Federal Register Vol. 82, No.238,

The General Conference Committee (the Committee) of the National Poultry Improvement Plan (NPIP) is the Secretary's Advisory Committee on poultry health. The Committee serves as a forum for the study of problems relating to poultry health and, as necessary, makes specific recommendations to the Secretary concerning ways the U.S. Department of Agriculture may assist the industry in addressing these problems. The Committee assists the Department in planning, organizing, and conducting the Biennial Conference of the NPIP. The Committee recommends whether new proposals should be considered by the delegates to the Biennial Conference and serves as a direct liaison between the NPIP and the United States Animal Health Association.

The Committee consists of an elected member-at-large who is an NPIP participant and an elected member (and alternate) from each of the six U.S. regions represented on the Committee. Terms will expire for three current regional members of the Committee, as well as the member-at-large, in June 2018. We are soliciting nominations from interested organizations and individuals to replace the member-at-large and members from the North Atlantic (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont), East North Central (Illinois, Indiana, Michigan, Ohio, and Wisconsin), and Western (Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming) regions.

Member selection is determined by a majority vote of the NPIP delegates from the respective regions. The member-at-large will be elected by a majority vote of all official delegates. There must be at least two nominees for each position. Persons interested in serving on the Committee or nominating another individual to serve must complete Form AD-755, which is available on the internet at https://www.ocio.usda.gov/document/ad-755 or may be obtained by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

To ensure the recommendations of the Committee have taken into account the needs of the diverse groups served by the Department, membership should include, to the extent practicable, individuals with demonstrated ability to represent underrepresented groups (minorities, women, and persons with disabilities). At least one nominee from each of the three regions, as well as for the member-at-large, must be from an underrepresented group. The voting will be by secret ballot of official delegates, and the results will be recorded.

Title: Commercial Transportation of Equines for Slaughter.

OMB Control Number: 0579-0332.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: Sections 901-905 of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 1901) authorize the Secretary of Agriculture to issue guidelines for regulating the commercial transportation of equines for slaughter by persons regularly engaged in that activity within the United States. Specifically, the Secretary is authorized to regulate the food, water, and rest provided to these equines while the equines are in transit and to review related issues appropriate to ensuring that these animals are treated humanely. Based on that authority, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) established regulations in 9 CFR part 88, “Commercial Transportation of Equines for Slaughter.”

The regulations in part 88 provide minimum standards that cover, among other things, the food, water, and rest provided to such equines prior to transportation. The regulations also prohibit the commercial transportation for slaughter of equines considered to be unfit for travel, the use of electric prods on such animals in commercial transportation for slaughter, and the use of double-deck trailers for commercial transportation of equines for slaughter.

APHIS' regulations also require the application of backtags and the completion of owner/shipper certificates of fitness to travel to a slaughter facility that include identification of the animals, details of the transportation, and signatures attesting to compliance with the provision of food, rest, and water, and to the animal's fitness to travel. In addition, any owner/shipper transporting equines to slaughtering facilities outside the United States must present the owner-shipper certificates to USDA representatives at the U.S. border.

Implementing these regulations entails the use of information collection activities, such as providing business information, completing owner/shipper certificates of fitness to travel to a slaughter facility, certificates of veterinary inspection, maintaining records of the owner/shipper certificate and continuation sheet, and applying backtags, as needed.

The information collection requirements above are currently approved by the Office of Management and Budget (OMB) for the commercial transportation of equines for slaughter under OMB control numbers 0579-0332 and 0579-0160. After OMB approves this combined information collection package (0579-0332), APHIS will retire OMB control number 0579-0160.

We are asking OMB to approve our use of these information collection activities, as described, for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the 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 our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.465 hours per response.

Respondents: Owners and shippers of slaughter horses, owners or operators of slaughtering facilities, and drivers of the transport vehicles.

Estimated annual number of respondents: 302.

Estimated annual number of responses per respondent: 61.

Estimated annual number of responses: 18,500.

Estimated total annual burden on respondents: 8,608 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The Committee has a maximum of 45 members. The Department of Commerce is seeking nominations for immediate consideration to fill positions on the Committee for the 2017-2019 charter term, and will continue to accept nominations under this notice on an on-going basis for two-years for consideration to fill vacancies that may arise during the charter term. Member appointment terms run for two-years concurrently with the Committee charter. Members will be selected based upon their ability to advise the Secretary of Commerce on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and to provide advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. The Committee provides detailed policy and technical advice, information, and recommendations to the Secretary regarding:

(1) National, state, or local factors in trade programs and policies that affect the efficient domestic and international operation and competitiveness of U.S. global supply chains from point of origin to destination;

(2) elements of national policies affecting the movement of goods, infrastructure, investment, and regulatory factors that affect supply chain competitiveness and sustainability; and

(3) information and data systems to generate metrics that can be used to quantify and improve supply chain performance.

Members shall be selected in a manner that ensures that the Committee remains balanced in terms of product and service lines and reflects the diversity of the supply chain sector, including in terms of geographic location and company size.

Members of the Committee shall represent companies, organizations, and stakeholders involved in the U.S. supply chain, with at least one individual representing each of the following: Supply chain firms or their associations; users of supply chains (e.g., retailers, distributors, manufacturers or other sectors); freight transportation providers; ports; and academia. Based on the balance of viewpoints currently represented on the Committee, representatives from the rail, trucking, airport, energy, logistics and freight forwarding, infrastructure financing, and big data analysis sectors are encouraged to apply.

Other than the experts from academia, all members shall serve in a representative capacity, expressing the views and interests of a U.S. company or U.S. organization, as well as its particular sector. Members serving in such a representative capacity are not Special Government Employees. The members from academia serve as experts and therefore are Special Government Employees (SGEs) and shall be subject to the ethical standards applicable to SGEs. Members who serve as SGEs must certify that they are not Federally-registered lobbyists.

