f through 3h concern the study stimuli, comment 3i pertains to subject recruitment, and comments 3j through 3cc concern the study questionnaires.

a. The identification of deceptive promotion is FDA's assigned responsibility, not the duty of HCPs and consumers.

(Response) As discussed above, the mission of OPDP within FDA is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, and to guard against false and misleading promotion through comprehensive surveillance, enforcement, and educational programs. As part of this mission, it is critical that OPDP adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations' processing of such claims. This understanding will help FDA/OPDP to identify best practices for addressing deceptive claims in prescription drug promotion. Moreover, we note that sponsors are not generally required to submit promotional pieces to FDA prior to dissemination, and limited resources prevent OPDP from reviewing all promotional materials in the marketplace. Voluntary HCP and consumer reporting of false and misleading promotional pieces contribute to the accomplishment of FDA/OPDP's mission.

b. Deceptive drug promotion is not a prevalent issue that requires further studying.

(Response) Numerous studies have examined the prevalence of false or misleading claims and presentations in DTC advertising, and FDA frequently issues compliance letters addressing false and misleading claims and presentations (Refs. 1 and 2). Consequently, FDA disagrees with this assertion.

c. FDA's proposed studies fail to acknowledge the role of the HCP as the “learned intermediary.”

(Response) The present research takes into consideration both consumer and HCP responses to false or misleading promotion. Consumers often wish to participate in shared decision making with HCPs when selecting prescription drugs and may request specific prescription drugs from their HCPs based on promotions they have seen in the marketplace. Because information consumers receive through DTC prescription drug promotion can impact these requests, it is important to investigate consumers' ability to assess prescription drug product efficacy and risks as conveyed in promotional pieces. And although HCPs have medical training and clinical expertise, we are not aware of research that investigates whether such training and expertise translates into an ability to detect false or misleading promotion in the marketplace. Consequently, the present research investigates both consumer and HCP ability to identify and discount deceptive prescription drug promotion.

d. The proposed studies are duplicative of recent FDA research concerning HCP willingness to report deceptive promotion.

The commenter suggests that if FDA wishes to investigate consumer reporting, the Agency should create two separate studies. The first should gauge consumer aptitude in identifying false or misleading prescription drug promotion. Depending on the results of the first study, the Agency could potentially undertake a second study, surveying subject willingness to report false or misleading drug promotion. This approach would avoid potential error associated with influence of earlier questions regarding deception on later questions regarding reporting.

(Response) FDA conducted a survey of HCPs in 2013 in which respondents were asked about their familiarity with the Bad Ad program and willingness to report misleading advertising (Ref. 5). The current study is quite different in scope from the previous research. The current study consists of an experimental design that will enable us to determine whether HCPs can detect misleading advertising, not just whether they are willing to report it. We do include questions at the end of the survey asking similar questions as those in the 2013 survey, but the purpose here is in connection to HCP ability to detect misleading advertising. Moreover, our use of similar questions here reflects a well-established technique in scientific research, used to determine whether previous findings can be replicated or not.

In response to the second comment recommending division of this project into two separate studies, we believe that proposal to be an inefficient use of resources. Regarding concerns about the order of questions affecting subsequent responses, we chose to distribute deception-related items throughout the survey, rather than ask all deception items first and then other outcome measures second. Also, we include “masking” items on the same screen as deception-related items to mask the intent of the questions. The results from cognitive interviews confirm that this approach was successful. Consequently, we have no evidence to suggest that earlier questions related to deception will influence subsequent questions related to reporting.

e. FDA already has created and implemented consumer programs to report deceptive promotion.

(Response) The proposed research can inform program needs at present, whether such needs involve reevaluation of past programs such as EthicAd, or extensions of existing programs such as the Bad Ad program or other actions.

f. Validating Stimuli. It is not clear how the Agency will determine that a study stimulus is deceptive. FDA notes in the PRA Notice that the “term deceptive is not meant to imply equivalence (or lack thereof) with use of the same term by the U.S. Federal Trade Commission.” It seems unrealistic for FDA to conduct research with primary care physicians (PCPs) and consumers who do not understand the Agency's standards or have access to the training and resources of an FDA reviewer.

Further, except for literal falsity, whether a particular communication is false or misleading must be based on empirical evidence. Promotional pieces do not exist in a vacuum. These communications interact with the overall health information ecosystem, including the internet. FDA needs to first validate that the study stimuli are indeed deceptive before including the stimuli in either proposed study with the presumption that they are deceptive.

(Response) Our reference to the Federal Trade Commission's (FTC) definition of the term “deceptive” was offered as a point of clarification for our use of the same term as shorthand within the FRN for the longer phrase “false or misleading.” In other words, by using “deceptive” as a term of art in this narrow context, we are not evoking the specific meaning and interpretation of the same term used by the FTC.

We disagree with the suggestion that participants need to have access to the training and resources of an FDA reviewer before FDA can evaluate their ability to identify deceptive promotion. As further explained below, FDA is not asking participants to determine whether nuanced text meets the regulatory standards for deceptive promotion; instead, we are presenting material that meets both the regulatory standard for a deceptive promotion and could be identified as such by consumers or healthcare providers with no prior experience with the regulations.

We agree with the second point about the need to validate that the study stimuli are deceptive, and we are doing this in several ways for this study. For example, some of the specific claims used in our experimental manipulations are established as being factually incorrect because the promoted drug is a member of a class of drugs for which the claim could not be true (e.g., describing a serotonin-norepinephrine reuptake inhibitor (SNRI), which is required to have a black box safety warning for suicide risk, as lacking in significant safety concerns). Other claims or presentations in the stimuli are based on similar claims cited as violative in past warning letters or that unambiguously fail to follow the law (e.g., minimizing presentation of important safety information, such as a black box warning, by setting it in small, low contrast type). For one manipulated claim, we provided participants with access to the background information needed to identify the presentation as deceptive in the form of a footnote. In the case of Study 2, where a crucial aspect of the experimental design is to test an implicitly misleading claim in relation to an explicitly false claim and against a nonviolative control, we tested candidate claims in cognitive interviews to verify that the audience tended to interpret the implicit claims as intended.

Further, it is important to note that we included a control condition in both studies, which will enable us to compare responses to a website that has no violations. The control conditions serve as a baseline for perceived deception, which will also allow us to examine how consumers and providers perceive websites with no violations.

g. Media. The Agency proposes using websites as the only stimuli. FDA should consider testing additional non-electronic media, including DTC and HCP print promotional materials. The Agency should also base the promotional stimuli on realistic “mock” package insert (PI) documents. The commenter requests that FDA make available for public comment these materials.

(Response) Previous research on DTC and HCP-directed prescription drug promotional materials has, to varying extents, included all available media formats, and assessment of outcomes using these formats has proven useful. We agree that investigating recognition of misleading prescription drug information in multiple formats—including print, television, web, and other modes—would be valuable. However, we also recognize that no single study can effectively examine all promotional formats or presentations, and we chose to focus on branded drug websites for several reasons. First, websites, while not necessarily more or less useful than any other format, are arguably quite prevalent and important in today's technological age where a large segment of the consumer population is connected to the internet and known to seek information regarding prescription drugs using the internet. For example, online promotion is the fastest growing category of DTC drug marketing, and branded websites account for the largest share of this category (Ref. 11). Second, almost all print and television ads for prescription drugs encourage viewers to visit branded websites for more information, making these sites an important extension of promotion in other formats (Ref. 12). Third, FDA has issued multiple warning and notice of violation letters for branded drug websites that incorrectly communicate information to visitors, suggesting that there may be a problem with a proportion of such sites presenting misleading information. Fourth, websites serve as a fairly newer format for promotion relative to television and print promotion, and by consequence warrant further study. There has been significantly less research on consumer and provider interpretation of branded drug websites than other promotional formats (Ref. 13), and the extant research suggests that some websites still do not present a fair balance of risk and benefit information (Ref. 14).

Based on these considerations, we believe that focusing this study on branded drug websites will be the most effective use of FDA's limited resources. The fictitious websites included in this study were modeled on real products (including the package insert) to ensure realism and relevance.

In response to the request to share stimuli, we generally do not share stimuli before the study has been conducted to avoid possible inadvertent publication and therefore contamination of the subject pool, which would compromise the research.

h. Disease States. The Agency's two studies propose testing stimuli concerning chronic pain or obesity. The commenter suggests that FDA instead consider testing stimuli featuring a fictitious product for a disease state which involves more complex safety information. Such stimuli would be more reflective of the current healthcare environment, where product labeling is increasingly complex.

(Response) The fictitious websites used in this research do include complex safety information, which reflect the risks for real chronic pain and obesity products in the marketplace. For example, one of the fictitious products includes a black box warning, and the other includes severe and complex safety information, such as potential drug interactions and contraindications.

i. Study 1 Stimuli. In Study 1, the “degree of deception will be manipulated over three levels by altering the number of deceptive claims (none, fewer, more).” FDA states that the deceptive claims will include “various types of violations.” Under the potential design, the most egregious deceptive claim(s) might only be contained in the “more” level. This could potentially skew study results, as subjects would be more likely to identify such egregious claims. FDA should develop a scale that is used to determine the egregiousness of the deception. The scale should include specific examples of egregiousness by category.

(Response) Although some claims do not overlap between the “fewer violations” and “more violations” conditions, we strategically manipulated the stimuli so that one of the more “egregiously” deceptive claims (which appears in a callout bubble) is present in both conditions. There is also overlap in those two conditions for another manipulated element, where we minimized the prominence of the Important Safety Information. Additionally, we included an item (Q30) that would provide participants the opportunity to click on anything they think may be inaccurate. Using this question, we would expect that the more egregious claims will be chosen more often. In this way, this item would serve as a proxy measure of egregiousness. Further, our various questions that ask about perceived deceptiveness of the websites will provide an initial assessment of the degree of deception—with higher scores representing greater perceived deception. Because of space constraints on the survey, we are unable to ask participants to rate the egregiousness of the violative claims. Although we appreciate the value that developing a scale to determine the egregiousness of each of the deceptive claims would add, adopting this suggestion in the present research would be outside of the scope of this study and would have an impact on overall cost considerations.

j. FDA proposes that the HCP samples for both studies will only include physician subjects. The commenter believes the samples should include other types of HCPs, including nurse practitioners, physician assistants, and pharmacists. As the Agency's recent research showed, “Nurse practitioners and physician assistants tended to see the [Bad Ad] program as more useful than [PCPs] and specialists. They also reported a greater likelihood of reporting false or misleading advertising in the future.” Given these findings, it would be helpful also to investigate the ability of other HCPs independently to identify false or misleading promotion.

Additionally, during the recruiting process, FDA should ensure enrollment of a diversity of subjects across demographic categories. Previous research indicates that certain demographic groups respond to drug promotion in different manners. Uneven representation within certain categories could potentially skew study results.

(Response) FDA acknowledges and agrees with the assertion that including other types of HCPs in this research would provide value. Yet, sampling from these additional groups requires funding that may not be justified in this initial investigation of the topic area. Nonetheless, we do intend to strive for diversity in both our HCP and consumer samples. HCPs and consumers will vary in terms of age, race, and ethnicity, and consumers will additionally vary in terms of their education level.

k. Leading Questions. The overall format of the questionnaires is quite leading. As previously mentioned, questions asking whether sample advertisements are “deceptive,” “misleading,” “bad,” and “not believable” could easily pollute data from later questions inquiring whether a subject would potentially report such promotion to FDA. The Agency should state all questions in an objective manner.

(Response) Leading questions are those that “suggest a possible answer or make some responses seem more acceptable than others” (Ref. 15). In keeping with standard practice for balancing the valence of attitudinal questions, we have included a mix of positive and negative statements in the questionnaire. In fact, there are presently more positively framed items than negatively framed items. Moreover, the slider questions referenced by the commenter are semantic differentials, which show both a negatively framed word and its positive counterpart on opposite ends of the response scale (e.g., “deceptive/truthful,” “misleading/accurate,” “not believable/believable”). We do not see how these items could be construed as leading because both the positive and negative frames are presented. Finally, as stated in our response to Comment 3d, we have evidence to suggest that we successfully masked the true focus of the questionnaire, so the deception-focused items should not bias subsequent responses.

l. Recall Questions. Certain questions (e.g., Q1-Q3 of Study 1, Q4 of Study 2) ask test subjects to recall specific risks and side effects of the featured drug products. Such questions are not valid instruments to assess whether a subject perceives a stimulus to be false or misleading. Recall is likely influenced by the presentation of the content (e.g., size, visual display), not by the content itself. This research, however, is not material to the stated purpose of the studies. The recall questions should be omitted from the questionnaires.

