Federal Register Vol. 82, No.81,

Title: Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products.

OMB Control Number: 0579-0393.

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

Abstract: The Animal Health Protection Act (7 U.S.C. 8301 et seq.) authorizes the Secretary of Agriculture to, among other things, prohibit or restrict the importation and interstate movement of animals and animal products into or through the United States to prevent the introduction and dissemination of animal diseases and pests.

To guard against the introduction of animal diseases, the Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States. The regulations in 9 CFR parts 92, 93, 94, 95, and 96 govern the importation of certain animals, birds, poultry, meat, and other animal products and byproducts into the United States to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE), a chronic degenerative disease that affects the central nervous system of cattle.

Section 92.5 of the regulations provides that all countries of the world are considered by APHIS to be in one of three BSE risk categories: Negligible risk, controlled risk, or undetermined risk. These risk categories are defined in §  92.1. Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. Under the regulations, APHIS may classify a region for BSE in one of two ways. One way is for countries that have not received a risk classification from the World Organization for Animal Health (OIE) to request classification by APHIS. The other way is for APHIS to concur with the classification given to a country by the OIE.

To ensure BSE is not introduced into the United States, the regulations place specific conditions on the importation of animals and animal products. These requirements necessitate the use of several information collection activities, including, but not limited to, certifications, official identification, request for and retention of classification as negligible or controlled risk, declarations of importation, import and export certificates, applications, import and movement permits, agreements, certification statements, seals, notifications, and recordkeeping.

The information collection requirements above are currently approved by the Office of Management and Budget (OMB) under OMB control numbers 0579-0393 (Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products) and 0579-0234 (Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products). After OMB approves this combined information collection package (0579-0393), APHIS will retire OMB control number 0579-0234. We have also updated the title of this information collection to “Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products.”

We are asking the 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 reporting burden for this collection of information is estimated to average 0.52 hours per response.

Respondents: Shippers, hunters, U.S. importers of regulated animal products, herd owners (including hobby farms), salaried veterinarians of foreign nations, foreign exporters of processed animal protein and other regulated materials and products, accredited veterinarians, and slaughter facility managers.

Estimated annual number of respondents: 2,225.

Estimated annual number of responses per respondent: 238.

Estimated annual number of responses: 529,236.

Estimated total annual burden on respondents: 275,743 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.

Title: Importation of Ruminant and Swine Hides, Bird Trophies, and Deer Hides.

OMB Control Number: 0579-0307.

Type of Request: Reinstatement of an information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture is authorized, among other things, to prohibit or restrict the importation and interstate movement of animals and animal products to prevent the introduction into and dissemination within the United States of livestock diseases and pests. To carry out this mission, APHIS regulates the importation of animals and animal products into the United States. The regulations are contained in title 9, parts 91 through 99, of the Code of Federal Regulations (CFR).

The regulations in 9 CFR part 95 (referred to below as the regulations) prohibit or restrict the importation of specified animal products into the United States to prevent the introduction into the U.S. livestock population of certain contagious animal diseases. Sections 95.16 and 95.17 of the regulations contain, among other things, specific processing, recordkeeping, and certification requirements for untanned hides and skins and bird trophies.

The regulations require that shipments of hides be accompanied by certificates showing their origin and certifying that the hides are from areas free of certain animal diseases. Shipments of ruminant hides from Mexico must be accompanied by written statements indicating that the hides were frozen for 24 hours and treated for ticks. Shipments of bird trophies must be accompanied by certificates of origin certifying that the trophies are from regions free of exotic Newcastle disease and highly pathogenic avian influenza. These activities help ensure that the products do not harbor disease or ticks.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 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 reporting burden for this collection of information is estimated to average 0.2 hours per response.

Respondents: National government officials of the exporting country, owners of untanned ruminant and swine hides, and importers of untanned ruminant and swine hides.

Estimated number of respondents: 264.

Estimated number of responses per respondent: 2.59.

Estimated annual number of responses: 683.

Estimated total annual burden on respondents: 137 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 General Conference Committee (the Committee) of the National Poultry Improvement Plan, representing cooperating State agencies and poultry industry members, serves an essential function by acting as liaison between the poultry industry and the Department in matters pertaining to poultry health.

Topics for discussion at the upcoming meeting include:

1. National Veterinary Services Laboratories (NVSL) Avian Influenza Update.

2. Animal and Plant Health Inspection Service/Veterinary Services Update.

3. Compartmentalization Program for Primary Breeders.

4. NVSL Salmonella Update.

5. New Diagnostic Tests.

The meeting will be open to the public. However, due to time constraints, the public will not be allowed to participate in the discussions during the meeting. Written statements on meeting topics may be filed with the Committee before or after the meeting by sending them to the person listed under FOR FURTHER INFORMATION CONTACT. Written statements may also be filed at the meeting. Please refer to Docket No. APHIS-2017-0021 when submitting your statements.

This notice of meeting is given pursuant to section 10 of the Federal Advisory Committee Act (5 U.S.C. App. 2).

Title: Credit Account Approval for Reimbursable Services.

OMB Control Number: 0579-0055.

Type of Request: Extension of approval of an information collection.

Abstract: The Animal and Plant Health Inspection Service (APHIS) provides the services of a Federal inspector to clear imported and exported agricultural commodities for animal and plant health purposes. These services are paid for by user fees during regular working hours. If an importer wishes to have shipments cleared at other hours, such services will usually be provided on a reimbursable overtime basis, unless already covered by a user fee. Exporters wishing cargo to be certified during nonworking hours may also utilize this procedure.

Many importers and exporters who require inspection services are repeat customers who request that APHIS bill them. The Agency needs to collect certain information to conduct a credit check on prospective applicants to ensure creditworthiness prior to extending credit services and to prepare billings. Also, the Debt Collection Improvement Act of 1996, as amended (31 U.S.C. 3332), requires that agencies collect tax identification numbers from all persons doing business with the Government for purposes of collecting delinquent debts. APHIS Form 192 (Application for Credit Account) is used to collect this information and must be completed before credit is extended.

We are asking the Office of Management and Budget (OMB) to approve our use of this information collection activity 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 reporting burden for this collection of information is estimated to average 0.25 hours per response.

Respondents: Importers, exporters, or brokers who wish to set up an account for billing of inspection services provided during nonworking hours.

Estimated Annual Number of Respondents: 261.

Estimated Annual Number of Responses per Respondent: 1.

Estimated Annual Number of Responses: 261.

Estimated Total Annual Burden on Respondents: 65 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 purpose of this meeting is to provide:

1. Continued deliberations on formulating advice for the Secretary,

2. Discussion of Committee work group findings,

3. Hearing public comments, and

4. Administrative tasks.

This meeting is open to the public. The agenda will include time for people to make oral comments of three minutes or less. Individuals wishing to make an oral comment should submit a request in writing by May 5, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Committee may file written statements with the Committee's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Crystal Merica, USDA Forest Service, Ecosystem Management Coordination, 201 14th Street SW., Mail Stop 1104, Washington, DC 20250-1104, or by email at [email protected]. The agenda and summary of the meeting will be posted on the Committee's Web site within 21 days of the meeting.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is to provide:

(1) 2017 Recreation Event Permits;

(2) Information Topic: National Forest System Trails Stewardship Act;

(3) Black Hills Resilient Landscape Project update;

(4) Teckla Osage 230 kV Powerline Update;

(5) Non-motorized Trails—Working Group update; and

(6) Black Hills National Forest Mobile App;

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by May 8, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Board may file written statements with the Board's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Scott Jacobson, Black Hills National Forest Supervisor's Office, 1019 North Fifth Street, Custer, South Dakota 57730; by email to [email protected], or via facsimile to 605-673-9208.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). The Department published the notice of initiation of this investigation on December 22, 2017.1 On February 2, 2017, the Department postponed the preliminary determination of this investigation and the revised deadline is now April 24, 2017.2

On April 13, 2017, the Department preliminarily determined that critical circumstances exist with respect to certain companies.3 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.4 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and electronic versions of the Preliminary Decision Memorandum are identical in content.

The product covered by this investigation is softwood lumber from Canada. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to the Department's regulations,5 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage, (i.e., scope).6 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice as well as on additional language proposed by the Department. On March 29, 2017, a letter presenting a proposal for company exclusions was filed on behalf of the Government of Canada (GOC), Canadian provincial and territorial governments, as well as the Canadian industry associations.7 The Department finds that it lacks the authority to conduct the requested company exclusion process in the context of this countervailing duty investigation (CVD) on softwood lumber from Canada.8

With respect to other proposed scope exclusions, including the request to exclude merchandise from certain provinces, the Department is inviting comments on those proposed exclusions and will incorporate the decisions into the final CVD and AD determinations after considering any relevant comments submitted in case and rebuttal briefs. Comments on any proposed scope exclusions are due no later than seven days of publication of this notice in the Federal Register. Please note that the Department will not accept any new factual information in these submissions. The Department intends to set the same deadline on the record of the companion AD investigation. For further information regarding proposed scope excusions, see the Preliminary Decision Memorandum accompanying this notice.

The Department is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, the Department preliminarily determines that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.9

As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), the Department is aligning the final CVD determination in this investigation with the final determination in the companion AD investigation of softwood lumber from Canada based on a request made by the petitioner.10 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than September 6, 2017, unless postponed.

Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, the Department shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and de minimis rates and any rates based entirely under section 776 of the Act.

In this investigation, the Department calculated individually estimated countervailable subsidy rates for Canfor Corporation (Canfor), J.D. Irving, Limited (JDIL),11 Resolute FP Canada Inc. (Resolute), Tolko Marketing and Sales Ltd. (Tolko), and West Fraser Timber Co. Ltd. (West Fraser), that are not zero, de minimis, or based entirely on facts otherwise available. The Department calculated the all-others rate using a weighted-average of the individually estimated subsidy rates calculated for the examined respondents using each company's business proprietary data for the merchandise under consideration.12

The Department preliminarily determines that the following estimated countervailable subsidy rates exist:

In accordance with section 703(d)(1)(B) and (d)(2) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the rates indicated above.

Section 703(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. As discussed in Preliminary CC Determination, the Department preliminarily found that critical circumstances exist for imports of subject merchandise produced and/or exported by JDIL and the companies subject to the All-Others rate.18 Accordingly, in accordance with section 703(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of merchandise from the exporters/producers identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.