Each member of the Committee must be a U.S. citizen and not registered as a foreign agent under the Foreign Agents Registration Act. All appointments are made without regard to political affiliation. Self-nominations will be accepted.

Members of the Committee will not be compensated for their services or reimbursed for their travel expenses. The Committee shall meet approximately quarterly, or as determined by the DFO.

Members shall serve at the pleasure of the Secretary.

All nominations for membership on the Committee should provide the following information:

(1) Name, title, and relevant contact information (including phone, fax, and email address) of the individual requesting consideration; and

(2) An affirmative statement that the applicant is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938.

In addition to the above requirements for all nominations, nominations for representatives of companies, organizations, and stakeholders involved in the U.S. supply chain, including supply chain firms or their associations; users of supply chains (e.g., retailers, distributors, manufacturers, or other sectors); freight transportation providers; and ports, should also provide the following information:

(1) A sponsor letter on the letterhead of the sponsoring U.S. company or U.S. organization to be represented, containing a brief description why the nominee should be considered for membership;

(2) Short biography of nominee including credentials;

(3) Brief description of the U.S. company or U.S. organization to be represented and its activities and size (number of employees or members and annual sales, if applicable); and

(4) An affirmative statement that the applicant meets all Committee eligibility requirements for representative members, including that the applicant represents a U.S. company or U.S. organization.

a. For purposes of Committee eligibility, a U.S. company is at least 51 percent owned by U.S. persons.

b. For purposes of Committee eligibility, a U.S. organization is controlled by U.S. persons, as determined based on its board of directors (or comparable governing body), membership, and funding sources, as applicable.

In addition to the above requirements for all nominations, nominations for experts from academia should also provide the following information:

(1) A description of the nominee's area(s) of expertise;

(2) A concise Curriculum Vitae (CV) or resume that covers education, experience, and relevant publications and summarizes how this expertise addresses supply chain competitiveness;

(3) An affirmative statement that the applicant meets all Committee eligibility requirements.

Please do not send company or organization brochures.

Nominations may be emailed to [email protected], faxed to the attention of Richard Boll at 202-482-2669, or mailed to Richard Boll, Office of Supply Chain, Professional & Business Services, Room 11014, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, and must be received on or before January 12, 2018. Nominees selected for appointment to the Committee will be notified.

The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.

Domestic Toll Free: 1-866-844-9416.

International Toll and Toll Free: Will be posted on the CFTC's website, http://www.cftc.gov, on the page for the meeting, under Related Links.

Pass Code/Pin Code: 3599656.

The meeting agenda may change to accommodate other TAC priorities. For agenda updates, please visit the TAC committee site at: http://www.cftc.gov/About/CFTCCommittees/TechnologyAdvisory/tac_meetings.

After the meeting, a transcript of the meeting will be published through a link on the CFTC's website, http://www.cftc.gov. All written submissions provided to the CFTC in any form will also be published on the CFTC's website. Persons requiring special accommodations to attend the meeting because of a disability should notify the contact person above.

This committee's charter is being amended in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The amended charter and contact information for the Designated Federal Officer (DFO) can be obtained at http://www.facadatabase.gov/.

The DoD is amending the charter for the Defense Policy Board previously announced in the Federal Register on September 5, 2017 (82 FR 41941). Specifically, the DoD is amending the charter to update the estimated annual operating costs and estimated personnel costs and the total membership of the Defense Policy Board.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-51 with attached Policy Justification and Sensitivity of Technology.

NACIQI's Statutory Authority and Functions

NACIQI is established under Section 114 of the HEA, and is composed of 18 members appointed—

(A) On the basis of the individuals' experience, integrity, impartiality, and good judgment;

(B) From among individuals who are representatives of, or knowledgeable concerning, education and training beyond secondary education, representing all sectors and types of institutions of higher education; and,

(C) On the basis of the individuals' technical qualifications, professional standing, and demonstrated knowledge in the fields of accreditation and administration of higher education.

NACIQI meets at least twice a year and advises the Secretary of Education with respect to:

• The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2 of part G of Title IV of the HEA;

• The recognition of specific accrediting agencies or associations;

• The preparation and publication of the list of nationally recognized accrediting agencies and associations;

• The eligibility and certification process for institutions of higher education under Title IV of the HEA and part C of subchapter I of chapter 34 of Title 42, together with recommendations for improvements in such process;

• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions; and

• Any other advisory functions relating to accreditation and institutional eligibility that the Secretary of Education may prescribe by regulation.

The term of office of each member is six years. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term.

The current members of the NACIQI are:

• Simon J. Boehme (Student Member), Independent Consultant, San Francisco, California.

• Roberta L. Derlin, Ph.D., Associate Provost Emeritus, New Mexico State University, Albuquerque, New Mexico.

• John Etchemendy, Ph.D., Provost Emeritus, Stanford University, Stanford, California.

• Susan D. Phillips, Ph.D., Professor, University at Albany/SUNY and Leadership Fellow, SAIL Institute, Albany, New York.

• Frank H. Wu, J.D., Distinguished Professor, University of California Hastings College of Law, San Francisco, California.

• Federico Zaragoza, Ph.D., Vice Chancellor for Economic and Workforce Development, Alamo Colleges, San Antonio, Texas.

• Kathleen Sullivan Alioto, Ed.D., Strategic Advisor, Fundraiser, and Consultant, New York, New York, San Francisco, California, and Boston, Massachusetts.

• George T. French, Jr., Ph.D., President, Miles College, Fairfield, Alabama.

• Brian W. Jones, J.D., President, Strayer University.

• Arthur E. Keiser, Ph.D., Chancellor, Keiser University, Fort Lauderdale, Florida.

• Arthur J. Rothkopf, J.D., President Emeritus, Lafayette College, Washington, DC.

• Ralph Wolff, J.D., President, The Quality Assurance Commons for Higher and Postsecondary Education, Oakland, California.