(Response) Q1-Q2 of Study 1 measure risk recall and risk recognition. These are important outcome measures for our study because we vary how the risks are presented in the different experimental conditions, minimizing them (in terms of size and format) in the violative conditions. Including these risk recall and recognition measures allow us to test whether minimizing the risks influences participants' ability to remember them. Further, because minimization of risk is a misleading violation in its own right, reduced risk recall or recognition among participants in the violative conditions would provide relevant context for interpreting more direct measures of deception. Q4 of Study 2 will enable us to determine if participants can recall seeing the disclosure statements in the websites. This is relevant to the question of whether participants identify false or misleading content because the disclosure statement provides information that would help participants assess the truth of the headline claim. None of these items are intended to be direct measures of whether the stimuli are misleading; instead, they are outcomes that may be affected by misleading content.

m. Repetitive Questions. The questionnaires are repetitive in nature. For example, in Q4-Q11 of Study 1, subjects are asked a series of eight questions to measure “Perceived Website Deception.” The questions are redundant (e.g., Believable/Not believable, Truthful/Deceptive, Factual/Distorted, Accurate/Misleading). This duplication may cause the subject to believe the promotional material is actually false or misleading.

(Response) The use of multiple items to tap into a singular construct is considered a best practice in social science research, particularly when assessing complex psychological constructs like those in this survey. Our intent is to combine responses to these items into a single composite score. Our cognitive interviewing of these items suggests that they have slightly different meanings for many participants and thus are not viewed as completely redundant. Further, there is no evidence to suggest that the use of multiple items to assess this construct led participants to believe that the promotional material was actually false or misleading or that this series of questions was designed to capture whether they thought the website was misleading. Consequently, we successfully masked the true intent of this item by including other bipolar response options unrelated to misleadingness.

We dropped Q21 to reduce redundancy across items.

n. Definitions and Terms. The questionnaires do not define certain key terms (e.g., effectiveness, risk, misleading). Subjects, especially consumers, may interpret these terms based on different standards. FDA might consider providing user-friendly definitions for the consumer subjects. The Agency should also utilize patient-friendly medical terms, rather than complex terminology (e.g., glaucoma, hepatic failure, SNRI).

(Response) Sophisticated medical terminology will only be used in the HCP survey. To use the example of “hepatic failure,” consumers will instead see “decreased liver function.” We have verified in cognitive interviews that preceded this study (and in our previous scale development efforts) that the terminology used is generally well understood by our participant sample.

o. Sliding Scale Format. FDA should consider replacing the sliding scale format with a “Yes-No-I Don't Know” scheme. The sliding-scale format is at times confusing in form and could potentially introduce error. Alternatively, the Agency should consider changing the sliding scale to an odd number system to permit a “neutral” response and/or use a variation of the Likert scale.

(Response) Use of a sliding scale allows for greater precision and variation in response, as opposed to a “Yes-No-Don't Know” format. Research suggests that scales with five to seven points are more valid and reliable than those with only two to three categories (Ref. 16). Additionally, we tested the sliding-scale format in previous cognitive interviews and found that it worked well; participants had little difficulty understanding this format. Further, as noted in the response to Comment 2c, we want to avoid leading participants to choose a “Don't know” response; providing this option may cue participants to select this response and avoid deeper thinking on the topic. Regarding the use of an even numbered scale rather than odd numbered scale, please see our response to Comment 2c.

p. An “FDA employee” category should be added to Question S2 [Consumer] of Study 1. These individuals should also be terminated from the study.

(Response) Consistent with previous surveys, we added a category to exclude employees of the Department of Health and Human Services, which includes employees of FDA.

q. Question S3 [Consumer] of Study 1 should be rewritten as follows: “Have you ever been diagnosed with chronic or long-lasting pain (more than aches and pains that go away quickly or are minor)?” (emphasis added). This change aligns the question with the description of the study in the PRA Notice: “Study 1 will sample consumers with diagnosed chronic pain that has lasted at least 3 months.”

(Response) We did not restrict people to be diagnosed with chronic pain because the prevalence was too small, which would increase the costs of the study. Using our current screening questions, we achieve an 11 percent prevalence rate (Ref. 6). The objective of our sampling plan is to target people that would be in the audience for the ads; being diagnosed is not a criterion.

r. Question S5 [Consumer] of Study 1 should be eliminated. Whether a subject still has chronic pain has no bearing on the study's purpose. Also, consider eliminating Question Q12 of Study 1. This question would only apply to those consumers currently being treated for chronic pain, not those who previously had the condition.

(Response) Assessing whether participants currently experience chronic pain helps to ensure a motivated sample for which the fictitious medication would potentially be of interest. Originally, we included participants that reported suffering from chronic pain in the past, but we did not require that they are currently suffering from chronic pain (although we had an item that asked “Do you still have this chronic or long-lasting pain?”). After further consideration, we opted to revise the screener so that participants remain eligible if (a) they say “Yes” I still have chronic pain, or (b) they say “No” (or remain silent) about still having chronic pain and they are currently taking a prescription drug for chronic pain. This would also make the inclusion criteria for Study 1 consistent with the inclusion criteria for Study 2, which requires that a person currently suffers from the medical condition of interest. Consequently, Q12 of Study 1 will be relevant for all consumers completing the questionnaire.

s. Consider revising Question S5 [PCP] of Study 1 to inquire: (1) What percentage of the PCP's patients has each condition, and (2) how long the PCP has treated patients with each condition. A PCP's familiarity and experience with the treatment of the particular condition provides context and serves as a reference for detecting any potential deception in promotional materials.

(Response) We appreciate how these additional questions could provide valuable context and propose adding new items to our pretest survey (see below). We have found, in past work, that HCPs often have difficulty recalling precise information about their practice. Consequently, our approach is to assess this information more generally. However, to include some additional context, we included two additional items:

• Rate your current knowledge about prescription drugs for [weight loss/chronic pain] on a scale of 0 to 10, where 0 means knowing nothing and 10 means knowing everything you could possibly know about the topic.

• [If “chronic pain”] Approximately what proportion of your current patients do you treat for chronic pain? (None or very few have chronic pain; a small proportion have chronic pain; about one-half have chronic pain; a large proportion have chronic pain; almost all have chronic pain).

t. Question Q2 of Study 1 should have a third answer choice: “Don't remember.”

(Response) In cognitive interviews, very few people chose this response option. Moreover, in previous research, because so few people chose this response option, we often end up collapsing this response option with the response indicating that the referent was not mentioned in the website.

u. Questions Q5 and Q7 of Study 1 should be deleted. Whether a subject considers the website to be “Bad/Good” or “Boring/Interesting” has no relevance to FDA's study goals.

(Response) These items help to mask the overall intent of the other items in this series (e.g., to assess whether the website is misleading). Also, they provide useful information about personal relevance and attitude toward the website, which we can use as potential covariates.

v. The commenter recommends revising Question Q17 of Study 1: “How likely are you to ask your doctor about [Drug]?”

(Response) The intent of this item is to assess information-seeking more broadly, which can include, but is not limited to, asking one's doctor about a drug. While assessing how consumers access information from various sources (doctor, family members, etc.) is of interest, our survey does not have room to ask about each source individually. Given that there are multiple sources of information a consumer might consult for more information on a drug, we decided to address information-seeking more broadly with one question, rather than attempting to list all possible options.

w. Questions Q19 and Q21 of Study 1 should be removed. These questions require participants to guess whether the material would mislead people or “takes advantage of less experienced” consumers/providers. FDA should only ask participants about individual perception. Additionally, it is unclear what the Agency means by “takes advantage of less experienced” consumers/providers.

(Response) To avoid redundancy, we dropped Q21. We retained Q19 to ensure assessment of a critical construct. Because deception is a complicated construct to measure, we included a variety of items to capture the various dimensions of this construct. Based on a review of the literature, we recommend using a variety of relatively sensitive measures of ability to detect misleading advertisements to ensure we capture potentially meaningful variance. The inclusion of Q19 and Q21 were based on findings from the literature review that included measures that tapped into third-person perception (Ref. 17)—which is among the most widely replicated phenomena across media contents (Ref. 18), such as DTC prescription drug advertising (Ref. 19). By including an item that taps into third-person effects, we will be able to explore if consumers are more likely to think that others will be misled, even if they do not think they are susceptible to being misled by the website.

x. Question Q24 of Study 1 should be one of the first questions of the survey. A subject will likely answer this question most accurately immediately after reviewing the website and before answering other questions that could influence this answer.

(Response) To avoid bias, the most critical questions should appear as up front as possible in the surveys. Although current question ordering may bias responses to the attention item, this outcome is less consequential and we chose instead to prioritize the key dependent variables (putting those measures that rely on memory at the start of the survey). Consequently, we intend to retain the current order of questions in the survey.

y. The box for Question Q30 of Study 1 prompts the subject to respond, even if the individual did not select anything in the website as false or misleading. FDA should consider using a tiered response:

Q30a: Did you notice anything on the website that is false or misleading?

1. Yes (go to question 30b).

2. No (go to question 31).

Q30b: What information was false or misleading? [open box comment]

(Response) A programming note was missing in the original survey draft. The current survey programming reflects the approach suggested by the commenter.

z. The commenter recommends revising Question Q32 of Study 1 to: “If there was a way to report misleading prescription drug websites or ads to the Food and Drug Administration (FDA) by sending an email or calling a toll-free phone number, how likely would you report misleading material?”

(Response) We have adopted this recommendation in the revised survey.

aa. As previously stated in footnote 21, Questions Q34, Q41, and Q42 of Study 1 should be deleted.

Footnote 21 reads: For example, FDA completed a HCP study incorporating information asked at Q34, Q41, and Q42 of Study 1. It is not clear why the Agency is undertaking another study focusing on such questions. These questions should be eliminated.

(Response) Please see our response to Comment 3d.

bb. Question S1 of Study 2 should be rewritten as follows: “Have you ever been diagnosed with obesity, defined as body mass index greater than or equal to 30?” This change aligns the question with the description of the study in the PRA Notice: “Study 2 will sample consumers diagnosed with obesity. . . .”

(Response) For this study, our intent was to target people that would be in the audience for these ads, and being diagnosed is not a requirement for personal relevance. The target audience is consumers with a body mass index greater than or equal to 30.

cc. The “Debriefing” does not accurately portray the purpose of the studies. The purpose of the studies is not “to learn about how people feel about information provided in prescription drug websites aimed at consumers/providers and how people use this information to understand how well prescription drugs work.” The commenter recommends that the “Debriefing” read: “The purpose of this study is to investigate the ability of consumers/providers to identify false or misleading prescription drug promotion and how likely consumers/providers are to report false or misleading prescription drug promotion to regulatory authorities.”

(Response) We have adopted this recommendation.

(Comment 4) regulations.gov tracking number 1k1-8v3r-jacf (summarized for brevity):

a. The commenter expressed concern about the practical utility of the consumer-oriented arms of the research. Namely, if consumers are unfamiliar with the prescribing information for the product, it is unclear on which basis they can determine a claim to be deceptive.

(Response) Please see our response to Comment 3f, which addresses a similar theme and may provide useful context. The concern addressed by the commenter is framed as a limitation of the study and appears to question the relevance of examining consumers' ability to detect deception in prescription drug promotion. We believe the opposite is correct: The merit of conducting the study is reinforced by the observation that it is unclear how consumers can determine a claim to be deceptive if they lack relevant background information or knowledge about an advertised drug. While prescription drug promotions are required to present truthful and non-misleading information, some prescription drug promotion nevertheless includes false or misleading claims, images, or presentations. DTC prescription drug promotion can help provide consumers with truthful information about drugs. When it does so, it can help consumers to make well-informed decisions when determining whether to explore treatment options and when making ultimate treatment choices, and it can provide useful and actionable information about a product's efficacy and risks to consumers already on treatment, among other outcomes. Yet, because the information in prescription drug promotion is not always truthful, consumers must make judgments about whether it is true, misleading, or false. And the same background knowledge that a consumer might rely on to identify a claim as deceptive would also be used to decide that a claim is true. As the commenter points out, this background information may be incomplete or inadequate for the task, and yet some presume that consumers (and, for that matter, healthcare providers) are typically able to distinguish between true claims and those that are false or misleading. Concerns like the one voiced here and the empirical literature on the topic suggest there is reason to doubt this presumption, thus warranting the proposed study.

b. The commenter expressed concern that the varied causes of obesity will result in a heterogeneous population which could potentially confound the results of the study.

(Response) We consider diversity within this illness population to be an asset. Also, random assignment will help to control extraneous influences because it will create groups that, on average, are probabilistically similar to each other. Because randomization eliminates most other sources of systematic variation, researchers can be reasonably confident that any effect that is found is the result of the intervention and not some preexisting differences between the groups (Ref. 20). Consequently, the varied causes of obesity should not impact the results. The primary intention of the research is to empirically examine consumer and HCP ability to detect and report deceptive prescription drug promotion, but we have to choose stimuli (and by extension, an illness population) in order to empirically test our research questions. By choosing illness conditions with diverse patient populations, we can better grasp how consumers and HCPs from all walks of life react to deceptive prescription drug promotion. Also see response to comment 3j.

(Comment 5) regulations.gov tracking number 1k1-8v3v-v60p (verbatim with header and footer language, introductory language, and supporting references removed):

We strongly support FDA's proposed project as part of the Agency's broader research efforts to better understand the impact of prescription drug promotion and direct-to-consumer advertising (DTC). Research regarding deceptive advertising is becoming increasingly important as DTC continues to grow at unprecedented rates. One analysis estimated DTC spending in 2015 at $5.2 billion—a growth of over 60 percent in just 4 years. Five drugs—HUMIRA, LYRICA, ELIQUIS, CIALIS, and XELJANZ—accounted for one-quarter of this $5.2 billion. Importantly, these figures are an underestimate, as they do not account for spending on digital ads and social media.