The Department intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement or within five days of the date of this notice in accordance with 19 CFR 351.224(b).

As provided in section 782(i)(1) of the Act, the Department intends to verify the information relied upon in making its final determination.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.19 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, at a time and date to be determined and interested parties will be notified by the Department, via letter. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

In accordance with section 703(f) of the Act, the Department will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.

This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

Background

On April 20, 2010, the mobile offshore drilling unit, Deepwater Horizon, which was being used to drill a well for BP Exploration and Production Inc. (BP), in the Macondo prospect (Mississippi Canyon 252—MC252), exploded, caught fire and subsequently sank in the Gulf of Mexico, resulting in an unprecedented volume of oil and other discharges from the rig and from the wellhead on the seabed. The Deepwater Horizon oil spill is the largest oil spill in U.S. history, discharging millions of barrels of oil over a period of 87 days. In addition, well over one million gallons of dispersants were applied to the waters of the spill area in an attempt to disperse the spilled oil. An undetermined amount of natural gas was also released to the environment as a result of the spill.

The Deepwater Horizon State and Federal natural resource trustees (DWH Trustees) conducted the natural resource damage assessment (NRDA) for the Deepwater Horizon oil spill under the Oil Pollution Act 1990 (OPA; 33 U.S.C. 2701 et seq.). Pursuant to OPA, Federal and State agencies act as trustees on behalf of the public to assess natural resource injuries and losses and to determine the actions required to compensate the public for those injuries and losses. OPA further instructs the designated trustees to develop and implement a plan for the restoration, rehabilitation, replacement, or acquisition of the equivalent of the injured natural resources under their trusteeship, including the loss of use and services from those resources from the time of injury until the time of restoration to baseline (the resource quality and conditions that would exist if the spill had not occurred) is complete.

Upon completion of the NRDA, the DWH Trustees reached and finalized a settlement of their natural resource damage claims with BP in a Consent Decree 1 approved by the United States District Court for the Eastern District of Louisiana. Pursuant to that Consent Decree, restoration projects in Louisiana are now chosen and managed by the Louisiana TIG. The Louisiana TIG is composed of the following Trustees:

• U.S. Department of the Interior, as represented by the National Park Service, U.S. Fish and Wildlife Service, and Bureau of Land Management;

• National Oceanic and Atmospheric Administration, on behalf of the U.S. Department of Commerce;

• U.S. Department of Agriculture;

• U.S. Environmental Protection Agency;

• Louisiana Coastal Protection and Restoration Authority;

• Louisiana Department of Natural Resources;

• Louisiana Department of Environmental Quality;

• Louisiana Oil Spill Coordinator's Office; and

• Louisiana Department of Wildlife and Fisheries.

These restoration planning activities are proceeding in accordance with the PDARP/PEIS. Information on the Restoration Type: Restore Wetlands, Coastal, and Nearshore Habitats, as well as the OPA criteria against which projects will be evaluated, can be found in the PDARP/PEIS (http://www.gulfspillrestoration.noaa.gov/restoration-planning/gulf-plan) and in the Overview of the PDARP/PEIS (http://www.gulfspillrestoration.noaa.gov/restoration-planning/gulf-plan).

The first action taken in this Notice is to inform the public that the Louisiana TIG Trustees intend to prepare a Strategic Restoration Plan for Barataria Basin pursuant to the PDARP/PEIS and OPA. The Trustees intend to consider the use of wetlands, coastal and nearshore habitat projects or suites of projects from the Draft 2017 CMP as the basis for that Strategic Restoration Plan. Those Draft 2017 CMP projects will be evaluated under applicable authorities in comparison to other feasible alternatives for restoring wetland, coastal and nearshore habitat and services injured by the Deepwater Horizon oil spill.

The PDARP/PEIS provides TIGs the option to prepare strategic restoration plans “to focus and sequence priorities within a Restoration Area” and to “consider resources at the ecosystem level, while implementing restoration at the local level.” (PDARP Section 7.3.1). In addition, the NRDA implementing regulations specifically allow trustees to consider the use of existing projects (15 CFR 990.56), such as those identified in the draft 2017 CMP. The Louisiana TIG is proposing that this Strategic Restoration Plan will focus on wetland, coastal, and nearshore habitat restoration type projects in the Barataria Basin restoration area because the PDARP/PEIS found that Barataria Basin experienced some of the heaviest and persistent oiling from the DWH spill and because the Basin supports very high primary and secondary production that contributes to the overall health of the northern Gulf of Mexico ecosystem.

The Louisiana TIG anticipates that the Strategic Restoration Plan for Barataria Basin will select for further funding and development most, if not all, of the remaining projects applicable under the “Wetlands, Coastal, and Nearshore Habitats” Restoration Type to be implemented in the Barataria Basin by the Louisiana TIG under the PDARP/PEIS. Developing such a strategic plan for much of Barataria Basin restoration for this Restoration Type will allow the Louisiana TIG to identify a suite of projects that, taken together, best achieve the “integrated ecosystem restoration” called for in Chapter 5 of the PDARP/PEIS. A decision in the strategic plan to fund further development of projects will not be a final decision by the Louisiana TIG to proceed with implementation of those projects. Information about the “Wetlands, Coastal, and Nearshore Habitats” Restoration Type as well as the OPA criteria against which projects will be evaluated can be found in the PDARP/PEIS.

The second action taken in this Notice is to inform the public of the Louisiana TIG Trustees' initiation of restoration planning, which will include the preparation of a restoration plan (the Phase 2 Plan) that evaluates the Mid-Barataria Sediment Diversion project as a means of restoring injured wetland, coastal and nearshore resources and services in Barataria Basin to restore for injuries resulting from the Deepwater Horizon oil spill. The Louisiana TIG began this restoration planning effort on March 28, 2017, by requesting project ideas from the public. At that time, the Louisiana TIG requested project ideas that could benefit wetlands, coastal, and nearshore habitats in the Barataria Basin, the estuary most heavily impacted by the DWH oil spill. That notice was published on the Louisiana TIG Web site: (http://www.gulfspillrestoration.noaa.gov/restoration-areas/louisiana).

The Mid-Barataria Sediment Diversion, a large-scale sediment diversion, is one of the projects proposed in the Draft 2017 CMP. While the Louisiana TIG Trustees have not yet decided to move forward with a restoration plan for a Mid-Barataria Sediment Diversion, the project currently is undergoing engineering and design and supplemental scoping for preparation of an EIS, led by the USACE based on permit applications submitted by the Louisiana Coastal Protection and Restoration Authority pursuant to the provisions of section 404 of the Clean Water Act, section 10 of the Rivers and Harbors Appropriation Act of 1899, and section 14 of the Rivers and Harbors Appropriation Act of 1899, as amended. To facilitate the potential consideration of this project under OPA, it is the intent of the state and Federal Louisiana TIG Trustees to assist the USACE in the preparation of the EIS for the Mid-Barataria Sediment Diversion. In addition, the Federal Louisiana TIG Trustees are cooperating agencies with the USACE for the preparation of that EIS. In a coordinated Federal Register notice, the USACE is issuing a supplemental Notice of Intent regarding the scope of the EIS for the project, including the potential for the EIS to inform a NRDA decision on restoration planning in which case the Louisiana TIG Trustees would adopt the EIS for such purposes. The Louisiana TIG is seeking to facilitate public involvement regarding the EIS, and encourages interested person and entities to submit comments in response to the USACE EIS process regarding the Mid-Barataria Sediment Diversion.

With regard to the Phase 1 Plan, the Louisiana TIG Trustees will proceed with consideration of whether a combination of projects in the Draft 2017 CMP provides a basis for a Strategic Restoration Plan for Barataria Basin.

With regard to the potential Phase 2 Plan, the Louisiana TIG Trustees will review all public input received as part of the USACE's scoping process for the preparation of an EIS for the proposed Mid-Barataria Sediment Diversion project as the Trustees work with the USACE to prepare an EIS that supports both the USACE regulatory decisions and OPA restoration planning decisions. The Louisiana TIG Trustees will additionally seek formal public involvement in the Phase 2 Draft Restoration Plan process in accordance with applicable federal regulations and consistent with the PDARP/PEIS.

The documents included in the Administrative Record can be viewed electronically at the following location: http://www.doi.gov/deepwaterhorizon/adminrecord.

The Trustees opened a publicly available Administrative Record for the NRDA for the Deepwater Horizon oil spill, including restoration planning activities, concurrently with publication of the 2011 Notice of Intent (NOI) to Begin Restoration Scoping and Prepare a Gulf Spill Restoration Planning PEIS (pursuant to 15 CFR 990.45). The Administrative Record includes the relevant administrative records since its date of inception. This Administrative Record is actively maintained and available for public review.

The authority of this action is the Oil Pollution Act of 1990 (33 U.S.C. 2701 et seq.) and the implementing NRDA regulations found at 15 CFR part 990 and NEPA (42 U.S.C. 4321 et seq.).

Deletion

On 3/24/2017 (82 FR 15047), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletion from the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the product listed below is no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing a small entity to furnish the product to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product deleted from the Procurement List.

Accordingly, the following product is deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.

The following products are proposed for addition to the Procurement List for production by the nonprofit agency listed:

The following products and service are proposed for deletion from the Procurement List:

Under the PRA, 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 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 before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of the proposed revision to the collections of information listed below. 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 number.

Titles: Registration Under the Commodity Exchange Act (OMB control number 3038-0023); Registration of Swap Dealers and Major Swap Participants (OMB control number 3038-0072). This is a request for extension and revision of these currently approved information collections.

Abstract: The Commission recently revised its Form 8-R, the application form that individuals must use to register with the Commission as an associated person, floor broker, or floor trader, or to be listed as a principal. The collections of information related to Form 8-R were previously approved by OMB in accordance with the PRA and assigned OMB control numbers 3038-0023 and 3038-0072. Additionally, the Commission no longer requires individuals and entities to use Commission Form 3-R to update their registration information, which now can be updated directly on Forms 7-R or 8-R. The Commission therefore is reassigning to Forms 7-R and 8-R the information collection burdens previously associated with Commission Form 3-R. The collection of information related to Form 3-R was previously approved by OMB in accordance with the PRA and assigned OMB control number 3038-0023.