• Jill Derby, Ph.D., Senior Consultant, Association of Governing Boards of Universities and Colleges, Gardnerville, Nevada.

• Paul J. LeBlanc, Ph.D., President, Southern New Hampshire University, Manchester, New Hampshire.

• Anne D. Neal, J.D., Senior Fellow, American Council of Trustees and Alumni, Washington, DC.

• Richard F. O'Donnell, Founder and CEO, Skills Fund, Austin, Texas.

• Claude O. Pressnell, Jr., Ed.D., President, Tennessee Independent Colleges and Universities Association.

• Steven Van Ausdle, Ph.D., President Emeritus, Walla Walla Community College, Walla Walla, Washington.

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 Adobe 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.

Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior executive.

Members of the 2017 EPA Performance Review Board are:

Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

ICR status: OMB approval for this ICR expired on July 1, 2017, due to administrative error. This action is a request to reinstate OMB approval for the information collection activities outlined in this document. Under PRA, 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 currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: This information collection program is designed to provide the EPA with assurances that the packaging of pesticide products sold and distributed to the general public in the United States meets standards set forth by the Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants of such pesticide products must certify to the Agency that the packaging or device meets these standards, in order to protect children and adults from serious illness or injury resulting from accidental ingestion or contact. The law requires that these standards are designed to be consistent with those under the Poison Prevention Packaging Act, administered by the Consumer Product Safety Commission (CPSC). Unless a pesticide product qualifies for an exemption, if the product meets certain criteria regarding toxicity and use, it must be sold and distributed in child-resistant packaging (CRP). The authority for this information collection is pursuant to Section 25(c)(3) of the FIFRA.

Respondents/affected entities: Respondents include entities involved in manufacturing of pesticide chemicals, wholesale merchandising of pesticide products, or pest management activities who submit CRP applications. The North American Industrial Classification System (NAICS) codes for respondents under this ICR include 325320 (Pesticide and other Agricultural Chemical Manufacturing), 424690 (Other Chemical and Allied Products Merchant Wholesalers), and 561710 (Exterminating and Pest Control Services). EPA recognizes that this list may not be comprehensive.

Respondent's obligation to respond: Mandatory.

Estimated number of respondents: 31 (total).

Frequency of response: On occasion.

Estimated total burden: 3,535 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Estimated total cost: $249,292 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the Estimates: There is a decrease of 1,972 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease reflects EPA's updating of burden estimates for this collection, including an increase in the estimated burden per response, and a decrease in the number of responses per year. This change is an adjustment.

Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

ICR status: OMB approval for this ICR expired on September 1, 2016, due to administrative error. This action is a request to reinstate OMB approval for the information collection activities outlined in this document. Under PRA, 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 currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: Section 4 of the Toxic Substances Control Act (TSCA) is designed to assure that chemicals that may pose serious risks to human health or the environment undergo testing by manufacturers or processors, and that the results of such testing are made available to EPA. EPA uses the information collected under the authority of TSCA section 4 to assess risks associated with the manufacture, processing, distribution, use or disposal of a chemical, and to support any necessary regulatory action with respect to that chemical.

EPA must assure that appropriate tests are performed on a chemical if it decides: (1) That a chemical being considered under TSCA section 4(a) may pose an “unreasonable risk” or is produced in “substantial” quantities that may result in substantial or significant human exposure or substantial environmental release of the chemical; (2) that additional data are needed to determine or predict the impacts of the chemical's manufacture, processing, distribution, use or disposal; and (3) that testing is needed to develop such data. Rules and consent orders under TSCA section 4 require that one manufacturer or processor of a subject chemical perform the specified testing and report the results of that testing to EPA. TSCA section 4 also allows a manufacturer or processor of a subject chemical to apply for an exemption from the testing requirement if that testing will be or has been performed by another party. This information collection applies to reporting and recordkeeping activities associated with the information that EPA requires industry to provide in response to TSCA section 4 test rules, consent orders, test rule exemptions and other data submissions.

Respondents/affected entities: Entities potentially affected by this ICR are manufacturers, processors, importers, users, distributors or disposers of one or more specified chemical substances.

Respondent's obligation to respond: Mandatory (see 40 CFR part 790).

Estimated number of respondents: 15 (total).

Frequency of response: On occasion.

Total estimated burden: 3,127 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $9,232,952 (per year), includes $9,010,065 annualized capital investment or maintenance and operational costs.

Changes in the estimates: There is a decrease of 626,766 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease reflects EPA's corrections to the previous renewal of this collection, plus reduced levels of activity in test rules, methodological corrections and updates, and requirements for electronic reporting of information. This change is both the result of a program change (electronic reporting) and an adjustment (all other factors).

I. Information About the Document

Section 108(a) of the Clean Air Act directs the Administrator to identify certain pollutants which, among other things, “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare” and to issue air quality criteria for them. These air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air . . . .” Under section 109 of the Act, EPA is then to establish NAAQS for each pollutant for which EPA has issued criteria. Section 109(d) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. EPA is also required to periodically review and, if appropriate, revise the NAAQS, based on the revised air quality criteria (for more information on the NAAQS review process, see https://www.epa.gov/naaqs).

Sulfur oxides are one of six criteria pollutants for which EPA has established NAAQS. Periodically, EPA reviews the scientific basis for these standards by preparing an ISA (formerly called an Air Quality Criteria Document). The ISA provides a comprehensive review, synthesis, and evaluation of the most policy-relevant science to serve as the scientific foundation for EPA's review of the current primary NAAQS for SOX. The Clean Air Scientific Advisory Committee (CASAC), an independent science advisory committee whose review and advisory functions are mandated by Section 109(d)(2) of the Clean Air Act, is charged (among other things) with independent scientific review of the EPA's air quality criteria.