The risks and benefits of DTC have been well noted and debated. DTC may promote patient dialogue with healthcare providers and remove the stigma associated with certain diseases. However, there are also significant concerns that DTC may be misleading, overemphasize a drug's benefits as compared to risks, and lead to inappropriate prescribing and overutilization.

Again, we applaud the FDA's efforts in this important area. The need to better understand the ability of consumers and healthcare professionals to detect and report misleading DTC is critical as the use of DTC continues to grow. Thank you for the opportunity to provide these comments.

(Response) FDA appreciates this support.

FDA estimates the burden of this collection of information as follows:

The following references are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

NOROXIN (norfloxacin) tablets, 400 mg, is the subject of NDA 019384, held by Merck & Company, Inc. (Merck), and initially approved on October 31, 1986. NOROXIN is indicated for the treatment of adults with the following infections caused by susceptible strains of certain designated microorganisms: Uncomplicated urinary tract infections (including cystitis), uncomplicated urethral and cervical gonorrhea, and prostatitis.

In a letter dated October 13, 2015, Merck notified FDA that NOROXIN (norfloxacin) tablets, 400 mg, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book. In the Federal Register of October 4, 2016 (81 FR 68427), FDA announced that it was withdrawing approval of NDA 019384, effective November 3, 2016.

Jubilant Generics Ltd. submitted a citizen petition dated April 27, 2017 (Docket No. FDA-2017-P-2659), under 21 CFR 10.30, requesting that the Agency determine whether NOROXIN (norfloxacin) tablets, 400 mg, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NOROXIN (norfloxacin) tablets, 400 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that NOROXIN (norfloxacin) tablets, 400 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NOROXIN (norfloxacin) tablets, 400 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list NOROXIN (norfloxacin) tablets, 400 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to NOROXIN (norfloxacin) tablets, 400 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised, the Agency will advise ANDA applicants to submit such labeling.

FDA is announcing the availability of a guidance for industry entitled “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” This guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. The disclosure of the product name in promotional labeling and advertisements for all human prescription drugs, including prescription biological products, and animal prescription drugs is important for the proper identification of such products to ensure their safe and effective use.

The placement, size, prominence, and frequency of the proprietary and established names for human prescription drugs, including prescription biological products, and for prescription animal drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and (h) and 202.1(b), (c), and (d)).

The recommendations in this guidance pertain to product names in traditional print promotional labeling and advertisements (e.g., journal ads, detail aids, brochures), audiovisual promotional labeling (e.g., videos shown in a health care provider's office), broadcast advertisements (e.g., television advertisements, radio advertisements), and electronic and computer-based promotions (e.g., internet, social media, emails, CD-ROMs, DVDs).

In the Federal Register of November 20, 2013 (78 FR 69691), FDA announced the availability of the revised draft guidance entitled “Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.” FDA received one comment on the revised draft guidance, which requested additional clarification on the individual recommendations in the guidance, and FDA considered this comment as the guidance was finalized. In addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised draft guidance and to provide examples illustrating prominence issues.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. The information collection requests in support of the guidance are discussed below. Specifically, the guidance discusses the requirement in FDA's regulations for prescription drug promotional labeling and advertisements to include the established name in conjunction with the proprietary name, and explains FDA recommendations that:

• Firms should include the established name at least once per page or spread where the proprietary name most prominently appears.

• The established name should be placed either directly beside or below the proprietary name without any intervening matter.

• The size of the established name should be at least half the size of the presentation of the proprietary name wherever the established name is required.

• For superimposed text that is equivalent to a headline or tagline, the established name should be presented alongside the most prominent presentation of the proprietary name in audiovisual promotional materials (promotional labeling and broadcast advertisements).

• For electronic and computer-based promotion, the established name should accompany the proprietary name at least once per Web page, and this should generally be where the proprietary name most prominently appears on the Web page.

Thus, the guidance recommends that firms disclose certain information to others to fulfill the product name placement requirements found in FDA's regulations. This “third-party disclosure” constitutes a “collection of information” under the PRA. Disclosures in advertising pursuant to 21 CFR 202.1 are covered by an existing information collection (OMB control number 0910-0686), so this information collection request covers only disclosures in labeling in accordance with 21 CFR 201.10(g) and (h).

In the Federal Register of November 20, 2013, FDA published a 60-day notice requesting public comment on the proposed collection of information and the estimated annual burden for third party disclosure. FDA received no comments in response to the four information collection topics solicited in the notice. FDA has received more up-to-date submission data since the 60-day notice published, therefore, we have adjusted our estimates of respondents and disclosures accordingly. The estimated amount of time per disclosure has not changed. We therefore estimate the burden associated with the information collection as follows:

As reflected in table 1, we provide an estimate of the annual third-party disclosure burden associated with this collection of information. The placement, size, prominence, and frequency of the proprietary and established names for human prescription drugs, including prescription biological products, and animal prescription drugs are specified in labeling and advertising regulations (21 CFR 201.10(g) and (h); 202.1(b), (c) and (d); and 610.62). Using calendar year 2015 data, FDA estimates that, for prescription human and animal drugs and biological products, approximately 407 firms disseminate approximately 104,358 advertisements and promotional pieces each year. We further estimate that the burden hours associated with the regulatory requirements would be approximately 3 hours per disclosure.

FDA is issuing this final guidance subject to OMB approval of the information collection. Before implementing the information collection provisions of the guidance, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the collections of information, including OMB control number(s) for newly approved collections.

This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information associated with 21 CFR 202.1 have been approved under OMB control number 0910-0686.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Sections 525 through 528 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360aa-360dd) give FDA statutory authority to do the following: (1) Provide recommendations on investigations required for approval of marketing applications for orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set forth conditions under which a sponsor of an approved orphan drug obtains exclusive approval, and (4) encourage sponsors to make orphan drugs available for treatment on an “open protocol” basis before the drug has been approved for general marketing. The implementing regulations for these statutory requirements have been codified under part 316 (21 CFR part 316) and specify procedures that sponsors of orphan drugs use in availing themselves of the incentives provided for orphan drugs in the FD&C Act and sets forth procedures FDA will use in administering the FD&C Act with regard to orphan drugs.

Section 316.10 specifies the content and format of a request for written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of marketing applications. Section 316.12 provides that, before providing such recommendations, FDA may require results of studies to be submitted for review. Section 316.14 contains provisions permitting FDA to refuse to provide written recommendations under certain circumstances. Within 90 days of any refusal, a sponsor may submit additional information specified by FDA. Based on past experience, FDA estimates that there will be one respondent to §§ 316.10, 316.12, and 316.14 requiring 50 hours of human resources annually.

Section 316.20 specifies the content and format of an orphan drug application which includes requirements that an applicant document that the disease is rare (affects fewer than 200,000 persons in the United States annually) or that the sponsor of the drug has no reasonable expectation of recovering costs of research and development of the drug. Section 316.21 specifies content of a request for orphan drug designation required for verification of orphan-drug status. Section 316.26 allows an applicant to amend the applications under certain circumstances. Based on past experience, FDA estimates 496 respondents to §§ 316.20, 316.21, and 316.26, requiring 83,700 hours of human resources annually.

The Common EMEA/FDA Application for Orphan Medicinal Product Designation form for orphan designation of drugs intended for rare diseases or conditions (Form FDA 3671) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from both the European Commission and FDA by reducing the burden of preparing separate applications to meet the regulatory requirements in each jurisdiction. It highlights the regulatory cooperation between the United States and the European Union mandated by the Transatlantic Economic Council. The FDA Orphan Drug Designation Request Form (Form FDA 4035) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from only FDA. The form is a simplified method for sponsors to provide only information required by 21 CFR 316.20 for FDA to make a decision. Based on past experience, FDA estimates there will be 496 respondents using the form requiring 19,840 hours of human resources annually.

Section 316.22 specifies requirement of a permanent resident agent for foreign sponsors. Based on past experience, FDA estimates 70 respondents requiring 140 hours of human resources annually. Section 316.24(a) specifies a requirement that sponsors respond to deficiency letters from FDA on designation requests within 1 year of issuance of the deficiency letter, unless within that time frame, the sponsor requests an extension of time to respond. Based on past experience, FDA estimates 20 respondents requiring 40 hours of human resources annually.

Section 316.27 specifies content of a change in ownership of orphan-drug designation. Based on past experience, FDA estimates 63 respondents requiring 315 hours of human resources annually. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. Based on number of orphan-drug designations, the number of respondents is estimated as 744 requiring 2,232 hours of human resources annually. Finally, § 316.36 describes information required of sponsor when there is insufficient quantity of approved orphan drug. Based on past experience, FDA estimates two respondents requiring 90 hours of human resources annually.

The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers.

In the Federal Register of June 19, 2017 (82 FR 27836), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

FDA has experienced increases in: (1) The number of submissions to change ownership of orphan-drug designation (§ 316.27), (2) the number of annual reports (§ 316.30), and (3) assurances of the availability of sufficient quantities of the orphan drug and the holder's consent for the approval of other marketing applications for the same drug (§ 316.36).

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports FDA regulations under § 101.8 (21 CFR 101.8) and Form FDA 3757. Under § 101.8(d) vending machine operators not subject to the requirements of section 403(q)(5)(H)(viii) (21 U.S.C. 343(q)(5)(H)(viii)) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may, through an authorized official, voluntarily register with FDA to be subject to those requirements. Those who do voluntarily register must provide FDA with contact information, the address of the location of each vending machine owned or operated by the vending machine operator that is being registered, the preferred mailing address (if different from the vending machine operator address) for purposes of receiving correspondence, and certification that the information submitted is true and accurate, that the person or firm submitting the information is authorized to do so, and that each registered vending machine will be subject to the requirements of § 101.8(c)(2). We have developed Form FDA 3757 entitled, “DHHS/FDA Menu and Vending Machine Labeling Voluntary Registration,” to assist respondents in this regard. To keep the establishment's registration active, the authorized official of the vending machine operator must register every other year within 60 days prior to the expiration of the vending machine operator's current registration with FDA. Registration will automatically expire if not renewed.

It should be noted that an article of food sold from a vending machine whose operator has voluntarily registered with FDA under the regulations is not required to provide calorie declarations for articles of food sold from a vending machine that permits the prospective purchaser to examine the Nutrition Facts label before purchasing the article as provided in § 101.8(b)(1), or otherwise provides visible nutrition information at the point of purchase as provided in § 101.8(b)(2).

FDA estimates the burden of the collection of information as follows:

As reflected in table 1, we retain the currently approved reporting burden estimate for the information collection. At this time, we lack comprehensive data on the number of vending machine operators with fewer than 20 machines that might voluntarily register to comply with the regulations and, as indicated in our final rule of December 1, 2014 (79 FR 71259) establishing the information collection, no vending machine operators have voluntarily registered with FDA. Therefore, while we expect relatively few submissions, we have provided a conservative estimate of the burden respondents may encounter.

We estimate there are approximately 757 vending machine operators with fewer than 20 machines; this number is based on the mean estimate of the low and high counts of firms with less than $50,000 in annual revenue. We estimate that 5 percent of vending machine operators with fewer than 20 machines may voluntarily register to become subject to the final requirements, or 38 operators. We estimate a burden of approximately 2 hours per initial registration, which yields a total burden of 76 hours (38 total operators × 2 hours per response). Annualizing this number over 3 years yields a rounded 13 respondents per year (5 percent × 757 operators/3 years). With an annualized estimate of 13 vending machine operators and one registration per vending machine operator at 2 hours per registration, we estimate the initial hourly burden for these operators is 26 hours.

We expect that renewal registrations after the first year will require substantially less time because operators are expected to be able to affirm or update the existing information in an online account in a way similar to other FDA firm registration systems. Therefore, we estimate that re-registration will take 0.5 hours for each registrant. This indicates that biennial registration would impose a burden of 19 hours (38 operators × 0.5 hours) every 2 years, or 9.5 hours every year (19 operators every year × 0.5 hours).

We have omitted providing a burden estimate associated with generating, providing, or maintaining records associated with calorie analysis and recording because the regulations do not require vending machine operators to maintain such records. However, we have considered the “time, effort, or financial resources” expended by covered vending machine operators to declare calories for covered vending machine food and have included the burden in table 2 as part of the third-party disclosure burden. We are particularly interested in hearing from respondents to the information collection regarding calorie declaration signage.

As reflected in table 2, we have retained the currently approved third-party burden estimate for the information collection.