The revised Form 8-R contains several changes that increase the existing information collection burden, currently 0.8 hours, associated with Form 8-R. The Commission estimates that the changes, which are discussed below, when considered together in aggregate add a total of 0.1 burden hours to the information collection burdens associated with Form 8-R.

First, in the “Fingerprint Card Information” section, revised Form 8-R adds two new questions. One new question addresses new requirements and exemptions thereto contained in Commission Regulation 3.21(e) applicable to non-U.S. persons. The other new question addresses the fingerprinting requirement exception for certain outside directors of registered firms. Second, in the section titled “Disciplinary Information—Regulatory Disclosures,” a new question was added to existing Question E. Among other things, Question E inquires whether the applicant (or an entity of which the applicant was a principal) violated, or aided and abetted the violation of, any investment-related statutes or regulations, a potential statutory basis for refusing or conditioning registration. The new question directs the applicant to disclose whether he or she has ever been found to have “failed to supervise another person's activities under any investment-related statute or regulation.” Third, in the section titled “Disciplinary Information—Financial Disclosures,” the Commission revised Question J. Prior to the revision, Question J asked whether the applicant has “currently failed to comply with any order to pay any futures-related civil monetary penalties, restitution amounts, disgorgement amounts, reparation amounts or arbitration awards.” As revised, Question J now inquires whether the applicant “failed to pay any arbitration awards involving CFTC-regulated products, CFTC civil monetary penalties, CFTC restitution amounts, CFTC disgorgement amounts, or CFTC reparation amounts.”

The revised Form 8-R also contains several changes that do not alter the information collection burdens associated with Form 8-R. First, the revised Form 8-R combines into a single form two separate, existing versions of the Form 8-R, the Form 8-R “Individual Application” and the Form 8-R “Floor Trader Order Enterer Individual Application,” both of which were previously approved by OMB. In the section titled “Sponsor Information and Registration Categories,” the revised Form 8-R adds “floor trader order enterer” as a new category of persons that can be associated with a sponsor. Also in connection with this change, the revised Form 8-R includes two newly defined terms: “entity floor trader” and “floor trader order enterer.” Second, in the section titled “Principal Information,” the prior version of Form 8-R contained a blank space in which an applicant entered a title. In the revised Form 8-R, the space is replaced with a list of available titles for applicants to choose from. Third, NFA is simplifying the process by which it requests supplemental information and documentation regarding the applicant's criminal, regulatory or financial disclosures. The prior version of Form 8-R requested that applicants provide a written explanation of the facts and circumstances regarding any such disclosures. Applicants were also separately requested to provide NFA with copies of pertinent documents associated with each disclosure. To consolidate and modernize this process, the revised Form 8-R allows applicants to complete a separate “Disclosure Matter Page” for each matter, instance or event requiring disclosure and to simultaneously upload all pertinent documents associated with each disclosure. The Disclosure Matter Page provides applicants with an efficient and effective method of supplying the supplemental information and documentation that NFA requests in the normal course whenever an applicant responds affirmatively to any of the questions regarding criminal, regulatory or financial disclosures.

Lastly, the revised Form 8-R contains numerous changes to the language, formatting and organization of Form 8-R, all of which—individually and collectively—do not alter the information collection burdens associated with Form 8-R. The only changes to Form 8-R that affect the information collection burdens associated with the form are those discussed above.

Commission Regulations 3.11 and 3.31 historically required entities and individuals to use Commission Form 3-R to update or correct certain types of information that originally was supplied on Commission Forms 7-R or 8-R, the registration forms for entities and individuals respectively. Regulations 3.11 and 3.31 were amended in 2012 to reflect a new practice whereby Forms 7-R and 8-R could be directly updated online, and the requirement to use Form 3-R for updates, or for any other purpose, was deleted from the Commission rules. At that time, however, the Commission did not reassign to Forms 7-R and 8-R the information collection burden associated with the Form 3-R. The Commission is doing so now.

The information collection burden associated with Form 3-R is 0.1 hours. In reassigning that burden to Forms 7-R and 8-R, the Commission believes that it is appropriate to adopt a conservative approach and assign an additional 0.1 hours each to the Form 7-R and 8-R. Accordingly, by virtue of cancelling Form 3-R, and reassigning to Forms 7-R and 8-R the information collection burdens associated with Form 3-R, the information collections burdens for Forms 7-R and 8-R each will increase by 0.1 hours. The reassignment of the information collection burden from Form 3-R to Forms 7-R and 8-R reallocates the information collection burdens within OMB control number 3038-0023, and does not increase or decrease the total information collection burden under that control number.

With respect to the information collections discussed above, the CFTC invites comments on:

• Whether the proposed revision to the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

• The accuracy of the Commission's estimate of the burden of the proposed revision to the collection of information, including the validity of the methodology and assumptions used;

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

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

Burden Statement: As explained above, the Commission believes that the revisions to Form 8-R increase the information collection burdens associated with that Form under OMB control numbers 3038-0023 and 3038-0072. Additionally, the Commission believes that reassigning to Forms 7-R and 8-R the information collection burdens formerly associated with Commission Form 3-R reallocates the information collection burdens within OMB control number 3038-0023, and therefore does not increase or decrease the total information collection burden under that control number.

The Commission estimates the burden of this collection of information under OMB control number 3038-0023 to be:

Respondents/Affected Entities: (1) Users of Form 7-R, specifically futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, floor trader firms, and leverage transaction merchants; and (2) users of Form 8-R, specifically (i) associated persons of futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, and leverage transaction merchants; floor brokers; (ii) principals of futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, floor trader firms, or leverage transaction merchants; (iii) floor brokers; (iv) floor traders; and (v) floor trader order enterers.

Estimated Number of Respondents: 78,109.

Estimated Total Annual Burden on Respondents: 7,210 hours.

Frequency of Collection: Periodically.

There are no capital costs or operating and maintenance costs associated with this collection.

The Commission estimates the burden of this collection of information under OMB control number 3038-0072 to be:

Respondents/Affected Entities: (1) Users of Form 7-R, specifically swap dealers and major swap participants; and (2) users of Form 8-R, specifically principals of swap dealers and of major swap participants.

Estimated Number of Respondents: 770.

Estimated Total Annual Burden on Respondents: 648 hours.

Frequency of Collection: Periodically.

There are no capital costs or operating and maintenance costs associated with this collection.

I. Background

Individuals acting in certain capacities in the markets regulated by the Commission must file a completed Form 8-R with NFA.1 These applicants include: Associated persons of futures commission merchants, retail foreign exchange dealers, introducing brokers, commodity trading advisors, commodity pool operators, and leverage transaction merchants; floor brokers; and floor traders.2 Additionally, any individual acting in the capacity as principal of a futures commission merchant, retail foreign exchange dealer, introducing broker, commodity trading advisor, commodity pool operator, swap dealer, major swap participant, floor trader or leverage transaction merchant also must file a completed Form 8-R.3 Lastly, individuals that enter orders for floor trader firms must file the Form 8-R as well.4 Individual applicants have been required to use Form 8-R since 1977.5

Form 8-R requests information about the applicant that can be used to assess the applicant's fitness to engage in business as a derivatives professional. Form 8-R is a Commission form maintained and used primarily by the NFA. NFA is currently the only registered futures association authorized by the Commission in accordance with Section 17 of the Commodity Exchange Act (“Act”).6 Pursuant to Section 17(o) of the Act,7 Regulation 3.2,8 and a series of orders, the Commission delegated to NFA certain registration functions including, among other things, the processing of all Form 8-R filings.9 Since the first delegation to NFA in 1984, NFA has developed substantial expertise in registration matters, including reviewing and processing completed Forms 8-R. In 2002, with the approval of the Commission, NFA transitioned from a paper-based registration system to an online registration system that utilizes, among other things, an electronic version of Form 8-R.10

I. Background

Section 1013(b)(1) of the Consumer Financial Protection Act, 12 U.S.C. 5493(b)(1), establishes the Office of Research (OR) and assigns to it the responsibility of researching, analyzing, and reporting on topics relating to the Bureau's mission, including developments in markets for consumer financial products and services, consumer awareness, and consumer behavior. The Academic Research Council is a consultative body comprised of scholars that help the Office of Research perform these responsibilities. Section 3 of the ARC Charter states: The Council will provide the Office of Research advice and feedback on research methodologies, framing research questions, data collection, and analytic strategies. Additionally, the Council will provide both backward- and forward-looking feedback on the Office of Research's research work and will offer input into its research strategic planning process and research agenda. Specifically, Section 8(d) of the ARC Charter states:

The Academic Research Council will discuss methodology and direction for consumer finance research at the Bureau.

Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

Individuals who wish to attend the Academic Research Council meeting must RSVP to CFPB_504 [email protected] by noon, May 8, 2017. Members of the public must RSVP by the due date and must include “ARC” in the subject line of the RSVP.

The Council's agenda will be made available to the public on May 1, 2017, via consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

A recording and transcript of this meeting will be available after the meeting on the CFPB's Web site consumerfinance.gov.

The Board's charter is being renewed pursuant to 10 U.S.C. 2113a and in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(a). The Board's charter and contact information for the Board's Designated Federal Officer (DFO) can be found at http://www.facadatabase.gov/.

The Board shall assist the Secretary of Defense in an advisory capacity in carrying out the Secretary's responsible to conduct the business of the Uniformed Services University of the Health Sciences (“the University”). The Board shall provide advice and recommendations on academic and administrative matters critical to the full accreditation and successful operation of the University.

Under the provisions of 10 U.S.C. 2113a(b), the Board shall be composed of 15 members. All members of the Board are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Pursuant to 10 U.S.C. 2113a(e), Board members (other than ex-officio members), while attending conferences or meetings or while otherwise performing their duties as members, shall be entitled to receive compensation at a rate to be fixed by the Secretary of Defense. All members are entitled to reimbursement for official Board-related travel and per diem.

The public or interested organizations may submit written statements to the Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board. All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration.

On April 5, 2017 (82 FR 16577), DoD published a notice of meeting in the Federal Register to announce that DoD is hosting an “Industry Information Day” to present a briefing, and receive and address industry feedback on the implementation of Defense Federal Acquisition Regulation Supplement (DFARS) Case 2013-D018, “Network Penetration Reporting and Contracting for Cloud Services.”