On May 10, 2013 (78 FR 27387), EPA formally initiated its current review of the air quality criteria for the health effects of sulfur oxides and the primary (health-based) NAAQS for SOX, requesting the submission of recent scientific information on specified topics. EPA held a workshop on June 12-13, 2013, to gather input from invited scientific experts, both internal and external to EPA, as well as from the public, regarding key science and policy issues relevant to the review of the health effects of sulfur oxides and the primary NAAQS for SOX (78 FR 27387). These science and policy issues were incorporated in EPA's “Integrated Review Plan for the Primary National Ambient Air Quality Standard for Sulfur Dioxide” (EPA-452/R-14-007), which was finalized in October 2014 (79 FR 66721) with a prior draft available for public comment (79 FR 14035) and discussion by the CASAC via publicly accessible teleconference consultations (79 FR 16325, 79 FR 30137, 79 FR 34739). On June 23-24, 2014, EPA held a workshop to discuss, with invited internal and external scientific experts, initial draft materials prepared in the development of the ISA (79 FR 33750). EPA considered comments on these draft materials in preparing the first external review draft of the ISA, which was released on November 24, 2015 (80 FR 73183). The first draft ISA was discussed at a public CASAC meeting on January 27-28, 2016 (80 FR 79330). Subsequently, on April 15, 2016, the CASAC provided a consensus letter to the EPA Administrator summarizing their review (https://yosemite.epa.gov/sab/sabproduct.nsf/4620a620d0120f93852572410080d786/8DEC36A7E2A54BA485257F9600667D81/$File/EPA-CASAC+2016-002+Unsigned.pdf). The second draft ISA was then developed with consideration of comments from the CASAC and the public, and includes consideration of scientific studies published through September 2016 (81 FR 89097). The CASAC panel met at a public meeting on March 20-21, 2017, to review the second draft ISA (82 FR 11449). Subsequently, on June 30, 2017, the CASAC provided a consensus letter for their review to the EPA Administrator (https://yosemite.epa.gov/sab/sabproduct.nsf/4620a620d0120f93852572410080d786/88CD26BC35A8C8688525814F004D86EC/$File/EPA-CASAC-17-003.pdf). The letters from CASAC, as well as public comments received on the ISA drafts, can be found in Docket ID No. EPA-HQ-ORD-2013-0357.

EPA has considered comments by the CASAC panel and by the public in preparing this final ISA.

EXECUTIVE ORDER 12866: This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

ICR status: This ICR expire on August 31, 2016. Under PRA, 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 currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: EPA's Safer Choice program formally recognizes safer products where all ingredients have an environmental and human health profile showing that they are the safest in their functional use class. Under the encouragement of this program, leading companies have made great progress in developing safer, highly effective chemical products. Since the program's inception in 1997, formulators have used the program as a portal to EPA's unique chemical expertise, information resources, and guidance on greener chemistry. Safer Choice program partners enjoy Agency recognition, including the use of the Safer Choice program logo on products with the safest possible formulations. In the future, EPA expects much greater program participation due to rising demand for safer products. This information collection enables EPA to accommodate participation by more than nine formulators each year and to enhance program transparency.

Information collection activities associated with this program will assist the Agency in meeting the goals of the Pollution Prevention Act (PPA) by providing resources and recognition for businesses committed to promoting and using safer chemical products. In turn, the program will help businesses meet corporate sustainability goals by providing the means to, and an objective measure of, environmental stewardship. Investment analysts and advisers seek these types of measures in evaluating a corporation's sustainability profile and investment worthiness. Safer Choice Product Recognition program partnership is an important impetus for prioritizing and completing the transition to safer chemical products. The Safer Choice Product Recognition program is also needed to promote greater use of safer chemical products by companies unaware of the benefits of such a change.

EPA has tailored its request for information, and especially the Safer Choice Product Recognition program application forms, to ensure that the Agency requests only that information essential to verify applicants' eligibility for recognition.

Respondents/Affected Entities: Companies engaged in the formulation of end-use, for-sale products that have furthered the goals of the Safer Choice program through participation in and promotion of the program, and that wish to receive recognition for their achievements.

Respondent's obligation to respond: Responses to the collection of information are voluntary. Respondents may claim all or part of a response confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

Estimated total number of potential respondents: 157.

Frequency of response: On occasion.

Estimated total burden: 1,596 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Estimated total costs: $ 652,359 (per year), includes no annualized capital investment or maintenance and operational costs.

Changes in the estimates: There is an increase of 362 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This increase reflects EPA's estimate of a greater number of respondents, due to historical experience and increases in the expected future number of responses due to greater consumer awareness and demand for products with the Safer Choice label. This increase is partially offset by reduced per-response burden estimates based on expected efficiencies created by using the Salesforce-based Safer Choice Community on the part of respondents. This change is an adjustment.

In this review cycle, GSA will be directly contacting representatives of systems that have passed GSA's screening criteria, described below, to request completion of a survey designed to provide GSA with detailed information about the identified system, in order to support its data collection process.

Systems deemed to meet all of the criteria will be evaluated in detail. GSA's screening criteria follow:

1. The certification system is currently available for use in the U.S. commercial buildings market and is not limited to one climate zone or geographic region.

2. The certification system addresses buildings (rather than individual products) with multiple performance and sustainable design attributes identified in EISA, including (but not limited to) energy, water, natural resources and environmental quality.

3. The certification system is validated by an independent, third-party assessor.

4. The certification system incorporates (where feasible), measurable and/or calculated metrics to assess building performance as opposed to evidence of intent.

GSA will request input from representatives of certification systems meeting the above screening criteria, to better inform its recommendation to the Secretary of Energy on what certification system(s) best meet(s) the requirements described in Section 436 of EISA.

GSA will provide the findings from its evaluation and set of recommendations to the Secretary of Energy who, in consultation with the Department of Defense and GSA, may identify the system(s) to recommend for use across the Federal Government.