Under the regulations, we calculate three types of third party disclosure burden. The first burden estimate reflects the time and effort we believe necessary for vending machine operators to determine the calorie content of covered vending machine food for the required calorie declarations as described in § 101.8(c)(2)(i). We refer to this as a “calorie analysis.” A calorie analysis entails the burden of determining calorie content for covered vending machine food. Most foods sold from vending machines provide the nutrition labeling required by section 403(q) of the FD&C Act and 21 CFR 101.9, including calorie content information, which means that calorie content for many covered vending machine foods is already available on the Nutrition Facts labels for such foods. In that case, vending machine operators will not need to determine the calorie content of such foods because they can simply declare the calorie information they find on the Nutrition Facts label. Nevertheless, some operators may need to determine calorie information for those vending machine foods that may not bear Nutrition Facts labels or otherwise provide visible nutrition information at the point of purchase in accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and § 101.8(b). An operator may obtain the necessary calorie information from nutrient databases, cookbooks, or laboratory analyses. Calorie analysis will most likely only be needed for vended food items such as refrigerated, frozen, can/bowl, or other shelf-stable main meal items, hot cup beverages, and cold cup beverages.

We estimate the mean number of vending machine operators that need calorie analysis to be 847. Annualizing this estimate over 3 years yields 282 operators. We also estimate the range of products available in a typical machine for each of the three most commonly sold product categories that are likely to require a calorie analysis, or 3 percent of food items, 5 percent of hot beverages, and 1 percent of cold cup beverages. We estimate that food machines typically offer between 10 and 25 different items, and both hot beverage and cold cup beverage machines typically offer between 5 and 10 items. From this, we estimate each vending machine operator will require a calorie analysis for 11 items, on average. These estimates are based upon conversations with vending machine operators and our survey of various vending machine models that vend these types of food and beverage, as discussed in our final rule. Based on available data, we estimate the time needed to determine the calorie content of each covered vending machine food to be approximately 1 hour. Our estimate for the burden hours required for new calorie analysis is then 9,317 hours (847 operators × 11 products needing analysis × 1 hour per analysis). Annualizing this value over 3 years yields 3,102 hours (847 operators/3 years × 11 products needing analysis × 4 hours per analysis). (847 operators/3 years = 282 operators per year.) This is reflected in table 2, row 1.

The second burden estimate reflects burden associated with calorie declaration signage as described in § 101.8(c)(2)(ii). Covered vending machine operators with 20 or more vending machines and vending machine operators that voluntarily register to become subject to the Federal requirements must disclose calorie information by providing calorie declaration signs in, on, or adjacent to their vending machines to a third party who will most often be the prospective purchaser or consumer.

We estimate there is an average of 9,838 (9,800 covered non-bulk + 38 voluntary) vending machine operators subject to the regulations (9,838/3 = 3,279 annualized). Our estimate for the average number of non-bulk vending machines that will require declaration signage is based upon data relied upon in our final rule (see references 1, 6 to 8 under Docket No. FDA-2011-F-0171). We estimate there is an average of 5.61 million non-bulk vending machines. Digital signage is an emerging technology, and according to available sources, approximately 0.1 percent of all vending machines in operation currently have electronic video displays capable of providing calorie information, or approximately 4,014 to 5,670 vending machines. Subtracting the number of vending machines with the electronic video from the total machine count yields an average of 5.61 million vending machines that will need signage. We expect the number of vending machines that will require signage to decline over time as manufacturers continue to add the required calorie information to the principal display panel of the package as part of “front of package labeling,” and because we anticipate greater use of electronic video displays on vending machines. In addition, to the extent that covered vending machines sell foods that permit prospective purchasers to examine the Nutrition Facts label before purchase or otherwise provide visible nutrition information at the point of purchase in accordance with section 403(q)(5)(H)(viii)(I)(aa) of the FD&C Act and § 101.8(b), this analysis may overestimate the burden estimate for calorie declaration signs.

Vending machine operators can create one sign that contains all of the information for the products offered in the vending machine, and do not have to create individual signs for each item. The number of templates a given firm would need to design to produce signs that comply with the regulations may vary based upon the number of different types of products the firm purveys. In our estimate, we have considered the time it takes for template design, sign creation, sign installation, updates, replacement, and bulk machine signage. Cumulatively we estimate that those 3,279 (annualized) vending machine operators subject to the regulations will expend a total 1,494,403 hours to fulfill the requirements under § 101.8(c)(2)(ii) regarding signage for calorie declarations. This is reflected in table 2 row 2. We note that while we previously provided burden estimates for individual disclosure activities found under § 101.8(c)(2)(ii) in our final rule of December 1, 2014 (79 FR 71259 at 71286), we have consolidated them here into one entry. Because this is the first extension request for this information collection and we have limited available data, we are specifically interested in respondents' experience with the third-party burden associated with the requirements under § 101.8(c)(2)(ii).

Finally, we have provided a burden estimate associated with § 101.8(e)(1) requiring a vending machine operator subject to section 403(q)(5)(H)(viii) of the FD&C Act or a vending machine operator that voluntarily registers to provide contact information. We assume that venders that do not already have a sign or label with their contact information will add their contact information into the initial sign design. We estimate the time it takes to include contact information is 1.5 minutes (0.025 hours) for each sign. We estimate the total initial burden for including contact information on the predesigned templates to be 30,744 hours (9,838 operators × 125 sign formats × 0.025 hours per sign). Annualized over 3 years, this burden becomes 10,248 hours (9,838 operators/3 years × 125 signs × 0.025 hours per sign). (Some States have licensing requirements for vending machine operators, and some of these licensing requirements already require the vending machine operator's license or contact information to be displayed on the vending machine.) If the contact information displayed on a vending machine due to State or local requirements includes some but not all of the contact information required under § 101.8(e)(1), the vending machine operator is required to display the remaining contact information required under § 101.8(e)(1) in a manner specified under § 101.8(e)(1). We do not have an estimate of the number of machines already in compliance; to the extent that some operators are already in compliance, we overestimate the associated burden for third-party disclosure.) This is reflected in table 2, row 3.

During negotiations on the Medical Device User Fee Amendments of 2012 (MDUFA III), Title II, Food and Drug Administration Safety and Innovation Act (Pub. L. 112-114), FDA agreed to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among these commitments included:

• Annually posting a list of priority medical device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (the “A-list”), and

• Annually posting a list of device guidance documents that the Agency intends to publish, as the Agency's guidance-development resources permit each fiscal year (the “B-list”).

The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA Reauthorization Act of 2017 (Pub. L. 115-52) maintained these commitments.

FDA welcomes comments on any or all of the guidance documents on the lists as explained in 21 CFR 10.115(f)(5). FDA has established Docket No. FDA-2012-N-1021 where comments on the FY 2018 lists, draft language for guidance documents on those topics, suggestions for new or different guidances, and relative priority of guidance documents may be submitted and shared with the public (see ADDRESSES). FDA believes this docket is a valuable tool for receiving information from interested persons and will update these lists after considering public comments, where appropriate. FDA anticipates that feedback from interested persons will allow CDRH to better prioritize and more efficiently draft guidances to meet the needs of the Agency and our stakeholders.

In addition to posting the lists of prioritized device guidance documents, FDA has committed to updating its website in a timely manner to reflect the Agency's review of previously published guidance documents, including the deletion of guidance documents that no longer represent the Agency's interpretation of or policy on a regulatory issue.

Fulfillment of these commitments will be reflected through the issuance of updated guidance on existing topics, removal of guidances that no longer reflect FDA's current thinking on a particular topic, and annual updates to the A-list and B-list announced in this notice.

CDRH has identified as a priority, and has devoted resources to, finalization of draft guidance documents. To assure the timely completion or re-issuance of draft guidances, in FY 2015 CDRH committed to performance goals for current and future draft guidance documents. For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, re-open the comment period, or issue new draft guidance on the topic for 80 percent of the documents within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years. As part of MDUFA IV commitments, FDA reaffirmed this commitment, as resources permit. In addition, in FY 2017, CDRH withdrew 4 of 8 draft guidances issued prior to October 1, 2011, and has been continuing to work towards taking an action on the remaining draft guidances. Looking forward, in FY 2018, CDRH will strive to finalize, withdraw, or re-open the comment period for 50 percent of existing draft guidances issued prior to October 1, 2012.

CDRH has received feedback that stakeholders desire earlier involvement in the guidance process and has taken steps to create a mechanism to address this request. In FY 2016, in anticipation of guidance documents expected to be developed, CDRH sought stakeholder input regarding electromagnetic compatibility of electrically powered medical devices and regarding utilizing animal studies to evaluate the safety of organ preservation devices and solutions. FDA appreciated the feedback received and considered it in the development of these guidances. Demonstrating commitment to incorporating stakeholder input, CDRH issued a draft guidance in FY17 on utilizing animal studies to evaluate the safety of organ preservation devices, and is progressing toward issuance of draft policies reflecting early stakeholder input as appropriate.

FDA also welcomes any additional feedback for improving the guidance program and the quality of CDRH guidance documents.

CDRH has issued over 600 final guidance documents to provide stakeholders with the Agency's thinking on numerous topics. Each guidance reflected the Agency's current position at the time that it was issued. However, the guidance program has issued these guidances over a period of 30 years, raising the question of how current previously issued final guidances remain. CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders. At the website where CDRH has posted the “A-list” and “B-list” for FY 2018, CDRH has also posted a list of final guidance documents that issued in 2008, 1998, 1988, and 1978.1 CDRH is interested in external feedback on whether any of these final guidances should be revised or withdrawn. In addition, for guidances that are recommended for revision, information explaining the need for revision, such as the impact and risk to public health associated with not revising the guidance, would also be helpful as the Center considers potential action with respect to these guidances. CDRH intends to provide these lists of previously issued final guidances annually through FY 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. For instance, in the annual notice for FY 2019, CDRH expects to provide a list of the final guidance documents that issued in 2009, 1999, 1989, and 1979; the annual notice for FY 2020 is expected to provide a list of the final guidance documents that issued in 2010, 2000, 1990, and 1980, and so on. CDRH will consider the comments received from this retrospective review when determining priorities for updating guidance documents and will revise these as resources permit.

In FY 2017, CDRH received comments regarding guidances issued in 2007, 1997, and 1987, and has withdrawn 32 guidance documents in response to comments received and because these guidance documents were determined to no longer represent the Agency's current thinking. The revision of several guidance documents is also being considered as resources permit.

Consistent with the Good Guidance Practices regulation at 21 CFR 10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or withdraw an already existing guidance document. We request that the suggestion clearly explain why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. While we are requesting feedback on the list of previously issued final guidances located in the annual agenda website, feedback on any guidance is appreciated and will be considered.

This notice announces the website location of the document that provides the A and B lists of guidance documents, which CDRH is intending to publish during FY 2018. To access these two lists, visit FDA's website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.htm. We note that the topics on this and past guidance priority lists may be removed or modified based on current priorities, as well as comments received regarding these lists. Furthermore, FDA and CDRH priorities are subject to change at any time (e.g., newly identified safety issues). The Agency is not required to publish every guidance on either list if the resources needed would be to the detriment of meeting quantitative review timelines and statutory obligations. In addition, the Agency is not precluded from issuing guidance documents that are not on either list.

Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2017 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2017, CDRH issued 9 of 27 guidances on the FY 2017 list (6 from the A-list, 3 from the B-list). At this time, CDRH has decided not to pursue several guidances that were on the FY 2017 A or B list, due to factors including feedback from industry.

Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the Advisory Council, in consultation with the Secretaries of Defense and Agriculture. Activities of the Advisory Council are governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.

The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Advisory Council shall function solely for advisory purposes.

In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance.

The public meeting will be dedicated to two main activities. The Advisory Council will deliberate and vote on a letter drafted by the Immediate Action Subcommittee. The remainder of the day will be focused on the topic of antibiotic stewardship in food and companion animals. The meeting agenda will be posted on the Advisory Council website at http://www.hhs.gov/ash/carb/ when it has been finalized. All agenda items are tentative and subject to change.

Public attendance at the meeting is limited to the available space. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Advisory Council at the address/telephone number listed above at least one week prior to the meeting. For those unable to attend in person, a live webcast will be available. More information on registration and accessing the webcast can be found at http://www.hhs.gov/ash/carb/.

Members of the public will have the opportunity to provide comments prior to the Advisory Council meeting by emailing [email protected]. Public comments should be sent in by midnight January 15, 2018, and should be limited to no more than one page. All public comments received prior to January 15, 2018, will be provided to Advisory Council members; comments are limited to two minutes per speaker.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The ICR documentation will be made available at http://www.reginfo.gov upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Consistent with the requirements of Executive Order (EO) 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.

OMB Control Number 1652-0028, Flight Crew Self-Defense Training—Registration and Evaluation. TSA is seeking a revision of the ICR, currently approved under OMB control number 1652-0028, to continue compliance with a statutory mandate. Under 49 U.S.C. 44918(b), TSA is required to develop and provide a voluntary advanced self-defense training program for flight and cabin crew members of air carriers providing scheduled passenger air transportation.

TSA must collect specific information in order to provide the program to eligible participants as well as assess training quality. This information includes limited biographical information from flight and cabin crew members to confirm their eligibility to participate in this training. TSA uses the information to confirm the eligibility of the participant by contacting the participant's employer.

TSA currently collects the following information at the time of registration online: Name of the crew member, airline affiliation, position, crew member airline identification (ID) number, crew member contact information (home mailing address, last four digits of the crew member's social security number (SSN), home telephone number and/or email address), and the city and state of the TSA Office of Law Enforcement/Federal Air Marshals Service (OLE/FAMS) field office where the course will be taken. Upon attending class, crew members are asked to show ID to verify their identity against registration records and to sign the class attendance roster. TSA also asks trainees to complete a voluntary TSA training evaluation form. Trainees are not required to identify themselves on the evaluation form.