The period for organizations to submit questions prior to DoD hosting an “Industry Information Day” is extended from May 1, 2017 to June 2, 2017, to provide additional time for parties to request information on the implementation of DFARS Case 2013-D018, “Network Penetration Reporting and Contracting for Cloud Services.” Questions should be sent by email to [email protected] with the subject line of the email stating, “Industry Information Day.”

The complete text of the Record of Decision is available at http://www.GOAEIS.com. Single copies of the Record of Decision are available upon request by contacting: GOA Supplemental EIS/OEIS Project Manager, Naval Facilities Engineering Command Northwest, 1101 Tautog Circle, Suite 203, Silverdale, Washington 98315-1101.

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

Title of Collection: 2017-18 National Teacher and Principal Survey (NTPS 2017-18).

OMB Control Number: 1850-0598.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 101,383.

Total Estimated Number of Annual Burden Hours: 46,749.

Abstract: The National Teacher and Principal Survey (NTPS), conducted biennially by the National Center for Education Statistics (NCES), is a system of related questionnaires that provides descriptive data on the context of elementary and secondary education. Redesigned from the Schools and Staffing Survey (SASS) with a focus on flexibility, timeliness, and integration with other ED data, the NTPS system allows for school, principal, and teacher characteristics to be analyzed in relation to one another. NTPS is an in-depth, nationally representative survey of first through twelfth grade public school teachers, principals, and schools. Kindergarten teachers in schools with at least a first grade are also surveyed. NTPS utilizes core content and a series of rotating modules to allow timely collection of important education trends as well as trend analysis. Topics covered include characteristics of teachers, principals, schools, teacher training opportunities, retention, retirement, hiring, and shortages. Preliminary activities for NTPS 2017-18, namely: (a) Contacting and seeking research approvals from public school districts with an established research approval process (“special contact districts”), (b) notifying districts that their school(s) have been selected for NTPS 2017-18, and (c) notifying sampled schools of their selection for the survey and verifying their mailing addresses, were approved in November 2016 with revisions in March 2017 (OMB# 1850-0598 v.16-17). This request is to conduct NTPS 2017-18, including all of its recruitment and data collection activities. Because of the overlap in time, this request also carries over the burden and materials for the approved preliminary activities.

Purpose of Meeting: To provide advice and guidance to the Department of Energy and the National Science Foundation on scientific priorities within the field of high energy physics research.

Tentative Agenda: Agenda will include discussions of the following: June 5-6, 2017

• Discussion of Department of Energy High Energy Physics Program.

• Discussion of National Science Foundation Elementary Particle Physics Program.

• Reports on and Discussions of Topics of General Interest in High Energy Physics.

• Public Comment (10-minute rule).

Public Participation: The meeting is open to the public. A webcast of this meeting will be available. Please check the Web site below for updates and information on how to view the meeting. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of these items on the agenda, you should contact John Kogut, (301) 903-1298 or by email at: [email protected]. You must make your request for an oral statement at least five business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Panel will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

Minutes: The minutes of the meeting will be available on the U.S. Department of Energy's Office of High Energy Physics Advisory Panel Web site: http://science.energy.gov/hep/hepap/meetings/.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Public Participation: The EM SSAB, Northern New Mexico, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Menice Santistevan at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Menice Santistevan at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the Internet at: http://energy.gov/em/nnmcab/northern-new-mexico-citizens-advisory-board.

Purpose of the Board: The purpose of the Board is to provide advice and guidance on a continuing basis to the Department of Energy and the National Science Foundation on scientific priorities within the field of basic nuclear science research.

Tentative Agenda: Agenda will include discussions of the following:

Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of these items on the agenda, you should contact Brenda L. May, 301-903-0536 or [email protected] (email). You must make your request for an oral statement at least five business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

The minutes of the meeting will be available for review on the U.S. Department of Energy's Office of Nuclear Physics Web site at http://science.gov/np/nsac/meetings/.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Public Participation: The EM SSAB, Oak Ridge, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Melyssa P. Noe at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Melyssa P. Noe at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following Web site: https://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board/oak-ridge-site-specific-0.

The full text of these applications is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street SW., Washington, DC 20554 or electronically via the Media Bureau's Consolidated Data Base System, http://licensing.fcc.gov/prod/cdbs/pubacc/prod/cdbs_pa.htm.

On January 11, 2017, (82 FR 3315), the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on this renewal.

Proposal to renew the following currently approved collections of information:

1. Title: Interagency Biographical and Financial Report.

OMB Number: 3064-0006.

Form Number: Interagency Biographical and Financial Report.

Affected Public: Insured State Nonmember Banks and State Savings Associations.

Burden Estimate:

General Description of Collection: The Report is submitted to the FDIC by: (1) Each individual director, officer or individual or group of shareholders acting in concert that will own or control 10% or more of a proposed or operating depository institution applying for FDIC deposit insurance; (2) a person proposing to acquire control of an insured state nonmember bank or state savings association (FDIC-supervised institution); (3) each proposed new director or proposed new chief executive officer of an FDIC-supervised institution which has undergone a change in control within the preceding twelve months; and (4) each proposed new director or senior executive officer of an FDIC-supervised institution that is not in compliance with the applicable capital requirements or is otherwise in a troubled condition. The information is used by the FDIC to make an evaluation of the general character and financial condition of individuals who will be involved in the management or control of financial institutions, as required by statute. In order to lessen the burden on applicants, the FDIC cooperates with the other federal banking agencies to the maximum extent possible in processing the various applications. Notably, the Interagency Biographical and Financial Report will be amended to remove all references to the Office of Thrift Supervision as it appears on the form as well as changing the term “thrift” to “savings association.” These changes are technical and non-substantive in nature.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

2. Title: Prohibitions and Restrictions on Proprietary Trading and Certain Interests In and Relationships With, Hedge Funds and Private Equity Funds.

OMB Number: 3064-0184.

Form Number: None.

Affected Public: Insured state nonmember banks not under a holding company; state savings associations and state savings banks not under a holding company; subsidiaries of state nonmember banks, state savings associations, and state savings banks not under a holding company; and foreign banks having an insured branch and their branches and agencies.

General Description of Collection: Subject to certain exemptions, banking entities are generally prohibited from engaging in proprietary trading or from investing in, sponsoring, or having certain relationships with a hedge fund or private equity fund (“covered fund”). The Covered entities must retain certain records for a period that is no less than 5 years in a form that allows the prompt production of such records to the FDIC on request. The information collection requirements affecting FDIC-supervised institutions are summarized below.

Section 351.12(e) states that, upon application, a banking entity may obtain an extension of the period of time to meet the requirements on ownership limitations in this section for up to 2 additional years.

Section 351.3(d)(3) requires covered entities to have a detailed written liquidity management plan that specifically contemplates and authorizes certain otherwise prohibited securities to be used for liquidity management purposes.

Section 351.4(b)(3)(i)(A) provides that a trading desk or other organizational unit of another entity with more than $50 billion in trading assets and liabilities is not a client, customer, or counterparty unless the trading desk documents how and why a particular trading desk or other organizational unit of the entity should be treated as a client, customer, or counterparty of the trading desk for purposes of § 351.4(b).

Section 351.11(a)(2) requires that covered funds generally must be organized and offered only in connection with the provision of bona fide trust, fiduciary, investment advisory, or commodity trading advisory services and only to persons that are customers of such services of the banking entity, pursuant to a written plan or similar documentation outlining how the banking entity intends to provide advisory or other similar services to its customers through organizing and offering the covered fund.

Section 351.20(b) specifies the contents of a required compliance program for a banking entity with total consolidated assets of $10 billion or more including a provision requiring that records sufficient to demonstrate compliance with section 13 of the BHC Act and applicable regulations be maintained and retained for a period of no less than 5 years or such longer period as required by FDIC.

Section 351.20(e) specifies that any banking entity that has more than $10 billion in total consolidated assets as reported on December 31 of the previous two calendar years shall maintain records documenting the determination that each fund sponsored by the banking entity (including all subsidiaries and affiliates) is not a covered fund. Banking entities must also maintain a written plan documenting the treatment of certain seeding vehicles described in the regulation and, under certain circumstances, documentation of the value of the ownership interests owned by the banking entity in certain foreign public fund and each jurisdiction in which any such foreign public fund is organized.

Section 351.20(f)(1) applies to banking entities with no covered activities. A banking entity that does not engage in activities or investments pursuant to subpart B or subpart C (other than trading activities permitted pursuant to § 351.6(a) of subpart B) may satisfy the requirements of this section by establishing the required compliance program prior to becoming engaged in such activities or making such investments (other than trading activities permitted pursuant to § 351.6(a) of subpart B).

Section 351.20(f)(2) applies to banking entities with modest activities. A banking entity with total consolidated assets of $10 billion or less as reported on December 31 of the previous two calendar years may satisfy the requirements of this section by including in its existing compliance policies and procedures appropriate references to the statutory and regulatory requirements and adjustments as appropriate given the activities, size, scope and complexity of the banking entity.

Section 351.11(a)(8)(i) requires that a banking entity make certain clear and conspicuous written disclosures to any prospective and actual investor in a covered fund (such as through disclosure in the covered fund's offering documents).

There is no change in the method or substance of this information collection. The annual burden estimate has been reduced from 28,234 hours to 17,763 hours primarily because the FDIC estimates that all FDIC-supervised institutions have now completed the implementation phase of the information collection and are no longer subject to that burden. FDIC is using one (1) respondent as a place-holder for implementation burden. Another reason for the reduction in burden is that fewer institutions are subject to reporting, recordkeeping and disclosure requirements. The foregoing reductions in burden more than offset a modest increase in burden attributable to: (i) One additional institution growing in size to a degree that now makes it subject to 12 CFR 351.20(b) and (e) recordkeeping requirements; and (ii) an agency adjustment in its estimate of respondents affected by the recordkeeping requirements in 12 CFR 351.20(f)(1) due to the inadvertent omission of a class of respondents in its prior estimate.

Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Proposal to renew the following currently approved collections of information:

1. Title: Application for Waiver of Prohibition on Acceptance of Brokered Deposits.

OMB Number: 3064-0099.

Form Number: None.

Affected Public: Insured state nonmember banks and state savings associations.