Additional information can be found online at: http://www.gsa.gov/gbcertificationreview

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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, including the validity of the methodology and assumptions used;

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, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communications Campaigns—(OMB No. 0920-0800, exp. 12/31/2017)—Reinstatement without Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

The mission of the CDC's Division of Cancer Prevention and Control (DCPC) is to reduce the burden of cancer in the United States through cancer prevention, reduction of risk, early detection, better treatment, and improved quality of life for cancer survivors. Toward this end, the DCPC supports the scientific development and implementation of various health communication campaigns with an emphasis on specific cancer burdens.

This process requires testing of messages, concepts, and materials prior to their final development and dissemination, as described in the second step of the health communication process. The health communication process is a scientific model developed by the U.S. Department of Health and Human Services' National Cancer Institute to guide sound campaign development. The communication literature supports various data collection methods, one of which is focus groups, to conduct credible formative, concept, message, and materials testing. The purpose of focus groups is to ensure that the public and other key audiences, like health professionals, clearly understand cancer-specific information and concepts, are motivated to take the desired action, and do not react negatively to the messages.

CDC is currently approved to collect information needed to plan and tailor cancer communication campaigns (OMB No. 0920-0800, expiration date 12/31/2017), and seeks OMB approval to extend the existing generic clearance.

Information collection will involve focus groups to assess numerous qualitative dimensions of cancer prevention and control messages including, but not limited to, cancer knowledge, attitudes, beliefs, behavioral intentions, information needs and sources, clinical practices (among healthcare providers), and compliance with recommended cancer screening. Insights gained from the focus groups will assist in the development and/or refinement of future campaign messages and materials.

Respondents will include healthcare providers as well as members of the general public. Communication campaigns and messages will vary according to the type of cancer, the qualitative dimensions of the message described above, and the type of respondents.

DCPC plans to conduct or sponsor up to 80 focus groups per year over a three-year period. An average of 10 respondents will participate in each focus group discussion. DCPC has developed a set of example questions that can be used to develop a discussion guide for each focus group activity. The average burden for response for each focus group will be two hours. DCPC has also developed a set of example questions that can be tailored to screen for targeted groups of respondents. The average burden per response for screening and recruitment is three minutes.

A separate information collection request will be submitted to OMB for approval of each focus group activity. The request will describe the purpose of the activity and include the customized information collection instruments.

OMB approval is requested for three years. There are no changes to information collection purpose or methodology. Participation is voluntary and there are no costs to respondents except their time.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help:

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, including the validity of the methodology and assumptions used;

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, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

National Vital Statistics Report Forms (OMB Control Number 0920-0213, expires 04/30/2018)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

The compilation of national vital statistics dates back to the beginning of the 20th century and has been conducted since 1960 by the Division of Vital Statistics of the National Center for Health Statistics, CDC. The collection of the data is authorized by 42 U.S.C. 242k. This submission requests approval to collect the monthly and annually summary statistics for three years.

The Monthly Vital Statistics Report forms provide counts of monthly occurrences of births, deaths, and infant deaths. Similar data have been published since 1937 and are the sole source of these data at the National level. The data are used by the Department of Health and Human Services and by other government, academic, and private research and commercial organizations in tracking changes in trends of vital events. Respondents for the Monthly Vital Statistics Reports Form are registration officials in each State and Territory, the District of Columbia, and New York City. This form is also designed to collect counts of monthly occurrences of births, deaths, and infant deaths immediately following the month of occurrence.

The Annual Vital Statistics Occurrence Report Form collects final annual counts of marriages and divorces by month for each State and Territory, the District of Columbia, and New York City as well as 33 counties in New Mexico. These final counts are usually available from State or county officials about eight months after the end of the data year. The data are widely used by government, academic, private research, and commercial organizations in tracking changes in trends of family formation and dissolution.

There are no costs to respondents other than their time.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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, including the validity of the methodology and assumptions used;

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, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Message Testing for Tobacco Communication Activities (MTTCA)(OMB Control Number 0920-0910, expires 03/31/2018)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

In 2012, CDC's Office on Smoking and Health obtained OMB approval of a generic clearance plan to support the development and testing of tobacco-related health messages, including messages disseminated through multiple phases of a media campaign (Message Testing for Tobacco Communication Activities (MTTCA), OMB No. 0920-0910, expiration 1/31/2015). In 2014, OSH obtained approval for a modification to the MTTCA clearance that granted a three-year extension and an increase in respondents and burden hours (MTTCA, OMB Control Number 0920-0910, exp. 3/31/2018). This MTTCA clearance was approved with 44,216 annualized responses and 10,998 annualized burden hours. CDC's authority to collect information for public health purposes is provided by the Public Health Service Act (41 U.S.C. 241) Section 301.

CDC has employed the MTTCA data collection plan to collect information about adult smokers' and nonsmokers' attitudes and perceptions, and to pretest draft messages and materials for clarity, salience, appeal, and persuasiveness. The MTTCA clearance has been used to obtain OMB approval for a variety of message testing activities, with particular emphasis on communications supporting CDC's National Tobacco Education Campaign (NTEC) called the Tips from Former Smokers® campaign. This national campaign is designed to increase public awareness of the health consequences of tobacco use and exposure to secondhand smoke. The MTTCA clearance has also supported formative research relating to the development of health messages that are not specifically associated with the national campaign.

Information collection modes under the MTTCA plan that are supported include in-depth interviews; in-person focus groups; online focus groups; computer-assisted, in-person, or telephone interviews; and online surveys. Each project approved under the MTTCA framework is outlined in a project-specific Information Collection Request that describes its purpose and methodology. Messages developed from MTTCA data collection have been disseminated via multiple media channels including television, radio, print, out-of-home, and digital formats.