TSA is revising this information collection to no longer include the collection of the last four digits of the SSN from crew members. TSA is also revising this information collection to include an electronic Injury Waiver Form. Each crew member will be asked to complete an Injury Waiver Form during the registration process, or before the training is conducted. The Injury Waiver Form requests the employee's airline, airline ID number, signature, and date, and is intended to limit any liability to TSA or its facilities should a crew member become injured during the training. Further, TSA is revising the information collection to update the attendance roster to add a “training complete” column. Finally, TSA is revising the information collection to replace the evaluation form with an electronic feedback tab. At the completion of the course, participants may assess the quality of the training off-site, on their own time, by clicking on the electronic feedback link, located on the registration site, to provide their anonymous and voluntary comments. This revision is necessary so that TSA may continue to provide the program to eligible participants as well as assess training quality.

The estimated number of annual respondents is 3,400 and estimated annual burden is 595 hours. TSA plans to graduate at least 1,700 crew members during each year of the program, an increase of 700 from the 2015 ICR submission. TSA estimates, the online registration requires five (5) minutes and the injury waiver and class roster sign-in process requires one (1) minute per crew member. This amounts to 311.67 hours [(3,400 crew members × 5 minutes) + (1,700 crew members × 1 minute)]. Although utilizing the course Feedback tab is strictly voluntary, TSA estimates ten (10) minutes per crew member for those who complete the evaluation. Assuming everyone participates, this amounts to a total of 283.33 hours (1,700 crew members × 10 minutes). TSA estimates the total annual hours for this information collection to be 595 hours (311.67 + 283.33).

This Notice sets forth a new performance measurement system for evaluating the efficacy of FSS programs, requests comment on that performance measurement system, and asks additional questions regarding these proposed changes.

In pursuit of advancing HUD's ability to evaluate the effectiveness of the FSS program, per statutory mandate (Section 23(i)(2) of the Housing Act of 1937), HUD has developed a new FSS performance measurement system to provide HUD, Congress, and public housing agencies (PHAs) with information on the performance of individual FSS programs. The information will help PHAs determine the extent to which PHAs are administering effective and impactful FSS programs that help participants to successfully graduate from the program and make progress toward economic security. The information will also help HUD understand the extent to which individual FSS program performance, and the performance of all FSS programs receiving HUD FSS coordinator funding as a group, improves or declines over time.

HUD plans to use the performance measures to identify high performing and troubled FSS programs. In the future, HUD will likely consider the FSS performance score of an FSS program in determining FSS funding awards. HUD may also use the rating system to identify PHAs that could benefit from technical assistance to improve their programs. At this time, HUD does not envision using this performance measurement system for tribes/TDHEs, who do not report into Public and Indian Housing Information Center (PIC), or for PHAs with a Moving to Work (MTW) designation, as they report differently into PIC, using Form HUD-50058-MTW. However, HUD is presently exploring a change to the reporting processes for MTW agencies in order to include them in the FSS performance scoring process.

HUD developed the approach described in this Notice based in part on feedback received on an earlier performance measurement approach proposed in the FY 2014 FSS Notice of Funding Availability (NOFA). In the FY 2014 NOFA, HUD proposed evaluating FSS programs based on the share of FSS participants that experience an increase in earned income (also known as “earnings growth”) over a specified time period. Among other feedback, commentators expressed concern that this approach did not adequately account for differences in local economic conditions and differences in the approach of local FSS programs. While some FSS programs encourage participants to increase their earnings immediately, others encourage FSS participants to build skills and credentials first and then seek higher paying jobs. The new FSS performance measurement system addresses these issues, as well as many others, allowing for a more nuanced evaluation of the performance of local FSS programs.

Under the planned performance measurement system, at least once per year, HUD will analyze data collected through the PIC to calculate FSS performance scores for each FSS program for which sufficient data are available to calculate the score. A PHA's FSS performance score will be calculated based on three measures, weighted as follows:

HUD has selected these measures because they are important indicators of program performance and are verifiable using the data HUD collects through the PIC data system. No outside or additional reporting will be required, ensuring the system does not increase the reporting burden of PHAs. No new Paperwork Reduction Act (PRA) Information Collection will be required for the scoring, as proposed.

As described below, the Earnings Performance Measure represents the difference between the earnings growth of FSS participants and the earnings growth of other similar households within the PHA within a specified time frame. This approach helps to control for variations in local economic conditions. Earnings growth is one of the primary outcomes desired from FSS; the FSS performance score therefore assigns the Earnings Performance Measure a high weight. HUD has assigned the next highest weight to the Graduation Rate indicator—which represents the rate of FSS participants who successfully “graduate” from the program—to encourage PHAs to work closely with individual FSS participants to increase graduation rates. (To graduate from FSS, a participant must be employed, be independent of welfare assistance for at least one year, and achieve the other goals set forth in the participant's contract of participation.) Finally, the FSS performance score looks at Participation Rate, which reflects the extent to which a PHA exceeds the minimum number of households that HUD requires the PHA to serve as a condition of receiving an FSS grant. PHAs with higher Participation Rates are serving more households than required, which is a desired output, provided the PHAs are serving those households effectively. Because the Earnings Performance Measure is weighted more heavily than the Participation Rate, however, PHAs should be careful not to execute more Contracts of Participation than they can serve effectively, because doing so would likely reduce their scores on the Earnings Performance Measure.

Together, the Earnings Performance Measure, Graduation Rate, and Participation Rate provide a balanced measurement of the performance of an individual FSS program. The three measures are calculated as follows:

The Earnings Performance Measure gauges the extent to which the earnings 1 of FSS participants increase over time after joining the FSS program. In developing the methodology for this measure, HUD has been sensitive to the fact that some FSS programs encourage FSS participants to immediately increase their earnings while others encourage FSS participants to first build human capital through education and training in order to qualify for higher paying jobs. The methodology is also sensitive to the fact that the earnings of low-income workers are often volatile, and that the economic conditions in which different FSS programs are operating vary from community to community.

To accommodate these different factors and control for variations among FSS programs, HUD calculates the Earnings Performance Measure for each FSS program using the process outlined below. HUD applies this process to the population of FSS participants who enrolled in the FSS program 3.5 to 7.5 years prior to the end of the most recent quarter of data available through PIC to calculate the latest FSS performance scores.

Controlling for Variations in the Composition of Local FSS Programs: While households with elderly heads or heads who are a person with disabilities may participate in FSS, such households are not included in the calculation of a PHA's earnings performance measure. This ensures that PHAs that serve larger shares of such households are not disadvantaged in the performance measurement process as compared to PHAs that serve smaller shares of such households.

Controlling for FSS Program Model and Earnings Fluctuations: To calculate an Earnings Performance Measure for a PHA, HUD first measures the growth in annual household earnings of each household enrolled in FSS at the PHA in two ways and selects the higher of the two measures for each household:

1. Earnings Growth Since Enrollment: The difference between (i) annual earnings upon enrollment in FSS and (ii) the most recent earnings estimate available in PIC for that household from an annual reexamination.

2. Average Annual Earnings While in FSS: The difference between (i) earnings upon enrollment in FSS and (ii) the household's average annual earnings during the time period between enrollment in FSS and the most recent annual reexamination of income available in PIC.

Controlling for FSS Program Model and Earnings Fluctuations: HUD selects the higher of the two measures for each household in order to accommodate different approaches to implementing FSS while also correcting for variations in year-to-year earnings, which can be volatile for low-income households. Some PHAs encourage FSS participants to focus immediately on increasing their earnings, while others encourage FSS participants to focus on obtaining education and building skills first and then seek a higher paying job once they have stronger credentials. Other agencies use both approaches, tailoring the approach to each individual. Measure 1, Earnings Growth Since Enrollment, accommodates programs that encourage participants to focus first on education and training, while both measures work acceptably for programs that encourage individuals to increase their earnings immediately. Measure 2, Average Annual Earnings While in FSS, focuses on the difference between starting and average annual earnings, which ensures that an FSS participant who has made good progress in increasing earnings while in FSS, but who nevertheless has experienced a temporary setback of job loss as of the most recent annual reexamination, nevertheless has his or her progress recognized. For each household, the Earnings Performance Measure focuses on the higher of the two measures, maximizing HUD's ability to recognize households' progress toward increased earnings while participating in FSS.

Controlling for Local Economic Conditions: Because economic conditions vary from one community to the next, HUD has built in a mechanism to control for these differences. HUD adjusts for local economic conditions by comparing the average earnings growth of FSS participants at a PHA to the average earnings growth for nonparticipants with similar characteristics at the same PHA. The difference in performance between the two groups represents the Earnings Performance Measure for that PHA. Since the earnings of non-FSS participants would be expected to grow faster at PHAs located in stronger job markets than in PHAs located in weaker job markets, this comparison helps to account for differences in local economic conditions, which facilitates a meaningful comparison of earnings growth across FSS programs. Specifically, to calculate an Earnings Performance Measure for each PHA, HUD:

• Selects three comparison households for each FSS household based on the extent to which the comparison households are similar to the FSS household on the following characteristics: Earnings as of the time of the FSS household's entry into FSS, age of head of household, length of time in the voucher or public housing program, number of adults in the household and number of children under age 5.

• Calculates the earnings growth for all of the comparison households using the same approach used to calculate the earnings growth for FSS households, with the FSS household's enrollment date being applied to its comparison households for purposes of calculating the comparison households' initial earnings.

• Calculates the difference between the average earnings growth for all FSS participants and the average earnings growth for all comparison households at each PHA. The difference between the two represents the PHA's earnings performance measure.

HUD applies this measure to all FSS participants with a head of household who is neither elderly nor a person with disabilities who joined FSS between 3.5 and 7.5 years prior to the end of the quarter of the PIC extract used to calculate the score. For example, if the most recent PIC data extract ended in March 31, 2017, HUD's calculation of earnings performance measures would focus on FSS participants who joined the FSS program between October 1, 2009 and September 30, 2013. This methodology aggregates information for four years of FSS entrants in order to generate a large enough sample to analyze. The methodology does not examine data for participants that have entered the FSS program more recently than 3.5 years ago to allow sufficient time to have passed for FSS participants to have benefitted from the program. At the same time, the methodology does not focus only on an older sample of FSS participants to ensure that the results reflect recent FSS program performance to the maximum extent practicable.

Technical note: In measuring earnings growth, the methodology focuses solely on earnings determined through annual reexaminations, disregarding the results of any interim reexaminations. The reason for doing this is that not all PHAs require interim reexaminations of income when earnings rise in between annual reexaminations. To ensure an apples-to-apples comparison of earnings growth across PHAs, HUD focuses only on annual reexaminations. An annual progress report is required for every FSS participant regardless of the spacing of rental re-examinations, so PHAs involved in rent reform demonstrations would be included in this scoring.

This measure examines the share of FSS participants at each PHA who have “graduated” from the FSS program. It is calculated based on the graduation rate of FSS participants who entered each PHA's FSS program 5 to 8 years before the end of the most recent quarter of available PIC data. The methodology focuses on these households to allow sufficient time for most of the FSS participants who will graduate to have done so. HUD considered focusing on an older cohort to capture 100 percent of the FSS participants who will graduate, but HUD determined that it was more advantageous for the period analyzed to include more recent performance by the PHA.

Controlling for Turnover Rates: Turnover rates at PHAs can vary significantly for reasons unrelated to FSS. To avoid penalizing programs with higher turnover, HUD excludes non-graduating FSS participants who exited the Housing Choice Voucher (HCV) or Public Housing programs before the end of the analysis period from both the numerator and the denominator in calculating the Graduation Rate.

The Participation Rate is the ratio of the number of FSS participants being served to the minimum number expected to be served under the standards used for awarding funding under the FSS NOFA. Agencies that exactly meet the standard will have a ratio of 1.0. Agencies that serve more than the required number will have a ratio above 1.0. Agencies that serve fewer than the required number will have a ratio below 1.0.

To calculate the Participation Rate, HUD first calculates the minimum number of FSS participants that HUD expects each PHA to serve for each of the most recent three (3) fiscal years for which both funding award and number served data are available. HUD calculates this number based on the guidelines in the NOFA and the number of coordinators funded in each agency during each year. HUD then sums the number of FSS participants actually served in each of the three years based on PIC data. Finally, HUD divides the total number of FSS participants served in each PHA by the total minimum number expected for the PHA's HUD-funded coordinator positions to determine the participation rate. If funding is only awarded to the PHA in one or two of the three years, the measure only uses data for the years for which funding was awarded. Note that this metric, while similar, is different from the “number of participants served,” which has been used in NOFA competitions and assesses only the most recent period of performance.