Burden Estimate:

General Description of Collection: Section 29 of the Federal Deposit Insurance Act prohibits undercapitalized insured depository institutions from accepting, renewing, or rolling over any brokered deposits. Adequately capitalized institutions may do so with a waiver from the FDIC, while well-capitalized institutions may accept, renew, or roll over brokered deposits without restriction. This information collection captures the burden associated with preparing and filing an application for a waiver of the prohibition on the acceptance of brokered deposits.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

2. Title: Management Official Interlocks.

OMB Number: 3064-0118.

Form Number: None.

Affected Public: Insured state nonmember banks and state savings associations.

Burden Estimate:

General Description of Collection: The FDIC's Management Official Interlocks regulation, 12 CFR 348, which implements the Depository Institutions Management Interlocks Act (DIMIA), 12 U.S.C. 3201-3208, generally prohibits bank management officials from serving simultaneously with two unaffiliated depository institutions or their holding companies but allows the FDIC to grant exemptions in appropriate circumstances. Consistent with DIMIA, the FDIC's Management Official Interlocks regulation has an application requirement requiring information specified in the FDIC's procedural regulation. The rule also contains a notification requirement.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation as well as the change in complexity of the reporting institutions. In particular, the number of respondents has decreased while the hours per response have increased due to the complexity of the reporting institutions.

3. Title: Interagency Statement on Sound Practices Concerning Complex Structured Finance Transactions.

OMB Number: 3064-0148.

Form Number: Interagency Statement on Sound Practices Concerning Elevated Risk Complex Structured Finance Activities.

Affected Public: Insured state nonmember banks and state savings associations.

Burden Estimate:

General Description of Collection: The Interagency Statement on Sound Practices Concerning Complex Structured Finance Transactions describes the types of internal controls and risk management procedures that the Agencies believe are particularly effective in assisting financial institutions to identify, evaluate, assess, document, and control the full range of credit, market, operational, legal and reputational risks. A financial institution that engages in complex structured finance transactions should maintain a set of formal, written, firm-wide policies and procedures that are designed to allow the institution to identify and assess these risks.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

4. Title: Regulatory Capital Rules.

OMB Number: 3064-0153.

Form Number: None.

Affected Public: State nonmember banks, state savings associations, and certain subsidiaries of those entities.

Burden Estimate:

General Description of Collection: This collection comprises the disclosure and recordkeeping requirements associated with minimum capital requirements and overall capital adequacy standards for insured state nonmember banks, state savings associations, and certain subsidiaries of those entities. The data is used by the FDIC to evaluate capital before approving various applications by insured depository institutions, to evaluate capital as an essential component in determining safety and soundness, and to determine whether an institution is subject to prompt corrective action provisions.

There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response remain the same.

Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

A. Purpose

The Federal Funding Accountability and Transparency Act (P.L. 109-282, as amended by section 6202(a) of P.L. 110-252), known as FFATA or the Transparency Act requires information disclosure of entities receiving Federal financial assistance through Federal awards such as Federal contracts, sub-contracts, grants and sub-grants, FFATA 2(a), (2), (i), (ii). Beginning October 1, 2010, the currently approved Paperwork Reduction Act submission directed compliance with the Transparency Act to report prime and first-tier sub-award data. Specifically, Federal agencies and prime awardees of grants were to ensure disclosure of executive compensation of both prime and subawardees and sub-award data pursuant to the Transparency Act. This information collection requires reporting of only the information enumerated under the Transparency Act.

Sub-award Responses: 107,614.

Hours Per Response: 1.

Total Burden Hours: 107,614.

Executive Compensation Responses: 41,298.

Hours Per Response: 1.

Total Burden Hours: 41,298.

Total Annual Burden Hours: 148,912.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-0292, FFATA Subaward and Executive Compensation Reporting Requirements, in all correspondence.

A. Purpose

The Federal Funding Accountability and Transparency Act (P.L. 109-282, as amended by section 6202(a) of P.L. 110-252), known as FFATA or the Transparency Act, requires information disclosure of entities receiving Federal financial assistance through Federal awards such as Federal contracts, sub-contracts, grants and sub-grants, FFATA 2(a),(2),(i),(ii). The system that collects this information is called the FFATA Sub-award Reporting System (FSRS, www.fsrs.gov). This information collection requires information necessary for prime awardee registration in FSRS to create a user log-in and enable sub-award reporting for their entity. To register in FSRS for a user log-in, an entity is required to provide their Data Universal Numbering System (DUNS) number. FSRS then pulls core data about the entity from their System for Award Management (SAM) registration to include the legal business name, physical address, mailing address and Commercial and Government Entity (CAGE) code. The entity completes the FSRS registration by providing contact information within the entity for approval.

If a prime awardee has already registered in FSRS to report contracts-related Transparency Act financial data, a new log-in will not be required. In addition, if a prime awardee had a user account in the Electronic Subcontract Reporting System (eSRS), a new log-in will not be required.

Respondents: 5,678.

Responses Per Respondent: 1.

Total Annual Responses: 5,678.

Hours Per Response: .5.

Total Burden Hours: 2,839.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755.

Please cite OMB Control No. 3090-0291, FSRS Registration Requirements for Prime Grant Awardees, in all correspondence.

GSA is requesting the Office of Management and Budget (OMB) to review and approve information collection, 3090-0118, Statement of Witness, SF 94. This form is used by all Federal agencies to report accident information involving U.S. Government motor vehicles.

Respondents: 874.

Responses per Respondent: 1.

Total Annual Responses: 874.

Hours per Response: .333.

Total Burden Hours: 291.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-0118, Statement of Witness, SF 94, in all correspondence.

Proposed Revision of a Currently Approved Collection Project: “Developing a Registry of Registries.” OMB Control Number 0935-0203

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection on the development of a registry of patient registries. Patient registries have received significant attention and funding in recent years. Similar to controlled studies, patient registries represent some burden to patients (e.g., time to complete patient reported outcome measures, risk of loss of privacy), who often participate voluntarily in hopes of improving knowledge about a disease or condition. Patient registries also represent a substantial investment of health research resources. Despite these factors, patient registries are not required to be registered in ClinicalTrials.gov, presenting the potential for duplication of efforts and insufficient dissemination of findings that are not published in the peer-reviewed literature. To fulfill the obligation to patients and to ensure that resources are used in the most efficient manner, registries need to be listed in a manner similar to that of trials in ClinicalTrials.gov.

By providing a centralized point of collection for information about all patient registries in the United States, the Registry of Patient Registries (RoPR) enhances patient registry information, extracted from ClinicalTrials.gov, building on AHRQ's efforts to describe the quality, appropriateness, and effectiveness of health services (and patient registries in particular) in a more readily available, central location.

The RoPR database system aims to achieve the following objectives:

(1) Provide a searchable database of patient registries in the United States (to promote collaboration, reduce redundancy, and improve transparency);

(2) Facilitate the use of common data fields and definitions in similar health conditions (to improve opportunities for sharing, comparing, and linkage);

(3) Provide a public repository of searchable summary results (including results from registries that have not yet been published in the peer-reviewed literature);

(4) Offer a search tool to locate existing data that researchers can request for use in new studies; and

(5) Serve as a recruitment tool for researchers and patients interested in participating in patient registries.

To achieve the objectives of this project, the following data collections will be implemented:

(1) Collect information on registries from users who populate the RoPR database system.

AHRQ is proposing to add a self-registration option to the RoPR database so that registry owners do not need a National Library of Medicine Protocol Registration System (PRS) account to contribute. The current OMB-approved RoPR system requires users to have a PRS account. In the current data entry process, registry owners enter most of the registry information using the ClinicalTrials.gov PRS. If a user defines the ClinicalTrials.gov record as a patient registry, that user will have the option of following a link to the RoPR submission page to input additional information about the registry. Patient registry data entered in the PRS is uploaded to the RoPR system daily and is accessible (along with information entered directly into RoPR) to the public via the RoPR search function.

Under the AHRQ proposal, these users can complete a simple registration on the RoPR site, which would be less burdensome than the PRS registration process, and then enter all registry information directly on RoPR. The rationale behind this alternative registration pathway is that many registries are created for quality reporting, outcome tracking, and quality improvement purposes, rather than for research purposes. Registering in ClinicalTrials.gov implies a research purpose, so it is not necessarily appropriate for non-research registries to register in ClinicalTrials.gov, and many have expressed that they do not wish to do so. AHRQ anticipates that more than 75 percent of registries will still register through the ClinicalTrials.com. However, the remaining registries are extremely important for health policy, and providing them with a registration pathway furthers the goal of creating a central place where stakeholders can find information on research and non-research registries pertinent to a specific clinical topic.

The new self-registration pathway is being developed by AHRQ through its contractor, L&M Policy Research and subcontractor Truven Health Analytics, an IBM Company, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to database development. 42 U.S.C. 299a(a)(1) and (8).

AHRQ, in collaboration with the Centers for Medicare & Medicaid Services (CMS), is also proposing to add three fields to the self-registration pathway related to the CMS initiative to create a Centralized Repository for Public Health Agencies and Clinical Data Registry Reporting. The purpose of the repository is to assist eligible professionals, eligible hospitals, and critical access hospitals in finding entities that accept electronic public health data. By adding these fields to the existing RoPR database, AHRQ will further the goal of creating a central place where stakeholders can find all pertinent information on registries.

The purpose and the use of the RoPR is to provide a readily available public resource strictly for patient registries, following the model of ClinicalTrials.gov, allowing for the increased availability and efficacy of patient registries. The information being collected in the RoPR Record is visible to the public visiting the RoPR Web site, and is readily available for public use.

The RoPR is an ongoing data collection initiative.

Exhibit 1 shows the estimated annualized burden hours for the respondent's time to participate in the RoPR. In 2016, 65 respondents manually entered a new RoPR record. It is expected that more than 75% of patient registries are research-focused and will continue to use the original ClinicalTrials.gov pathway described above. Thus, it is estimated that once the self-registration pathway is available, approximately 65 respondents will enter RoPR records through the ClinicalTrials.gov link annually, and an additional 16 respondents (roughly 25% of 65), representing non-research registries, will enter RoPR records through the new self-registration pathway.