CDC requests OMB approval to extend the MTTCA generic information collection plan, without changes, for three years. No modification is requested for information collection activities, methodology, respondents, or burden from the existing generic clearance. The extension is needed to support CDC's planned information collections and to accommodate additional needs that CDC may identify during the next three years. For example, the MTTCA generic plan may be used to facilitate the development of tobacco-related health communications of interest for CDC's collaborative efforts with other federal partners including, but not limited to, the Food and Drug Administration's Center for Tobacco Products. At this time, the respondents and burden outlined in the existing MTTCA clearance are expected to be sufficient to test tobacco related messages developed by CDC for the general U.S. population and subpopulations of interest. The MTTCA clearance should not replace the need for additional generic clearance mechanisms of HHS and other federal partners that may need to test tobacco messages related to their campaigns and initiatives.

The existing MTTCA clearance was granted approval for a total of 132,648 respondents and 32,994 burden hours over a three-year period (annualized number of respondents of 44,216 and annualized burden hours to 10,998). To date, there have been 57,612 respondents and 10,515 burden hours used for this project, leaving a balance of 75,036 respondents and 22,479 burden hours (annualized number of respondents of 25,012 and annualized burden hours to 7,256 for each of the three years in the requested extension).

CDC will continue to use the MTTCA clearance to develop and test messages and materials. Participation is voluntary and there are no costs to respondents, other than their time.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

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. The term “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 requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Hospice Conditions of Participation; Use: The Conditions of Participation and accompanying requirements are used by Federal or State surveyors as a basis for determining whether a hospice qualifies for approval or re-approval under Medicare. The healthcare industry and CMS believe that the availability to the hospice of the type of records and general content of records, which the final rule (72 FR 32088) specifies, is standard medical practice, and is necessary in order to ensure the well-being and safety of patients and professional treatment accountability. Form Number: CMS-10277 (OMB control number: 0938-1067); Frequency: Reporting and Recordkeeping—Yearly; Affected Public: Private sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 4,473; Total Annual Responses: 19,769,931; Total Annual Hours: 6,074,745. (For policy questions regarding this collection contact Mary Rossi-Coajou at 410-786-6051.)

Under the Paperwork Reduction Act of 1995 (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. The term “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 publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions; Use: State Medicaid and CHIP agencies are responsible for developing submissions to CMS, including state plan amendments and requests for waivers and program demonstrations. States use templates when they are available and submit the forms to review for consistency with statutory and regulatory requirements (or in the case of waivers and demonstrations whether the proposal is likely to promote the objectives of the Medicaid program). If the requirements are met, we approve the states' submissions giving them the authority to implement the flexibilities. For a state to receive Medicaid Title XIX funding, there must be an approved Title XIX state plan.

The development of streamlined submissions forms enhances the collaboration and partnership between states and CMS by documenting our policy for states to use as they are developing program changes. Streamlined forms improve efficiency of administration by creating a common and user-friendly understanding of the information we need to quickly process requests for state plan amendments, waivers, and demonstration, as well as ongoing reporting. Form Number: CMS-10398 (OMB control number: 0938-1148); Frequency: Collection-specific, but generally the frequency is yearly, once, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Responses: 1,540 (3-year total); Total Hours: 214,584 (3-year total). (For policy questions regarding this collection contact Annette Pearson at 410-786-6858.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Contract Year 2019 Plan Benefit Package (PBP) Software and Formulary Submission; Use: We require that Medicare Advantage and Prescription Drug Plan organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to us for review and approval. We publish beneficiary education information using a variety of formats. The specific education initiatives that utilize PBP and formulary data include web application tools on www.medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information. Form Number: CMS-R-262 (OMB control number 0938-0763); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 520; Total Annual Responses: 5,675; Total Annual Hours: 53,600. (For policy questions regarding this collection contact Kristy Holtje at 410-786-2209.)

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Refuse to File: NDA and BLA Submissions to CDER.” The purpose of this guidance is to clarify certain circumstances under which CDER may refuse to file an NDA or supplemental NDA, or a BLA or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of an RTF action by FDA. Since the early 1990s, in conjunction with the Prescription Drug User Fee Act, FDA's processes and timelines for reviewing newly submitted applications have substantially evolved. The administrative complexity of applications, with corresponding determinations of completeness, has become more challenging. The overall goal is to efficiently and effectively review applications, and thus it is critical to avoid use of resources to review an application when necessary components are so deficient as to render the application incomplete. FDA exercises its RTF authority for incomplete applications to optimize the use of both the applicant's and FDA's resources.

Incomplete applications, including applications for which minor components not received within 30 calendar days after receipt of the original application, as may have been agreed upon at a presubmission meeting, may be refused for filing.

This guidance focuses on FDA's policy for refusing to file an NDA under 21 CFR 314.101(d)(3) because the NDA is incomplete because it does not on its face contain information required under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and 21 CFR 314.50. FDA considers incompleteness to be a basis for refusal to file for BLAs as well (21 CFR 601.2(a)).

On May 19, 2017, FDA withdrew its previously published guidance for industry entitled “Refusal to File” (issued July 12, 1993). FDA is issuing this guidance to update and clarify CDER's procedures for determining whether an application should be refused for filing because it is incomplete. This guidance includes procedures for certain BLAs and supplemental BLAs, given that CDER has regulatory responsibility for certain therapeutic biological products subject to licensing under the Public Health Service Act.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on refusal to file NDA and BLA submissions to CDER. 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.

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

I. Background

Antimicrobial susceptibility testing is used to determine if certain microorganisms that are isolated from a patient with an infection are likely to be killed or inhibited by a particular antimicrobial drug. It is important that the in vitro susceptibility test methods and susceptibility test interpretive criteria for systemic antibacterial or antifungal drugs be reviewed on a regular basis and updated to reflect the most current information. The development of new mechanisms of resistance in bacteria or fungi may result in decreased susceptibility to a particular drug. Decreased susceptibility may raise efficacy or safety concerns when out-of-date susceptibility test interpretive criteria are used in guiding the treatment of patients.

Historically, susceptibility test interpretive criteria have been contained in the Microbiology subsection of antimicrobial drug labeling, and there have been significant challenges associated with ensuring that this information is up-to-date in individual antimicrobial drug labels. For some time, FDA and other stakeholders have recognized that susceptibility test interpretive criteria standards established by nationally or internationally recognized standard development organizations (SDOs) can be useful sources of information to identify and update susceptibility test interpretive criteria.