Controlling for Annual Variation and PIC Reporting: HUD also separately calculates the Participation Rate for the most recent year and then grades a PHA's Participation Rate based on the higher of: (a) The PHA's three-year average and (b) the most recent year. Looking at the higher of the these two values allows HUD to use the most recent available data for PHAs that have made progress in increasing the number served while avoiding penalizing PHAs for the results of an atypical year. It also ensures that PHAs that have improved the quality of their PIC reporting on FSS participation can be judged based on the FSS participant counts derived from recent PIC reports, rather than from reports submitted in earlier years. Given the new guidance that HUD issued on PIC reporting for FSS on May 16, 2016 (PIH Notice 2016-08), HUD expects the quality of FSS reporting to PIC to be improved going forward and reminds PHAs of the importance of ensuring accurate and timely submissions of FSS Addendums to PIC.

As calculated using the procedures described above, the participation rate is higher if the PHA has served more participants relative to its funding level. The ratio required in the NOFA is 25 for one full-time coordinator and 50 for each additional full-time coordinator. For example, a PHA with 1 funded full-time coordinator is expected to serve at least 25 participants during the year, while a PHA with 3 funded full-time coordinators is expected to serve at least 125 participants. If the PHA with 1 coordinator serves 40 FSS participants (much more than the minimum required) and the PHA with 3 coordinators serves 130 participants (only slightly more than the minimum expected), the PHA with the smaller number of coordinators and participants will have a higher participation rate (40/25 = 1.60 versus 130/125 = 1.04).

PHAs that receive funding jointly with other PHAs are evaluated together in calculating the participation rate. HUD sums the number of FSS participants served by each of the jointly-funded agencies and the minimum number of participants the agencies are jointly expected to serve and provides the same participation score for each of the PHAs.

After making the calculations described above, HUD will develop an FSS Performance Score for each PHA using a two-step process.

In Step One, HUD will assign a score of 0 to 10 to each PHA's FSS program for each of the three measures. Scores will be assigned using the procedures described below. The ranges for awarding points between two values include those values as well as all intermediary values.

For each of the three measures, HUD has selected criteria for evaluating PHA performance. For each measure, the highest performers are assigned a score of 10, the next-highest performers are assigned a score of 7.5, and low performers are assigned a score of 0. HUD will award a score of 5 to PHAs whose performance does not satisfy the criteria for highest, next-highest, or low performance for that measure.

• 10 points: Earnings performance measure of $6,400 or higher.

• 7.5 points: Earnings performance measure between $4,750 and $6,399.

• 0 points: Earnings performance measure below $1,500 and a p-value of .10 on a statistical test measuring the likelihood that a PHA's earnings performance measure is significantly lower than the median measure of $3,418 (see below for an explanation of this statistical test).

• 5 points: All PHAs that do not qualify for a 10, 7.5, or a 0.

As described above, a PHA's earnings performance measure represents the difference between: (a) The average earnings growth for FSS participants and (b) the average earnings growth for comparison households at the same PHA. A PHA's earnings performance measure is not simply a measure of the extent to which FSS participants increased their earnings. Instead, a PHA's earnings performance measure reflects the relative growth of FSS participants relative to a matched set of non-participants at that PHA. HUD assigns a higher score to FSS programs that achieve a higher earnings performance score.

In addition to focusing on the size of the earnings performance measure, the scoring for this measure applies a one-tailed test of statistical significance, designed to protect FSS programs from being scored “low performer” due to random variation and low sample size. For example, without this protection, an individual FSS program may include several anomalous participants or control households that skew research results. The statistical test measures the likelihood that a PHA's earnings performance measure is significantly lower than the median measure. The lower the p-value, the less likely it is that a PHA received a below-median earnings performance measure due to random variation. To receive 0 points, a PHA must not only have an earnings performance measure below $1,500 but also a p-value on this test of less than .10, which means there is at least a 90 percent probability that the earnings performance measure is truly below the median value of $3,418.

While a similar statistical test could theoretically be applied to help identify high performing programs, such a test would make it harder for small FSS programs to qualify. To avoid disadvantaging smaller FSS programs, p-values are not considered in determining whether to award 10 or 7.5 points.

• 10 points: Graduation rate of 38 percent or higher.

• 7.5 points: Graduation rate between 27 percent and 37.99 percent.

• 0 points: Graduation rate of 8 percent or lower.

• 5 points: All PHAs that do not qualify for a 10, 7.5, or a 0.

Under this approach, a higher graduation rate results in a higher score.

• 10 points: Participation rate of 2.1 or higher.

• 7.5 points: Participation rate between 1.7 and 2.09.

• 0 points: Participation rate of 0.95 or lower.

• 5 points: All PHAs that do not qualify for a 10, 7.5, or a 0.

Under this approach, a higher participation rate results in a higher score.

After computing individual scores for each of the three measures, HUD aggregates each PHA's scores using the weights noted above to develop a final FSS Performance Score from 0 to 10. Based on this score, HUD assigns the following ranking to the PHA's performance:

• Excellent: FSS Performance score of 7.25 or higher.

• Standard: FSS Performance score between 4.0 and 7.24.

• Low: FSS Performance score between 3.00 and 3.99.

• Troubled: FSS Performance score of less than 3.00.

The thresholds for converting the three performance measures into scores in step one are fixed and will now apply to all future years until HUD revises the methodology. These thresholds were selected by applying the FSS Performance Score methodology to PIC data from the quarter ending December 31, 2016. The thresholds were selected as follows:

• The threshold for awarding a score of 10 points (an earnings performance measure of $6,400) represents approximately the 80th percentile of the distribution of results of the earnings performance measure for PHAs whose measures have a p value >.10 on a statistical test measuring the likelihood that the earnings performance measure is different from $0. HUD calculated the distribution using agencies that receive a p value below .10 on this test to reduce the likelihood that the results would be affected by random variation.

• The threshold for awarding a score of 7.5 points ($4,750) represents approximately the 60th percentile of the distribution of results of the earnings performance measure for PHAs whose measures have a p value <.10 on the statistical test described above.

• The threshold for awarding a score of 0 points ($1,500) represents approximately the 20th percentile of the distribution of results of the earnings performance measure for all PHAs.

• The threshold for awarding a score of 10 points represents approximately the 80th percentile of the distribution of graduation rates.

• The threshold for awarding a score of 7.5 points represents approximately the 60th percentile of the distribution of graduation rates.

• The threshold for awarding a score of 0 points represents approximately the 20th percentile of the distribution of graduation rates.

• The threshold for awarding a score of 10 points represents approximately the 80th percentile of the distribution of participation rates.

• The threshold for awarding a score of 7.5 points represents approximately the 60th percentile of the distribution of participation rates.

• The threshold for awarding a score of 0 points is 0.95, which falls below the minimum standard established by HUD. A PHA serving the minimum number of FSS participants required to obtain FSS funding would normally have a participation rate of 1.0. However, this methodology uses a score of 0.95 to give PHAs the benefit of the doubt and account for any temporary vacancies in the FSS program.

• The threshold for awarding a ranking of Excellent represents approximately the 80th percentile of the distribution of FSS Performance Scores.

• The range for awarding a ranking of Low represents approximately the 10th through the 20th percentiles in the distribution of FSS Performance Scores.

• Programs falling below approximately the 10th percentile in the distribution of FSS Performance Scores are classified as Troubled.

• All other FSS programs are classified as “Standard” performers. The range for awarding a ranking of Standard represents approximately the 20th through the 80th percentiles of the distribution of FSS Performance Scores.

As noted above, all thresholds are now fixed and will not be recalculated each year. This will facilitate tracking individual PHA progress as well as that of all FSS programs over time. Further, this framework does not limit how many programs can receive any particular ranking. The thresholds are absolute, not relative.

The following is additional information about how HUD calculates FSS performance scores:

1. For households entering FSS more than one time during the analysis period, the methodology focuses only on the FSS Contract of Participation that began 5 to 8 years before the end of the most recent quarter of available PIC data to calculate the FSS performance score. This facilitates appropriate evaluation of each program's graduation rate, which focuses on the same group of households. If a participant entered more than once during that period, the methodology focuses on the older entry.

2. FSS performance scores are calculated for any PHA that has sufficient data in PIC to calculate at least one of the three measures used to calculate the score. If there are insufficient data to calculate one or two of the measures, that PHA will receive a middle (standard) score of “5” for the missing measure(s) before calculating the FSS performance score.

3. A PHA for which none of the three scores are available will not receive a score.

4. Because the earnings performance measure and the graduation rate are calculated using data that spans a range of years, it will take time for a PHA to improve its FSS Performance Score through improvements in earnings and graduation outcomes. However, improvements in these areas will eventually become apparent in a PHA's FSS Performance Score. It is important for PHAs with low scores to begin implementing improvements as quickly as possible. PHAs with participation rates below 0.95 can quickly improve their FSS Performance Scores by increasing participation rates to meet HUD's minimum requirements.

HUD is interested in evaluating the performance of all FSS programs administered by PHAs, including programs that do not receive funding from HUD. However, there are several concerns with applying the methodology described above to the evaluation of the performance of non-funded agencies. First, the participation rate cannot be calculated using the methodology described in this notice because there are no set expectations for program size. Second, such programs tend to be smaller than NOFA-funded programs, which means their results are more subject to random variation due to the participation of individuals with idiosyncratic features. Third, these program participants tend to receive less personal attention from FSS coordinators due to the lack of dedicated funding from HUD for FSS.

HUD will continue studying options for measuring the performance of such agencies to determine if an approach can be developed for evaluating the quality of their FSS programs. To inform HUD's analysis of this issue, HUD requests comments on the following questions:

1. Should HUD evaluate FSS programs that do not receive funding from HUD?

2. Should the performance of an unfunded FSS program be considered by HUD in determining whether to award funding? If not, what factors should be used in determining whether to award funding to a currently unfunded agency?

3. Should the FSS performance score of an unfunded PHA be compared solely with that of other unfunded PHAs or also against the performance of funded agencies?

4. How should the procedures for evaluating the performance of funded FSS programs be adapted for purposes of measuring the performance of FSS programs that do not receive funding?

5. Should HUD calculate a participation rate for unfunded FSS programs in evaluating their performance and if so, how should it be calculated?

6. In addition to, or instead of a participation rate, should HUD limit the evaluation of non-funded agencies to FSS programs over a certain size, such as 15 or 25 participants? Focusing only on FSS programs of a certain minimum size should help to improve the reliability of the evaluation results while also focusing the evaluation (and any corresponding preference for funding) on PHAs that demonstrate a threshold level of commitment to the FSS program.

In addition to the questions noted above, HUD requests feedback on the following questions:

1. Has HUD assigned the appropriate weight to each of the three measures? The proposed system uses the following weights: Earnings performance measure (50 percent); Graduation rate (30 percent); and Participation rate (20 percent).

2. In evaluating earnings growth, HUD focuses on the average of the earnings growth of individual households at a PHA, rather than median growth. HUD takes this approach to recognize the potential life-changing impacts of helping individuals move from unemployment to high-paying jobs. Such impacts are captured in looking at average earnings growth, but might be missed in looking only at the median growth. It is appropriate in this context to use averages, or should HUD switch to medians instead?

3. Has HUD adequately accounted for variations in local economic conditions? If not, what further adjustments should be made? The earnings performance measure accounts for local economic conditions by comparing the earnings growth for FSS participants at a PHA to the earnings growth for non-FSS participants at the same PHA with similar characteristics. The assumption underlying this approach is that earnings growth for non-FSS participants will be higher in areas with stronger job markets than in areas with weaker job markets. To attain the same earnings performance measure, a PHA in an area with a strong job market would thus need to demonstrate a higher level of earnings growth among FSS participants than would a PHA in an area with a weaker job market. After calculating the difference between earnings growth for FSS and non-FSS participants at a PHA, the proposed system makes no further adjustments. Should HUD further adjust its system to account for variations in local economic conditions, and if so, how should HUD make this adjustment? For example, HUD could divide the earnings performance measure by the average starting earnings for a PHA's FSS participants and then compare the resulting percentages across PHAs. Further, HUD could adjust the earnings performance measures by an index that accounts for local economic conditions.

4. HUD currently allows a PHA to count FSS participants living in multifamily FSS programs toward the minimum number of participants required to be served in order to qualify for FSS funding. The PIC data system, however, does not capture information on multifamily FSS participants. HUD requests suggestions on how best to capture information on multifamily FSS participants being served by a PHA's FSS coordinator to determine a PHA's participation rate.

5. HUD currently permits, and funds, FSS programs in Tribes and Tribally Designated Housing Entities (TDHEs). However, Tribes and TDHEs do not report into the PIC data system. HUD requests suggestions on how to best capture information on tribal FSS participants to determine a score.

6. HUD currently permits, and funds, FSS programs at MTW agencies. However, MTW agencies are only required to report select FSS data fields into the PIC system. HUD requests suggestions on how to best capture information on MTW FSS participants to determine a score.

7. How should HUD evaluate FSS programs offered by HUD-assisted multifamily properties with Section 8 contracts? These programs are very new and currently submit quarterly spreadsheets rather than an FSS addendum integrated into a HUD data reporting system.

This notice does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

Since October 2011, all Public Housing Agencies (PHAs) operating the Housing Choice Voucher (HCV) program in the Dallas, TX HUD Metro FMR Area have been using Small Area Fair Market Rents (Small Area FMRs). The use of Small Area FMRs was intended to give HCV families access to areas of high opportunity and lower poverty by providing a subsidy that is adequate to cover rents in those areas, thereby reducing the number of voucher families that reside in areas of high poverty concentration. The PHAs in Dallas began using Small Area FMRs as the result of a legal settlement.