Each respondent need enter his or her new RoPR record only once. The RoPR system sends an automated reminder to any registry owner who has not updated his or her RoPR record in the past year. In 2016, 132 RoPR entries were updated and released. Using the same logic as above, it is estimated that an additional 33 entries (25% of 132) might be updated annually once the self-registration pathway is available.

In January 2017, Truven Health Analytics used a sample of existing ClinicalTrials.gov registry entries to estimate the time needed to enter all additional fields added through the self-registration process. The sample included records representing a range of depth and complexity. For example, one registry record contained only one primary outcome measure. Another record contained three more detailed outcome measures (one primary, one secondary, and one other.)

As a result of the knowledge gained during these processes, it is estimated that it will take users 10 minutes, on average, to manually enter the additional fields added through the self-registration process. Adding this time to the estimated burden of completing the original RoPR fields (45 minutes), it is estimated that it will take users 55 minutes to complete all fields through the self-registration pathway.

It is estimated that it will take users 5 minutes to review and update the fields added through the self-registration pathway. Adding this time to the estimated burden of reviewing and updating the original RoPR fields (15 minutes), it is estimated that it will take 20 minutes for a person to review and make updates to an existing RoPR record created through the self-registration pathway.

Exhibit 2 shows the estimated cost burden associated with the respondent's time to participate in the RoPR. The total cost burden to respondents is estimated at an average of $4,017.51 annually.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection.

All comments will become a matter of public record.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. Employer-sponsored health insurance is the source of coverage for 84.4 million current and former workers, plus many of their family members, and is a cornerstone of the U.S. health care system. The Medical Expenditure Panel Survey—Insurance Component (MEPS-IC) measures the extent, cost, and coverage of employer-sponsored health insurance on an annual basis. These statistics for private industry are produced at the National, State, and sub-State (metropolitan area) level. Statistics are also produced for State and Local governments.

This research has the following goals:

(1) Provide data for Federal policymakers evaluating the effects of National and State health care reforms.

(2) Provide descriptive data on the current employer-sponsored health insurance system and data for modeling the differential impacts of proposed health policy initiatives.

(3) Supply critical State and National estimates of health insurance spending for the National Health Accounts and Gross Domestic Product.

The MEPS-IC is conducted pursuant to AHRQ's statutory authority to conduct surveys to collect data on the cost, use and quality of health care, including types and costs of private insurance, 42 U.S.C. 299b-2(a), and to conduct research on health care, 42 U.S.C. 299a.

To achieve the goals of this project, following data collections will be implemented for both private sector and state and local government employers:

(1) Pre-screener Questionnaire—The purpose of the Pre-screener Questionnaire, which is collected via telephone, varies depending on the insurance status of the establishment contacted. Establishment is defined as a single, physical location in the private sector and a governmental unit in state and local governments. For establishments that do not offer health insurance to their employees, the Pre-screener Questionnaire is used to collect basic information, such as number of employees. For establishments that do offer health insurance, the Pre-screener Questionnaire collects contact name and address information for the person in the establishment best equipped to complete the full questionnaire.

(2) Establishment Questionnaire—The purpose of the mailed Establishment Questionnaire is to obtain general information from employers that provide health insurance to their employees, including total active enrollment in health insurance, other employee benefits, demographic characteristics of employees, and retiree health insurance.

(3) Plan Questionnaire—The purpose of the mailed Plan Questionnaire is to collect plan-specific information on each plan (up to four plans) offered by establishments. This questionnaire obtains information on total premiums, employer and employee contributions to the premium, and plan enrollment for each type of coverage offered—single, employee-plus-one, and family—within a plan. It also asks for information on deductibles, copays, and other plan characteristics.

The primary objective of the MEPS-IC is to collect information on employer-sponsored health insurance. Such information is needed in order to provide the tools for Federal, State, and academic researchers to evaluate current and proposed health policies and to support the production of important statistical measures for other Federal agencies.

Exhibit 1 shows the estimated annualized burden hours for the respondent's time to participate in the MEPS-IC. The Pre-screener Questionnaire will be completed by 30,041 respondents and takes about 51/2 minutes to complete. The Establishment Questionnaire will be completed by 25,914 respondents and takes about 23 minutes to complete. The Plan Questionnaire will be completed by 22,943 respondents and will require an average of 2.2 responses per respondent. Each Plan Questionnaire takes about 11 minutes to complete. The total annualized burden hours are estimated to be 21,636 hours.

Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to participate in this data collection. The annualized cost burden is estimated to be $691,703.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) reapprove generic pre-testing Clearance 0935-0124 for three years to facilitate AHRQ's efforts to (1) employ evaluation-type methods and techniques to improve AHRQ's current data collection and estimation procedures, (2) develop new collections and procedures, including toolkits, and (3) revise existing collections and procedures. AHRQ believes that developing, testing, and evaluating data collection and estimation procedures using survey methods and other techniques in anticipation of agency-sponsored studies can improve its information collection efforts, and the products it develops and allow AHRQ to be more responsive to fast-changing developments in the health care research field. AHRQ uses techniques to simplify data collection and estimation procedures, reduce respondent burden, and improve efficiencies to meet the needs of individuals and small business respondents who may have reduced budgets and staff.

This clearance request is limited to research on data collection, toolkit development, and estimation procedures and reports and does not extend to the collection of data for public release or policy formation. The current Clearance (0935-0124) was granted on November 12, 2014, and expires on November 30, 2017.

This generic clearance will allow AHRQ to draft and test toolkits, survey instruments and other data collection and estimation procedures more quickly and with greater lead time, thereby managing project time more efficiently and improving the quality of the data AHRQ collects. In some instances, the ability to test and evaluate toolkits, data collection and estimation procedures in anticipation of work or early in a project may result in the decision not to proceed with additional activities, which could save both public and private resources and eliminate respondent burden.

This generic clearance will facilitate AHRQ's response to a changing environment. Many of the tools AHRQ develops are made available to the private sector to assist in improving health care quality. The health and health care environment changes rapidly and requires a quick response from AHRQ to provide refined tools.

These preliminary research activities will not be used by AHRQ to regulate or sanction its customers. They will be entirely voluntary and the confidentiality of respondents and their responses will be preserved. Proposed information collections submitted under this generic clearance will be submitted for review by OMB with a response expected in 14 days.

The information collected through preliminary research activities under this generic clearance will be used by AHRQ to employ techniques to (1) improve AHRQ's current data collection and estimation procedures, (2) develop new collections and procedures, including toolkits, and (3) revise existing collections and procedures in anticipation or in response to changes in the health or health care field. The end result will be improvement in AHRQ's data collections and procedures and the quality of data collected, a reduction or minimization of respondent burden, increased agency efficiency, and improved responsiveness to the public.

Exhibit 1 shows the estimated burden hours, over the full 3 years of this clearance, for the respondents' time to participate in the research activities that may be conducted under this generic clearance. Mail surveys will be conducted with about 6,000 persons (2,000 per year for 3 years) and are estimated to average 20 minutes. Mail surveys may also be sent to respondents via email, and may include a telephone non-response follow-up. Telephone non-response follow-up for mailed surveys is not counted as a telephone survey in Exhibit 1. Not more than 600 persons, over 3 years, will participate in telephone surveys that will take about 40 minutes. Web-based surveys will be conducted with no more than 3,000 persons and will require no more than 10 minutes to complete. About 1,500 persons will participate in focus groups which may last up to two hours, while in-person interviews will be conducted with 600 persons and will take about 50 minutes. Automated data collection will be conducted for about 1,500 persons and could take up to 1 hour. Cognitive testing will be conducted with about 600 persons and is estimated to take 11/2 hours to complete. The total burden over 3 years is estimated to be 8,900 hours (about 2,967 hours per year).

Exhibit 2 shows the estimated cost burden over 3 years, based on the respondent's time to participate in these research activities. The total cost burden is estimated to be $338,734.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Award Approving Official: Anne Schuchat, MD, (RADM, USPHS) Acting Director, Centers for Disease Control and Prevention, and Acting Administrator, Agency for Toxic Substances and Disease Registry.

The Behavioral Risk Factor Surveillance System (BRFSS) is the nation's premier system of health-related telephone surveys that collect state data about U.S. residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services. Established in 1984 with 15 states, BRFSS now collects data in all 50 states as well as the District of Columbia and three U.S. territories. BRFSS completes more than 400,000 adult interviews each year, making it the largest continuously conducted health survey system in the world.

The collection of health data through traditional surveillance modes including telephone and in-person interviewing, however, is becoming increasingly challenging and costly with declines in participation and changes in personal communications. In addition, the self-reported nature of responses particularly in the areas of nutrition, physical activity, sedentary behaviors, and sleep has been a major limitation in these surveillance systems, since self-reported data are subject to under/over reporting and recall bias. Meanwhile, the advent of new technologies and data sources including wearable devices (such as: Smart watches, activity trackers, sleep monitors, etc.), mobile health applications on smartphones or tablets, and data from social media represents an opportunity to enhance the ability to monitor health-related information and potentially adjust for methodological limitations in traditional self-reported data.

The Healthy Behavior Data (HBD) Challenge will be conducted concurrently with a similar challenge proposed by the Public Health Agency of Canada. This will enable the two countries to learn from their respective challenges and leverage information. We expect increased efficiency with a dual challenge.

Submissions will be accepted starting April 28, 2017. The submission period for phase I will end on July 31, 2017. The Phase II (Prototype Implementation) submission period will begin September 4, 2017 and end December 31, 2017. The grand prize finalist is anticipated to be announced in February of 2018.

Information on the Behavioral Risk Factor Surveillance System can be found at www.cdc.gov/brfss.

The Healthy Behavior Data Challenge responds to the call for new ways to address the challenges and limitations of self-reported health surveillance information and tap into the potential of innovative data sources and alternative methodologies for public health surveillance.

The Healthy Behavior Data (HBD) Challenge will support the development and implementation of prototypes to use these novel methodologies and data sources (e.g., wearable devices, mobile applications, and/or social media) to enhance traditional healthy behaviors surveillance systems in the areas of nutrition, physical activity, sedentary behaviors, and/or sleep among the adult population aged 18 years and older in the U.S. and U.S. territories.