Section 511A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360a-2), as added by section 3044 of the Cures Act (Pub. L. 114-255), was signed into law on December 13, 2016. This provision clarifies FDA's authority to identify and efficiently update susceptibility test interpretive criteria, including through the recognition by FDA of standards established by SDOs. It also clarifies that sponsors of AST devices may rely upon listed susceptibility interpretive criteria to support premarket authorization of their devices, provided they meet certain conditions, which provides for a more streamlined process for incorporating up-to-date information into such devices.

Section 511A of the FD&C Act requires FDA to establish within 1 year after the date of enactment of the Cures Act an Interpretive Criteria Website that contains a list of FDA-recognized susceptibility test interpretive criteria standards, as well as other susceptibility test interpretive criteria identified by FDA. FDA is announcing the establishment of this Interpretive Criteria Website, which can be found here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm.

This website recognizes susceptibility test interpretive criteria established by an SDO that fulfills the requirements under section 511A(b)(2)(A) of the FD&C Act; identifies when FDA does not recognize, in whole or in part, susceptibility test interpretive criteria established by an SDO; and lists susceptibility test interpretive criteria identified by FDA outside the SDO process. The susceptibility test interpretive criteria listed by FDA on the Interpretive Criteria Website are deemed to be recognized as a standard under section 514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)).

At least every 6 months after the establishment of the Interpretive Criteria Website, FDA will publish on the Interpretive Criteria Website a notice recognizing new or updated susceptibility test interpretive criteria standards, or parts of standards; withdrawing recognition of susceptibility test interpretive criteria standards, or parts of standards; and making any other necessary updates to the lists published on the Interpretive Criteria Website. Once a year FDA will compile the notices from that year and publish them in the Federal Register and provide for public comment. If comments are received, FDA will review those comments and make any updates to the recognized standards or susceptibility test interpretive criteria as needed. In addition to this statutorily required annual notice, FDA intends to publish a Federal Register notice within the next few months to allow for public comment on the initial recognition of susceptibility test interpretive criteria.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Gluten in Drug Products and Associated Labeling Recommendations.” This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. Confronted by uncertainty, some patients may forego important medication rather than risk an adverse reaction to gluten. Thus, even if gluten is not present at levels that would harm a typical individual with celiac disease, that individual may be harmed through uncertainty and lack of information.

Celiac disease is an immune-based reaction to dietary gluten that primarily affects the small intestine in susceptible individuals; unmanaged celiac disease can lead to serious health complications. Approximately 1 percent of the U.S. population has celiac disease (Binder, 2015, “Disorders of Absorption,” in Harrison's Principles of Internal Medicine, 19th ed.). It is characterized by ongoing inflammation of part of the lining of the small intestine that generally heals if foods containing gluten are excluded from the diet and returns if they are reintroduced. This guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals. Manufacturers should pay attention to possible sources of gluten in their products, consider specifications when appropriate, and consider the impact of changes in ingredient sources or formulations on gluten content.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Gluten in Drug Products and Associated Labeling Recommendations. 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.

This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information discussed in the draft guidance have been approved by OMB under the following control numbers:

OMB control number 0910-0001: Submitting to FDA labeling in NDAs and ANDAs, including amendments to pending NDAs and ANDAs, supplements to approved NDAs and ANDAs, and annual reports; OMB control number 0910-0572: Designing, testing, and revising prescription drug product labeling; OMB control number 0910-0340: Designing, testing, and revising Drug Facts labeling for OTC drugs, including submitting labeling to FDA for OTC monograph drugs; OMB control number 0910-0139: Recordkeeping requirements in CGMPs; OMB control number 0910-0393: Preparing and revising Medication Guides; and OMB control number 0910-0338: Submitting to FDA labeling in BLAs, including amendments to pending BLAs, supplements to approved BLAs, and annual reports.

The recommended labeling statement in this draft guidance, “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)” is information provided by FDA to applicants and manufacturers for disclosure to the public and therefore does not constitute a collection of information under 5 CFR 1320.3(c)(2).

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

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 above captioned Agency guidance document. FDA recommends that producers who use biotechnology in the manufacture or development of foods and food ingredients work cooperatively with FDA to ensure that products derived through biotechnology are safe and comply with all applicable legal requirements and has instituted a voluntary consultation process with industry. To facilitate this process, the Agency has issued a guidance entitled, “Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,” which is available on our website at https://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation process for the evaluation of information on new plant varieties provided by developers. The Agency believes this consultation process will help ensure that human food and animal feed safety issues or other regulatory issues (e.g. labeling) are resolved prior to commercial distribution. Additionally, such communication will help to ensure that any potential food safety issues regarding a new plant variety are resolved during development, and will help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the standards of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Since 1992, when FDA issued its “Statement of Policy: Foods Derived From New Plant Varieties” (the 1992 policy) (57 FR 22984, May 29, 1992), FDA has encouraged developers of new plant varieties, including those varieties that are developed through biotechnology, to consult with FDA during the plant development process to discuss possible scientific and regulatory issues that might arise. In the 1992 policy, FDA explained that, under the FD&C Act, developers of new foods (in this document food refers to both human food and animal feed) have a responsibility to ensure that the foods they offer to consumers are safe and in compliance with all requirements of the FD&C Act (57 FR 22984 at 22985).

Description of Respondents: Respondents to this collection of information include developers of new plant varieties intended for food use.

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

We have retained the currently approved burden estimate for this information collection and discuss the information collection activities below.