HUD announced the commencement of the Small Area FMR demonstration in November 2012. Five PHAs participated voluntarily in this demonstration, which sought to assess the effect on families of using FMRs published at the U.S. Postal Service ZIP code level (i.e., Small Area FMRs) in lieu of FMRs published at the metropolitan area level.1

In 2015, HUD awarded a cooperative agreement to Abt Associates to evaluate the use of Small Area FMRs by the five PHAs that voluntarily participated in the demonstration, as well as two PHAs operating the voucher program in the Dallas, TX HUD Metro FMR Area. Abt was charged with examining whether and to what extent providing higher subsidies in ZIP code areas where rents are higher, and lower subsidies in ZIP code areas where rents are lower, helps HCV families to better access areas of opportunity. HUD also requested that the evaluation examine how the transition from metropolitan-wide to Small Area FMRs affected families and landlords, and the impact of Small Area FMRs on HCV subsidy and administrative costs.

On November 16, 2016, HUD published its “Establishing a More Effective Fair Market Rent System; Using Small Area Fair Market Rents in the Housing Choice Voucher Program Instead of the Current 50th Percentile FMR” final rule (81 FR 80567). This final rule required the use of Small Area FMRs in certain metropolitan areas instead of the 50th percentile rent previously used. On the same day, HUD published a notice listing areas in which the use of Small Area FMRs is mandatory beginning on October 1, 2017 (81 FR 80678).

On April 26, 2017, HUD received Abt's Small Area Fair Market Rent Demonstration Evaluation Interim Report.2 The Interim Report examines changes in outcomes from 2010 to 2015 and documents several findings that HUD finds concerning. In addition, it indicates that further research is needed to address several critical questions with respect to the potential harm to HCV families (both participants and applicants) and PHAs in areas transitioning to Small Area FMRs.

On August 10, 2017, pursuant to the authority provided in regulation, HUD suspended the designation for the mandatory use of Small Area FMRs for 23 of the 24 metropolitan areas that would become subject to the requirement on October 1, 2017 (Suspension).3 The Suspension was made pursuant to 24 CFR 888.113(c)(4), which provides that HUD may suspend the Small Area FMR designation for a metropolitan area when HUD by notice makes a documented determination that such action is warranted. Specifically, § 888.113(c)(4) provides:

Based on the findings in Abt's Small Area Fair Market Rent Demonstration Evaluation Interim Report, summarized above, HUD has concerns that the mandatory use of Small Area FMRs, without sufficient preparation and mitigation of potential unintended consequences, could put some PHAs at risk of causing an adverse rental housing market condition. Accordingly, after careful consideration, HUD issued the Suspension of the Small Area FMR designation for 23 of the 24 metropolitan areas that had previously been designated for mandatory Small Area FMR use. The Suspension was for two Federal fiscal years (FYs), becoming effective at the beginning of FY 2020 (October 1, 2019) instead of FY 2018. To provide notice to affected PHAs, HUD sent letters to more than 200 PHAs in the 23 metropolitan areas noted in the Suspension. Additionally, HUD posted an article regarding the Suspension on its website.4

The delayed implementation of mandatory Small Area FMR adoption will provide HUD with reasonable time to analyze the final findings of the demonstration and determine what measures are necessary to mitigate negative effects, if possible. For example, the delay may allow HUD to develop guidance and technical assistance that is informed by the lessons learned from the demonstration.

Notwithstanding the exercise of this authority, the Small Area FMR Rule permits any PHA that voluntarily seeks to adopt SAFMRs to do so. The program regulations at 24 CFR 888.113(c)(3) provide that a PHA administering an HCV program in a metropolitan area not subject to the mandatory application of Small Area FMRs may opt to use Small Area FMRs by seeking approval from HUD's Office of Public and Indian Housing (PIH) through written request to PIH. In light of the findings of Abt's Small Area Fair Market Rent Demonstration Evaluation Interim Report referenced above, should HUD receive a request under this provision, HUD will consider in its approval determination a PHA's ability to provide reasonable assurance that adoption of Small Area FMRs will not result in an adverse housing market condition.

With this notice, HUD seeks public comment on the Suspension. While HUD is not required to post the Suspension for public comment, this notice solicits comment for a period of 30 days. At the expiration of the 30-day period, HUD will review the comments and consider if any further changes to the Suspension are necessary. Interested parties can find the Suspension in the Supporting Documents section of the docket associated with this notice, at www.regulations.gov, and on HUD's website at https://www.huduser.gov/portal/datasets/fmr/smallarea/index.html.

I. Background

Under the leadership of President Donald J. Trump, the Administration is committed to reforming government services and expanding opportunities for more Americans to become self-sufficient. The EnVision Center demonstration focuses on empowering people to leave HUD-assisted housing through self-sufficiency to become responsible homeowners and renters in the private market. By doing so, HUD will be able to make those resources available to others and help more Americans.

The EnVision Centers demonstration is premised on the notion that financial support alone is insufficient to solve the problem of poverty. Intentional and collective efforts across a diverse set of organizations are needed to implement a holistic approach to foster long-lasting self-sufficiency. EnVision Centers will provide communities with a centralized hub for support in the following four pillars: (1) Economic Empowerment, (2) Educational Advancement, (3) Health and Wellness, and (4) Character and Leadership. The Economic Empowerment pillar is designed to improve the economic sustainability of individuals residing in HUD-assisted housing by empowering them with opportunities to improve their economic outlook. The Education pillar seeks to bring educational opportunities directly to HUD-assisted housing and includes partnering with public and private organizations that approach education in non-traditional ways on non-traditional platforms. The Health and Wellness pillar is designed to improve access to health outcomes by individuals and families living in HUD-assisted housing. The Character and Leadership pillar is designed to enable all individuals and families residing in HUD-assisted housing, especially young people, to reach their full potential as productive, caring, responsible citizens by encouraging participation in volunteer and mentoring opportunities.

Through results-driven partnerships with federal agencies, state and local governments, non-profits, faith-based organizations, corporations, public housing authorities (PHAs), tribal designated housing entities (TDHEs) and housing finance agencies, EnVision Centers will leverage public and private resources for the benefit of individuals and families living in HUD-assisted housing. HUD anticipates that positive outcomes for individuals and households will generate additional positive impacts at the community-wide level. EnVision Centers will also break down the silos of government, and co-locate government services that lead to self-sufficiency.

A January 2011 report from the Government Accountability Office (GAO) that focused on Temporary Assistance for Needy Families, Employment Services and Workforce Investment Act Adult employment programs funded by the U.S. Departments of Labor, Education, and Health and Human Services, found that while it would be a challenge, efficiencies in offering government services could be achieved by co-locating services and consolidating administrative structures.1 EnVision Centers will bring together in one place, federal, state and local government services, community based organization services, non-profit mission based organization services and faith based organization services that lead economic self-sufficiency and ultimately, greater economic mobility.

Every resident living in public or assisted housing should have access to the opportunities economic mobility can provide. This demonstration is designed to encourage and create a platform for communities to collaborate with community supportive service providers, other businesses, foundations, nonprofit organizations, educational leaders, job training and workforce development organizations, and others to advance economic mobility in their communities and to test the effectiveness of a collaborative set of actions that address all barriers to economic sufficiency. The demonstration will build upon existing partnerships and continue collaborative work to improve the lives of residents housed with HUD assistance by providing a forum by which cross-sector organizations can come together to design and implement local interventions to advance economic mobility.

HUD's goal is to identify a sample of diverse communities from different geographies and of varying sizes that have the capacity to effectively and expediently implement the demonstration to serve HUD-assisted families. HUD seeks the interest of communities where local leadership has already taken steps to support the goals of the demonstration, as measured by both the community's participation in other complementary Federal initiatives supporting economic mobility, as well as local plans and strategies for addressing the four pillars.

Participation in the demonstration by these communities will build upon existing efforts already underway to expand economic mobility, thereby building the comprehensive and coordinated set of resources that will result in the long-term, sustainable employment that places individuals and families on track to become self-sufficient.

As part of this demonstration, HUD will provide technical assistance, evaluation and monitoring, access to online resources such as the EnVision Center mobile application, access to stakeholder offerings made available to participating communities and a network of support from HUD's departments to ensure that all relevant HUD knowledge resources are made available to participating communities. HUD believes that communities participating in the EnVision Center demonstration will benefit from the collaboration made possible under this demonstration with: Local, state and federal government services, community based organization services, non-profit mission based organization services and faith based organization services that will lead to the development of economic self-sufficiency and ultimately, greater economic mobility for those most in need within these communities.

HUD will use the following criteria to assess communities that have expressed an interest in participating in the demonstration:

(1) The mayor or equivalent executive elected official of the community, and the PHA's or TDHE's executive leader, must formally announce a commitment to enhance economic mobility and in so doing identify skills gaps that exist in their community among distinct neighborhoods and demographics, the resolution of which will support long-term, sustainable employment that places individuals and families in HUD-assisted housing on track to become self-sufficient.

(2) Communities should commit to developing and implementing a plan to promote and expand economic mobility. The development of this plan will serve as a vehicle for bringing various stakeholders together and providing them with a tangible path for achieving the goals of the demonstration. As an example, the plan could specify and formalize the participation of community stakeholders, describe gaps in current service delivery models, identify a physical location(s) which can act as a shared services site to house the EnVision Center, and/or outline specific benchmarks and goals for the EnVision center. Communities' participation plans will be expected to describe the goals of the community's participation in the demonstration and provide, to the extent possible, objective goals regarding the number of partnerships established with state and local government, non-profits, faith based organizations, and private and philanthropic organizations.

(3) To ensure the presence of local support and leverage HUD infrastructure for implementation of this demonstration, communities should be currently participating in one or more Federal place-based initiatives, such as: The Promise Zones program; PHAs participating in the Moving to Work Demonstration, the Byrne Criminal Justice Innovation program; the Strong Cities, Strong Communities program; the JobsPlus program; the Family Self-Sufficiency program and the Resident Opportunities and Self-Sufficiency (ROSS) program; the ConnectHome program; existing Neighborhood Networks sites; existing Family Investment sites; the ROSS for Education Program; the Energy and Economic Development program (SEED); or the Building Neighborhood Capacity program.

(4) Communities should be broadly committed to realizing the Office of American Innovation 2 vision, especially, developing “workforce of the future” programs, modernizing government services and information technology, improving services to veterans, creating transformational infrastructure projects, implementing regulatory and process reforms, creating manufacturing jobs, and addressing the drug and opioid epidemic.

(5) As a condition of participation, selected entities are required to cooperate in full with HUD staff and/or any contractors affiliated with HUD, in the implementation and evaluation of this program.

(6) After selection, HUD will finalize a set of measurement tools to evaluate the program's impact and effectiveness. Selected respondents will be required to keep records to document how the Demonstration is being implemented, cooperate with the evaluation, and cooperate in [any] the formal independent evaluation of the Demonstration.

These criteria are meant to create optimal conditions to accelerate the adoption and use of the EnVision Center model. However, the criteria may be applied with reasonable flexibility to ensure that a diverse set of communities are considered for participation in this demonstration. Approximately 10 communities are anticipated to initially participate in the demonstration. As the demonstration proceeds, HUD will assess expressions of interest from communities and the availability of HUD staffing resources to support additional participation. Additionally, as the demonstration proceeds, HUD will assess the effectiveness of the participation criteria on an ongoing basis. As a result of these assessments, HUD may expand the number of participating communities, revise the participation criteria, or both to reflect HUD's experience in implementing the demonstration.

In advance of commencement of the demonstration, HUD will sponsor or co-sponsor one or more meetings of communities, cross-sector entities, and other stakeholders to facilitate the sharing of information and identify communities interested in participation in the demonstration. HUD will reach out to communities that have formally declared a commitment to advance economic mobility and otherwise meet the criteria described above to participate in those meetings. HUD also invites interested communities to reach out to HUD to note their interest and request attendance at a stakeholder meeting. HUD therefore encourages interested communities to take the necessary steps to meet the criteria as quickly as possible in order to be best positioned to realize the benefits of these discussions.

HUD may partner with an existing entity that has a national organizational presence sufficient to provide a strong coordinating function across communities, government, and the private and nonprofit sectors. The entity should have significant expertise in community services, economic mobility and the four pillars. It should possess strong existing relationships with industry, foundations, universities, and nonprofit and non-governmental agencies. Finally, it should have community project experience, including educational and outreach activities in underserved populations.

Communities interested in participating in this demonstration must submit a written commitment by the mayor or equivalent executive elected official of the community (municipality, county, tribal nation or state), and the PHA or TDHE executive leader, to advancing economic mobility and empowering HUD-assisted households to become self-sufficient. This commitment, must also respond to the items outlined in Section II.1. above, as well as identification of the Federal place-based initiatives in which it is involved, as requested by Section II.1.(3.) above. In addition, HUD will require submission of an EnVision Center plan that outlines specific benchmarks and goals for the EnVision Center as outlined in Section II of this notice. Communities seeking to participate in this demonstration must submit this information to [email protected].