The Challenge will launch as an ideation/open submission period in which eligible participants (outlined in Eligibility Rules) may register and submit an entry onto the Challenge Web site (https://www.challenge.gov/challenge/the-healthy-behavior-data-challenge/). Information about the Challenge and a link to the Challenge Web site can also be found at Challenge.gov. The 13-week ideation period will be followed by a 16-week resubmission period held for those who were chosen by the judges as semifinalists to further refine their idea. The Challenge Web site serves as the destination and submission portal. Participants may find the Challenge rules, eligibility criteria, evaluation criteria, additional resources, and the Challenge timeline on the Challenge Web site or at Challenge.gov.

Entries not in compliance with the submission requirements outlined below will be ineligible for further review and prize award. During the open submission period, eligible participants may register and submit an entry onto the Challenge Web site, to include:

1. A completed HBD Challenge Submission Template describing the proposed project, project personnel and data sources.

2. A PowerPoint or other visual presentation of the proposed project including purpose, methods and anticipated outcomes of the proposed approach, which could be used to present the proposal to a judging panel.

3. A description of data that are anticipated to be captured by the proposed approach, comparability to the Behavioral Risk Factor Surveillance System (BRFSS), and, if applicable, descriptions of online app(s), web-based tools or communication devices used to recruit or track subjects' healthy behavior information.

4. Proposal of a viable data source(s) from a currently available or a feasible future source (such as a proposed app or online tool). HBD Challenge participants may propose the use of public and/or private data sources, as long as respondent agrees to participate and the respondent confidentiality and privacy are maintained.

5. A demonstration of how CDC would be able to access the data.

6. A detailed outline of the information that will be obtained.

7. A demonstration of how data will be extracted and collected: Present the format in which it will be stored.

8. A description of how the new data source(s) could be linked with other data sources, in a statistically robust manner that could result in useful public health insights, citing statistical approaches and evidence to support the proposal.

9. A focus on one or more behavioral factors including physical activity, sleep, sedentary behaviors, and/or nutrition.

10. Information about the population reached and generalizability of the approach.

11. A description of how data could be stratified by demographic characteristics (e.g. age, sex, education, geographic jurisdiction).

12. An indication of how information gathered addresses some or all of the following common metrics in one or more of the healthy behavior topics below:

a. Sleep:

b. Sedentary Behaviors:

c. Nutrition:

d. Physical activity:

Participants may also choose to suggest additional metrics in the areas of nutrition, physical activity, sedentary behaviors, and/or sleep. If additional metrics are included, the participant should include a short description of the data and how it might inform public health efforts (such information and data will be collected in accordance with any applicable laws and regulations).

During The Phase II Prototype Implementation Phase, the six submissions selected under Phase I will test their solutions, utilizing their previously collected data from 300 or more adults (aged 18 and above) residing in the U.S. or its territories. During this phase there will be an opportunity for HBD Challenge participants to incorporate data from existing surveys including the Behavioral Risk Factor Surveillance System (BRFSS).

Phase II (Prototype Implementation) allows applicants to test proposals developed in Phase I. The prototype is a demonstration of possible methods for supplementing data from existing surveillance systems (such as the BRFSS). This prototype is not meant to be merged with existing surveillance systems, but rather to complement data collected with current infrastructures. At the end of implementation HBD Challenge participants should be able to:

1. Compare data obtained by the prototype to data from the BRFSS in the areas of nutrition, physical activity, sedentary behaviors, and/or sleep.

2. Demonstrate how data from the included participants could be stratified by demographics (age, sex, education, etc.).

3. Demonstrate the ease of adding additional types of mobile applications and wearable devices to existing survey methodologies.

4. Report that describes the prototype/methodology and the prototype's anticipated strengths and limitations for surveillance.

5. Demonstrate the applicability of the non-traditional data source(s) for ongoing public health surveillance purposes.

6. Describe the prototype in detail, including purpose, method, outcomes and comparability to data obtained from the Behavioral Risk Factor Surveillance System (BRFSS).

7. Provide a working prototype including data (in Excel format) obtained using the prototype from 300 or more adult respondents residing in the U.S. or its territories. The data must include the age, gender, location, and at least one of the measures associated with the HBD Challenge in the areas of nutrition, physical activity, sedentary behaviors and/or sleep.

8. Provide a PowerPoint presentation to the judges and invited CDC personnel which includes information on the purpose, methods, outcomes and comparability to the BRFSS.

Submissions must be free of security threats and/or malware. Applicants/Contestants agree that CDC may conduct testing on the product/submission to determine whether malware or other security threats may be present. CDC may disqualify the product if, in CDC's judgment, the app may damage government or others' equipment or operating environment or if the app, in CDC's judgment, is inconsistent with CDC's public health mission, utilizes software or other technologies without appropriate licenses, or any other reason deemed necessary.

Participants may enter by visiting healthdatachallenge.gov and challenge.gov and following the instructions for submission. The U.S. and Canadian challenges are being run in parallel and U.S. entrants should submit to this contest via challenge.gov and Canadian citizens to the Canadian contest found at healthdatachallenge.gov.

To be eligible to win a prize under this challenge, an individual or entity—

(1) Shall have registered to participate in the competition under the rules promulgated by the Centers for Disease Control and Prevention;

(2) Shall have complied with all the requirements under this section;

(3) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and

(4) May not be a Federal entity or Federal employee acting within the scope of their employment.

(5) Shall not be an HHS employee working on their applications or submissions during assigned duty hours.

(6) Are an individual or team comprised of members each of who are 18 years of age or over.

(7) Are not on the Excluded Parties List System located at www.sam.gov.

Additionally:

(a) Federal grantees may not use Federal funds to develop challenge applications unless consistent with the purpose of their grant award. Federal contractors may not use Federal funds from a contract to develop challenge applications or to fund efforts in support of a challenge submission.

(b) Employees of CDC, and/or any other individual or entity associated with the development, evaluation, or administration of the Challenge as well as members of such persons' immediate families (spouses, children, siblings, parents), and persons living in the same household as such persons, whether or not related, are not eligible to participate in the Challenge.

(c) An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

(d) Applicants must agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a competition, whether the injury, death, damage, or loss arises through negligence or otherwise.

(e) A solution may be disqualified if it fails to function as expressed in the description provided by the user, or if it provides inaccurate or incomplete information.

(f) CDC reserves the right to disqualify participants from the Challenge for inappropriate, derogatory, defamatory, or threatening comments or communication through the Challenge Web site or on the Challenge.gov Web site.

(g) Submissions must be free of security threats and/or malware. Applicants/Contestants agree that CDC may conduct testing on the product/submission to determine whether malware or other security threats may be present. CDC may disqualify the product if, in CDC's judgment, the product may damage government or others' equipment or operating environment.

(h) Applicants must obtain liability insurance or demonstrate financial responsibility in the amount of $0 for claims by: (1) A third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered applicant's insurance policy and registered applicant's agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and (2) the Federal Government for damage or loss to Government property resulting from such an activity. Applicants who are a group must obtain insurance or demonstrate financial responsibility for all members of the group.

(i) By participating in the Challenge, each Applicant agrees to comply with and abide by these Official Rules, Terms & Conditions and the decisions of the Federal Agency sponsors and/or the individual judges, which shall be final and binding in all respects.

To register for this Challenge, participants can access https://www.challenge.gov/challenge/the-healthy-behavior-data-challenge/ anytime during the proposal submission period stated above to register.

In Phase I (Prototype Development), participants will compete for a $30,000 prize pot from which up to six teams or submissions will be selected to receive a $5000 prize each).

In phase II, up to 3 participants will compete for a $70,000 prize pot. The following prizes will be awarded:

Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.

A review panel composed of subject-matter experts will judge eligible HBD Challenge entries. A judging panel will make final winner selections based upon the criteria outlined below and in compliance with the HHS Competition Judging Guidelines.

All Criteria are scaled 1-5, with 1 being the lowest score on each dimension and 5 being the highest score on each dimension. Scores are weighted by the proportion of each dimension and then aggregated to create a final score.

1 = Prototype is likely to not work in a way that is statistically appropriate/5 = Prototype is likely to successfully collect, and harmonize data, in a statistically robust manner, across multiple data sources to address common metrics.

1 = Prototype does not consider stratification parameters, or applies to only a narrow population/5 = Prototype holds promise for capturing data that is valid, reliable, and representative of a large population.

1 = All parties expressed concerns with data being used in terms of respondent privacy, feasibility and utility/5 = All parties involved are comfortable with data being used in terms of respondent privacy, feasibility and utility. NOTE: This means that federal and state restrictions on data collection and assurance of confidentiality are being respected. Any proposals that appear to violate the Privacy Act, HIPAA, and FERPA will be unacceptable. (Mandatory criteria; if not scored 5, prototype may be disqualified).

1 = Prototype duplicates existing approach/5 = Prototype presents a novel approach.

1 = Prototype is not feasible due to factors like cost, availability of data, etc./5 = Prototype is feasible and addresses potential implementation challenges by offering solutions.

1 = Prototype is not generalizable to a range of data sources/5 = Prototype is generalizable to a range of data sources.

1 = Prototype does not address required metrics, across the identified content area(s)/5 = Prototype includes required metrics.

All Criteria are scaled 1-5, with 1 being the lowest score on each dimension and 5 being the highest score on each dimension. Scores are weighted by the proportion of each dimension and then aggregated to create a final score. Judging criteria for Phase II include:

1 = Prototype does not provide data that are likely to be valid or reliable or representative of a population/5 = Prototype provides data that demonstrate validity, reliability, and representativeness.

• Ability to complement BRFSS Findings (20%)

1 = Prototype does not outline steps to complement BRFSS efforts/5 = Prototype is provides data which can complement and/or supplement measures collected by the BRFSS or other publically available traditional surveillance systems.

• Validation of or Enhancement of existing national public health surveillance data (20%)

1 = Prototype cannot be statistically aligned with currently available health data/5 = Prototype statistically aligns with available data across population sub-groups.

1 = Prototype does not demonstrate the ability to include additional types of data and data sources/5 = Prototype demonstrates flexibility in the ability to add different data types and data from additional sources.

1 = Prototype's structure and operation is complex/5 = Prototype's structure is clear and easy to implement; it is not burdensome on current systems.

1 = Prototype requires heavy resource burden in terms of cost, training, administration, infrastructure/5 = Prototype has low resource burden in terms of cost, training, administration, infrastructure.