Initial consultations are generally a one-time burden, although a developer might return more than once to discuss additional issues before submitting a final consultation. As noted in the guidance, FDA encourages developers to consult early in the development phase of their products, and as often as necessary. Historically, firms developing a new bioengineered plant variety intended for food use have generally initiated consultation with FDA early in the process of developing such a variety, even though there is no legal obligation for such consultation. These consultations have served to make FDA aware of foods and food ingredients before these products are distributed commercially, and have provided FDA with the information necessary to address any potential questions regarding the safety, labeling, or regulatory status of the food or food ingredient. As such, these consultations have provided assistance to both industry and the Agency in exercising their mutual responsibilities under the FD&C Act.

FDA estimates that its Center for Veterinary Medicine and its Center for Food Safety and Applied Nutrition jointly received an average of 40 initial consultations per year in the last 3 years via telephone, email, or written letter. Based on this information, we expect to receive no more than 40 annually in the next 3 years.

Final consultations are a one-time burden. At some stage in the process of research and development, a developer will have accumulated the information that the developer believes is adequate to ensure that food derived from the new plant variety is safe and that it demonstrates compliance with the relevant provisions of the FD&C Act. The developer will then be in a position to conclude any ongoing consultation with FDA. The developer submits to FDA a summary of the safety and nutritional assessment that has been conducted about the bioengineered food that is intended to be introduced into commercial distribution. FDA evaluates the submission to ensure that all potential safety and regulatory questions have been addressed. FDA has developed a form that prompts a developer to include certain elements in the final consultation in a standard format: Form FDA 3665 entitled, “Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation).” The form, and elements that would be prepared as attachments to the form, can be submitted in electronic format.

We base our estimate of the average time to prepare a submission on informal contact with firms that made one or more biotechnology consultation submission under the voluntary biotechnology consultation process. As such, we estimate the average time to prepare a submission for final consultation to be 150 hours.

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

This information collection supports Agency outreach efforts. Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews, all on a voluntary basis. The methods to be used serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative research tool, have two major purposes: To obtain information that is useful for developing variables and measures for formulating the basic objectives of risk communication campaigns, and to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences.

FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies. FDA will use this mechanism to test messages about regulated drug products on a variety of subjects related to consumer, patient, or health care professional perceptions and about use of drug products and related materials, including but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, medication guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sale of medical products, and consumer and professional education. Annually, FDA projects about 45 communication studies using the variety of test methods listed in this document. FDA is requesting an extension of these burden hours so as not to restrict the Agency's ability to gather information on public sentiment for its proposals in its regulatory and communications programs.

In the Federal Register of June 19, 2017 (82 FR 27840), we published a 60-day notice requesting public comment on the proposed extension of the collection of information. One comment was received requesting that FDA publish an annual list of its planned drug product communication studies and strive to reflect an overall work plan. The comment also noted the rather broad topic areas included in the information collection and suggested that perhaps additional notice regarding individual studies would allow for more meaningful feedback on whether that particular study would be necessary. FDA appreciates this comment. In determining which drug product communications it will undertake, we first consider those we believe will best address current or immediate public health issues. We also note that, in accordance with the PRA, any proposed study under this information collection request must first be submitted to and approved by OMB to determine whether it falls within the scope of the collection. At the same time, as resources are available, we will make every effort to communicate to our stakeholders anticipated studies so that ongoing or related research can be coordinated.

We therefore estimate the burden of this collection of information as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.

The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.

FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.

The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://www.fema.gov/preliminaryfloodhazarddata and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.

The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://www.fema.gov/preliminaryfloodhazarddata and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

The National Flood Insurance Program (NFIP), codified at 42 U.S.C. 4001, et seq., requires all flood prone communities throughout the country to apply for participation in the NFIP one year after their flood prone status is identified or submit to the prohibition of certain types of federal and federally-related financial assistance for use in their floodplains. Title 44 Code of Federal Regulations (CFR) section 59.2 authorizes previously unavailable flood insurance protection to property owners in flood-prone areas, and 44 CFR 59.22 identifies the information that communities are required to submit to FEMA for application into the NFIP. 44 CFR 59.22 and 59.24 identify the information a community is required to submit to FEMA for continued participation in the program.

This information collection expired on September 30, 2017. FEMA is requesting a reinstatement, without change, of a previously approved information collection for which approval has expired.

Title: Application for Participation in the National Flood Insurance Program (NFIP).

Type of Information Collection: Reinstatement, without change, of a previously approved collection for which approval has expired.

OMB Number: 1660-0004.

Form Titles and Numbers: FEMA Form 086-0-30, Application for Participation in the National Flood Insurance Program.

Abstract: The National Flood Insurance Program (NFIP) provides flood insurance to the communities that apply for participation and make a commitment to protect against future flood damages. The application form and supporting documentation will enable FEMA to continue to rapidly process new community applications and to thereby more quickly provide flood insurance protection to the residents in communities.

To qualify for the NFIP, a participating community must adopt certain minimum standards in accordance with FEMA's regulations at 44 CFR 60.3, 60.4, and 60.5. In order to verify whether communities maintain such standards, the NFIP requires participating communities to retain documentation on development taking place in the flood hazard areas within the community. 44 CFR 59.22. Such information will be made available to FEMA upon request. This information assists FEMA in evaluating the effectiveness of a community's floodplain management program and participating property owners' eligibility for flood insurance.

This reinstatement does not propose any change in the information solicited from respondents through this information collection; however, the number of burden hours has been updated to reflect changing number of respondents and responses received through this collection over time. These changes have occurred naturally, and do not result from specific action taken by FEMA.

The “Application for Participation in the NFIP” and the “NFIP and the Community Development Permit Process” are separate actions documented under the same collection.

Affected Public: State, local or Tribal government.

Estimated Number of Respondents: 22,367.

Estimated Number of Responses: 97,724.

Estimated Total Annual Burden Hours: 244,418.

Estimated Total Annual Respondent Cost: $20,946,623.

Estimated Total Annual Cost to the Federal Government: $ 83,041.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) 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; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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 submission of responses.

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.

The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://www.fema.gov/preliminaryfloodhazarddata and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.