The information collection requirements contained for the EnVision Center Demonstration will be submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB control number.

In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning this collection of information to:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Interested persons are invited to submit comments regarding the information collection requirements in this notice. Comments must refer to the proposal by name and docket number (FR-6069) and must be sent to:

HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503, Fax: (202) 395-6947, and, Office of Legislation and Regulations, Office of General Counsel, Department of Housing and Urban Development, Room 10282, 451 7th Street SW, Washington, DC 20410.

Interested persons may submit comments regarding the information collection requirements electronically through the Federal eRulemaking Portal at http://www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the http://www.regulations.gov website can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

HUD will work with entities across the government and the broader research community to rigorously measure outcomes associated with the efforts resulting from this demonstration to advance economic mobility. With this research, HUD intends to improve and build on the demonstration, with the goal of extending the demonstration on a nationwide basis. The participating communities and cross-sector entities are expected to participate in any HUD-sponsored evaluation and other efforts designed to identify and share best practices from the demonstration with other HUD-assisted communities. In addition, participating communities and entities will be required to collaboratively develop and subsequently measure and report outputs and outcomes.

In accordance with section 470 of the Housing and Urban-Rural Recovery Act of 1983 (42 U.S.C. 3542), HUD is seeking comment on the demonstration. Section 470 provides that HUD may not begin a demonstration program not expressly authorized by statute until a description of the demonstration program is published in the Federal Register and a 60-day period expires following the date of publication, during which time HUD solicits public comment and considers the comments submitted. The public comment period provided allows HUD the opportunity to consider those comments during the 60-day period, and be in a position to commence implementation of the demonstration following the conclusion of the 60-day period.

While HUD welcomes comments on the entirety of the demonstration, it asks that commenters consider the following specific questions:

(1) In administering and evaluating the demonstration, how should HUD define “economic mobility”?

(2) How can HUD tailor the Economic Empowerment Pillar of the Demonstration to identify and focus on families and individuals residing in HUD-assisted housing that are able to work, and not those who are elderly or include persons with disabilities;

(3) How can HUD and identified partners (state and local entities, private sector, philanthropic, non-profit and other entities) best maximize existing programs and efforts across agencies in a coordinated and holistic approach?

(4) What impediments exist for achieving the four pillars, including institutional, organizational, legal or statutory, and behavioral impediments? Is it necessary to the success of the demonstration that communities link all four pillars, and if not, would it be sufficient for a community to identify in its participation plan the barriers to including a specific pillar? Are there additional pillars that contribute to self-sufficiency and economic mobility that should be made part of the demonstration?

(5) What incentives and programs have worked in the past to achieve the four pillars?

(6) What elements and level of detail should HUD require in a community's participation plan?

(7) How should HUD define and measure economic mobility over time and space? How should HUD measure quality of life for residents that remain in assisted housing?

(8) What data sources or data linkage is needed to develop outcome metrics such as, return on investment, involvement of local institutions of higher learning, employment and economic opportunities for Section 3 residents and businesses, and a public process for reviewing outcomes and lessons learned?

We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft Supplement to the Grizzly Bear Recovery Plan: Habitat-Based Recovery Criteria for the Northern Continental Divide Ecosystem (NCDE). The draft supplement, which will be appended to the Grizzly Bear Recovery Plan upon finalization, proposes to establish habitat-based recovery criteria for the NCDE grizzly bear population. In addition, the Service hereby gives notice that a public workshop will be held to review the habitat-based recovery criteria for the grizzly bear in the NCDE. The workshop will allow scientists and the public to submit oral and written comments. The Service solicits review and comment from the public on this draft supplement. In the lower 48 States, grizzly bears (Ursus arctos horribilis) are federally listed as threatened under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.; ESA), outside of the Greater Yellowstone Ecosystem.

Restoring an endangered or threatened animal or plant to the point where it is again a secure, self-sustaining member of its ecosystem is a primary goal of the Service's endangered species program. To help guide the recovery effort, the Service prepares recovery plans for the federally listed species native to the United States where a plan will promote the conservation of the species. Recovery plans describe site-specific actions necessary for the conservation of the species; establish objective, measurable criteria which, when met, may result in a determination that the species no longer needs the protection of the ESA; and provide estimates of the time and cost for implementing the needed recovery measures (16 U.S.C. 1533(f)(1)(B)).

We approved the first Grizzly Bear Recovery Plan for grizzly bears in the lower 48 States on January 29, 1982 (U.S. Fish and Wildlife Service 1982). In 1993, we approved a revision to the Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1993), which included additional tasks and new information that increased the focus and effectiveness of recovery efforts. The 1993 Recovery Plan identifies distinct Recovery Zones and unique recovery criteria for six different grizzly bear populations, including the NCDE, with the intent that these individual populations would be delisted as they each achieve recovery (U.S. Fish and Wildlife Service 1993, pp. ii, 33-34). Supplements to the Recovery Plan were approved in 1997, 1998, 2007, and 2017 (U.S. Fish and Wildlife Service 1997, 1998, 2007a, 2007b, 2017).

Under the ESA, recovery plans must include objective, measurable recovery criteria, including habitat-based recovery standards (16 U.S.C. 1533(f)(1)(B)(ii)). A Grizzly Bear Recovery Plan Task Force also recommended further consideration of this issue, stating that we should work to “establish a threshold of minimal habitat values to be maintained within each Cumulative Effects Analysis Unit in order to ensure that sufficient habitat is available to support a viable population” (U.S. Fish and Wildlife Service 1993, p. 76). The draft habitat-based recovery criteria were developed in part by taking into account the oral and written comments received at the habitat-based recovery criteria workshop, which was held on July 7, 2016, in Missoula, Montana (81 FR 29295, May 11, 2016), and during the public comment period that followed the workshop. The Service has decided to hold a second habitat-based recovery criteria workshop.

The ESA requires the Service to provide public notice and opportunity for public review and comment on recovery plans prior to final approval (16 U.S.C. 1533(f)(4)). The Service will consider all information received during a public comment period when preparing each new or revised recovery plan for approval. The Service and other Federal agencies also will take these comments into consideration in the course of implementing approved recovery plans. It is our policy to request peer review of recovery plans. Comments received at the upcoming workshop announced in this Federal Register notice and during the public comment period will be used to inform the final habitat-based recovery criteria, which will be appended to the 1993 Grizzly Bear Recovery Plan for the NCDE and incorporated into the NCDE Grizzly Bear Conservation Strategy. The Recovery Plan sets out guidance for the Service, States, and other partners on methods to minimize threats to grizzly bears and criteria that may be used to measure if recovery has been achieved while the Conservation Strategy guides post-delisting management.

As described above, the Service will hold a public workshop seeking input and ideas on objective, measurable habitat-based recovery criteria available at https://www.fws.gov/mountain-prairie/es/grizzlyBear.php. We seek ideas and information about characteristics of habitat necessary to support a recovered population of grizzly bears and habitat parameters that can be measured and directly related to grizzly bear population health. The Service also wants to obtain information and comments on methods for monitoring the habitat-based recovery criteria. The workshop will be held in Missoula, Montana, on the date specified in DATES at the location specified in ADDRESSES. Participants are invited to present information in oral and written form. All comments presented orally should also be submitted in writing to facilitate review of these comments. Those wishing to present information or comments orally at the workshop are asked to contact the Grizzly Bear Recovery Office (see ADDRESSES) so that oral presentations can be scheduled in advance.

All information and comments received at the workshop or during the public comment period will be considered in finalizing the habitat-based recovery criteria for the NCDE.

The Service solicits public comments on a draft Supplement to the Grizzly Bear Recovery Plan. Specifically, this supplement proposes to append habitat-based recovery criteria for the Northern Continental Divide Ecosystem to the Grizzly Bear Recovery Plan. All comments received by the date specified in DATES will be considered prior to approval of the final Supplement to the Grizzly Bear Recovery Plan. Written comments and materials regarding the plan should be submitted as specified in ADDRESSES.

If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov. Comments and materials we receive will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the Grizzly Bear Recovery Office address specified in ADDRESSES.

A list of the references cited in this notice may be found at http://www.regulations.gov in Docket No. FWS-R6-ES-2017-0057.

The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f).

In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provides the requested data in the desired format.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on August 16, 2017 (82 FR 38933). No comments were received.

We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of OSMRE; (2) is the estimate of burden accurate; (3) how might OSMRE enhance the quality, utility, and clarity of the information to be collected; and (4) how might OSMRE minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Title: 30 CFR part 870—Abandoned Mine Reclamation Fund—Fee Collection and Coal Production Reporting.

OMB Control Number: 1029-0063.

Summary: The information is used to maintain a record of coal produced for sale, transfer, or use nationwide each calendar quarter, the method of coal removal and the type of coal, and the basis for coal tonnage reporting in compliance with 30 CFR 870 and section 401 of Public Law 95-87. Individual reclamation fee payment liability is based on this information. Without the collection of this information, OSMRE could not implement its regulatory responsibilities and collect the fee.

Bureau Form Number: OSM-1.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Coal mine permittees.

Total Estimated Number of Annual Responses: 11,672.

Estimated Completion Time per Response: 2-6 minutes, depending on whether respondent efiles or paper files.

Total Estimated Number of Annual Burden Hours: 389 hours.

Respondent's Obligation: Mandatory.

Frequency of Collection: Quarterly.

Total Estimated Annual Nonhour Burden Cost: $361,500.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

The DOL, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation process to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This process helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.

The DOL-Only ICR was developed based on the requirements in WIOA Sec. 116. The Department amended the information collection by adding the performance-related reporting requirements for SCSEP to the Participant Individual Record Layout (PIRL) (ETA-9172), and (Program) Performance Report (ETA-9173).

The Department requires grantees to certify and submit the ETA (Program) Performance Report to ETA on a quarterly basis. ETA will aggregate the information the grantees submit through the PIRL to populate the ETA (Program) Performance Report and grantees will confirm their accuracy.

The OAA-2016 amended the SCSEP core indicators of performance and requires the amended measures to be implemented by regulation by December 31, 2017. SCSEP will retain its current ICR (under OMB Control Number 1205-0040) for data elements not contained in the revised DOL-Only Performance Accountability, Information and Reporting System. This ICR incorporates the SCSEP Interim Final Rule citations, as required by 5 CFR 1320.11(h). Those citations are sections 20 CFR parts: 641.700, 641.710, 641.720, 641.730, 641.740, and 641.750.

The OAA amended the measures of performance for SCSEP in large part to align SCSEP performance measures with the three employment outcome indicators mandated for WIOA core programs under WIOA sec. 116(b)(2)(A)(i)(I)-(III). In addition to these three WIOA employment outcome indicators of performance, SCSEP has three measures related to participation in the program: Service level, hours of community service, and service to the most-in-need.

The Department proposes to amend the information collection by adding the regulatory citations from the SCSEP Interim Final Rule to comply with the PRA. The Department plans to review and analyze any comments received in response to this Federal Register Notice in order to finalize the substantive information collection requirements to the extent legally possible.

The Department is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submissions of responses).

Agency: DOL-ETA.

Title of Collection: DOL-Only Performance Accountability, Information, and Reporting System.

Type of Review: Revision.

OMB Control Number: 1205-0521.

Affected Public: State, Local, and Tribal Governments; Individuals or Households; and Private Sector—businesses or other for-profits and not-for-profit institutions.

Obligation to Respond: Required to Obtain or Retain Benefits.

Estimated Total Annual Respondents: 17,532,542.

Estimated Total Annual Responses: 35,064,970.

Estimated Total Annual Burden Hours: 8,938,029.

The Bureau of Labor Statistics (BLS) awards funds to State agencies in the 50 States, the District of Columbia, Puerto Rico, Guam, and the Virgin Islands, hereinafter referred to as the “States”) in order to jointly conduct BLS/State Labor Market Information and Occupational Safety and Health Statistics cooperative statistical programs, which themselves have been approved by OMB separately, as follows:

To ensure the timely flow of information and to be able to evaluate and improve the BLS/State cooperative programs' management and operations, it is necessary to conduct ongoing communications between the BLS and its State partners. Whether information requests deal with program deliverables, program enhancements, operations, or administrative issues, questions and dialogue are crucial to the successful implementation of these programs.

Office of Management and Budget clearance is being sought for the General Inquiries to State Agency Contacts. Information collected under this clearance is used to support the administrative and programmatic needs of jointly conducted BLS/State Labor Market Information and Occupational Safety and Health Statistics cooperative statistical programs.

The Bureau of Labor Statistics is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

• Enhance the quality, utility, and clarity of the information to be collected.

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

Type of Review: Extension of a currently approved collection.

Agency: Bureau of Labor Statistics.

Title: General Inquiries to State Agency Contacts.

OMB Number: 1220-0168.

Affected Public: State, Local, or Tribal Government.

Total Respondents: 54.

Frequency: As needed.

Total Responses: 23,890.

Average Time per Response: 40 minutes.

Estimated Total Burden Hours: 15,927.

Total Burden Cost (capital/startup): $0.

Total Burden Cost (operating/maintenance): $0.

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.