1 = there is a significant gap in time between data collection and analysis/5 = there is a real-time monitoring through the collected data.

1 = Prototype is unable to stratify the data by key demographics/5 = Prototype is able to stratify the data by age, sex, education, and race/ethnicity.

An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

Participants must also agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from my participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

Participants are required to obtain liability insurance or demonstrate financial responsibility in the amount of $0, for claims by a third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a challenge.

Participants must also agree to indemnify the Federal Government against third party claims for damages arising from or related to HBD Challenge activities.

CDC reserves the right to cancel, suspend, and/or modify the HBD Challenge, or any part of it, for any reason, at CDC's sole discretion.

Finalists and the Contest Winners must comply with all terms and conditions of these Official Rules, and winning is contingent upon fulfilling all requirements herein. The initial finalists will be notified by email, telephone, or mail after the date of the judging. Awards may be subject to Federal income taxes, and the Department of Health and Human Services will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.

• Applicants are free to discuss their submission and the ideas or technologies that it contains with other parties; encouraged to share ideas/technologies publicly; encouraged to collaborate or combine with other teams to strengthen their solutions; and are free to contract with any third parties. Applicants should be aware that any agreement signed or obligation undertaken in regards to their participation in this HBD Challenge that conflicts with the HBD Challenge rules, terms and conditions may result in disqualification of the Applicant's submission.

• Upon submission, each Applicant warrants that he or she is the sole author and owner of the work and any pertinent Intellectual Property (IP) rights, that the work is wholly original of the Applicant (or is an improved version of an existing work that the Applicant has sufficient rights to use—including the substantial improvement of existing open-source work), and that it does not infringe any copyright or any other rights of any third party of which Applicant is aware. Each Applicant also warrants that the work is free of security threats and/or malware.

• Applicants retain ownership of the data that they develop and deliver under the scope of the HBD Challenge, including any software, research product, or other intellectual property (“IP”) that they develop in connection therewith. Applicants agree to grant a license to the Federal Agency sponsor (CDC) for the use of the IP developed in connection with the HBD Challenge as set forth herein.

• Each Applicant must clearly delineate any Intellectual Property (IP) and/or confidential commercial information contained in a submission that is owned by the Applicant, and which the Applicant wishes to protect as proprietary data.

• Upon completion of the HDB Challenge period, applicants consent to grant CDC an unlimited, non-exclusive, royalty-free, worldwide license and the right to reproduce, publically perform, publically display, and use the Submission, including, without limitation, for promotional purposes relating to the HBD Challenge.

• All materials submitted to CDC as part of a submission become CDC agency records. Any confidential commercial or financial information contained in a submission must be clearly designated at the time of submission.

• If the Submission includes any third party works (such as third party content or open source code), Applicant must be able to provide, upon request, documentation of all appropriate licenses and releases for use of such third party works. If Applicant cannot provide documentation of all required licenses and releases, Federal Agency sponsors reserve the right, at their sole discretion, to disqualify the Submission. Conversely, they may seek to secure the licenses and releases and allow the applicable Submission to remain in the HBD Challenge, while reserving all applicable Federal agency rights with respect to such licenses and releases.

If Contestants choose to provide the CDC with personal information by registering or filling out the submission form through the Challenge.gov Web site, that information is used to respond to Contestants in matters regarding their submission, announcements of entrants, finalists, and winners of the Contest. Information is not collected for commercial marketing. Winners are permitted to cite that they won this contest.

The CDC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at CDC's sole discretion.

Participation in this Contest constitutes a contestants' full and unconditional agreement to abide by the Contest's Official Rules found at www.Challenge.gov.

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. Comments submitted in response to the 60-day FR Notice have been addressed in Appendix A of the ICR. 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: Extension of a currently approved collection; Title of Information Collection: Reconciliation of State Invoice and Prior Quarter Adjustment Statement; Use: Form CMS-304 (Reconciliation of State Invoice) is used by manufacturers to respond to the state's rebate invoice for current quarter utilization. Form CMS-304a (Prior Quarter Adjustment Statement) is required only in those instances where a change to the original rebate data submittal is necessary. Form Number: CMS-304 and -304a (OMB control number: 0938-0676); Frequency: Quarterly; Affected Public: Business or other for-profits; Number of Respondents: 1,037; Total Annual Responses: 4,148; Total Annual Hours: 187,880. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid Drug Rebate Program Forms; Use: We develop the rebate amount per drug unit from information supplied by the drug manufacturers and distributes these data to the states. States then must report quarterly to the drug manufacturers and report to us the total number of units of each dosage form/strength of their covered outpatient drugs reimbursed during a quarter and the rebate amount to be refunded. This report is due within 60 days of the end of each calendar quarter. The information in the report is based on claims paid by the state Medicaid agency during a calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required from states quarterly to report utilization for any drugs paid for during that quarter. Form CMS-368 (Administrative Data) is required only in those instances where a change to the original data submittal is necessary. Form Number: CMS-368 and -R-144 (OMB control number: 0938-0582); Frequency: Quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 224; Total Annual Hours: 12,101. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: State Children's Health Insurance Program and Supporting Regulations; Use: States must submit title XXI plans and amendments for approval by the Secretary. We use the plan and its subsequent amendments to determine if the state has met the requirements of title XXI. Information provided in the state plan, state plan amendments, and from the other information we are collecting will be used by advocacy groups, beneficiaries, applicants, other governmental agencies, providers groups, research organizations, health care corporations, health care consultants. States will use the information collected to assess state plan performance, health outcomes and an evaluation of the amount of substitution of private coverage that occurs as a result of the subsidies and the effect of the subsidies on access to coverage. Form Number: CMS-R-308 (OMB control number: 0938-0841); Frequency: Yearly, Once, and Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 28,294,596; Total Annual Hours: 1,473,885. (For policy questions regarding this collection contact Amy Lutzky at 410-786-0721).

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. Comments submitted in response to the 60-day Federal Register Notice have been addressed in Appendix A of the ICR. 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: Reinstatement with change of a previously approved collection; Title of Information Collection: Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death; Use: We provide coverage for implantable cardioverter-defibrillators (ICDs) for secondary prevention of sudden cardiac death based on extensive evidence showing that use of ICDs among patients with a certain set of physiologic conditions are effective. Accordingly, we consider coverage for ICDs reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. However, evidence for use of ICDs for primary prevention of sudden cardiac death is less compelling for certain patients.

To encourage responsible and appropriate use of ICDs, we issued a “Decision Memo for Implantable Defibrillators” on January 27, 2005, indicating that ICDs will be covered for primary prevention of sudden cardiac death if the beneficiary is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual § 310.1) or a qualifying prospective data collection system (either a practical clinical trial or prospective systematic data collection, which is sometimes referred to as a registry). Form Number: CMS-10151 (OMB control number: 0938-0967); Frequency: Occasionally; Affected Public: Business or other for-profits, Not-for-profit institutions; Number of Respondents: 1,600; Total Annual Responses: 80,000; Total Annual Hours: 20,000. (For policy questions regarding this collection contact JoAnna Baldwin at 410-786-7205.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy; Use: We provide coverage for carotid artery stenting (CAS) with embolic protection for patients at high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis between 50 percent and 70 percent or have asymptomatic carotid artery stenosis ≥80 percent in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual § 310.1, or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7). Accordingly, we consider coverage for CAS reasonable and necessary (section 1862(A)(1)(a) of the Social Security Act). However, evidence for use of CAS with embolic protection for patients with high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis ≥70 percent who are not enrolled in a study or trial is less compelling. To encourage responsible and appropriate use of CAS with embolic protection, we issued a Decision Memo for Carotid Artery Stenting on March 17, 2005, indicating that CAS with embolic protection for symptomatic carotid artery stenosis ≥70 percent will be covered only if performed in facilities that have been determined to be competent in performing the evaluation, procedure and follow-up necessary to ensure optimal patient outcomes. In accordance with this criteria, we consider coverage for CAS reasonable and necessary (section 1862(A)(1)(a) of the Social Security Act). Form Number: CMS-10199 (OMB control number: 0938-1011); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 1,370; Total Annual Responses: 4,110; Total Annual Hours: 28,998. (For policy questions regarding this collection contact Sarah Fulton at 410-786-2749.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Conditions of Coverage for Organ Procurement Organizations and Supporting Regulations; Use: Section 1138(b) of the Social Security Act, as added by section 9318 of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509), sets forth the statutory qualifications and requirements that organ procurement organizations (OPOs) must meet in order for the costs of their services in procuring organs for transplant centers to be reimbursable under the Medicare and Medicaid programs. An OPO must be certified and designated by the Secretary as an OPO and must meet performance-related standards prescribed by the Secretary. The corresponding regulations are found at 42 CFR part 486 (Conditions for Coverage of Specialized Services Furnished by Suppliers) under subpart G (Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations).

Since each OPO has a monopoly on organ procurement within its designated service area (DSA), we must hold OPOs to high standards. Collection of this information is necessary for us to assess the effectiveness of each OPO and determine whether it should continue to be certified as an OPO and designated for a particular donation service area by the Secretary or replaced by an OPO that can more effectively procure organs within that DSA. Form Number: CMS-R-13 (OMB control number: 0938-0688); Frequency: Occasionally; Affected Public: Not-for-profit institutions; Number of Respondents: 58; Total Annual Responses: 58; Total Annual Hours: 13,546. (For policy questions regarding this collection contact Diane Corning at 410-786-8486.)

4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Ambulatory Surgical Center Conditions for Coverage; Use: The Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs) focus on a patient-centered, outcome-oriented, and transparent processes that promote quality patient care. The CfCs are designed to ensure that each facility has properly trained staff to provide the appropriate type and level of care for that facility and provide a safe physical environment for patients. The CfCs are used by Federal or state surveyors as a basis for determining whether an ASC qualifies for approval or re-approval under Medicare. We, along with the healthcare industry, believe that the availability to the facility of the type of records and general content of records, which this regulation 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-10279 (OMB control number: 0938-1071); Frequency: Annual; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 5,500; Total Annual Responses: 5,500; Total Annual Hours: 209,000. (For policy questions regarding this collection contact Jacqueline Leach at 410-786-4282.)

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

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

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

FDA has become aware that the drug products listed in the table in this document are no longer being marketed.