Department of Health and Human Services February 2016 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: NIOSH Criteria for a Recommended Standard: Occupational Exposure to Heat and Hot Environments [2016-106].

The Food and Drug Administration (FDA or we) is announcing the availability of the draft FDA Tribal Consultation Policy. We are also announcing the establishment of a docket to receive comments on the draft FDA Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy, when finalized, is to establish clear policies to further the government-to-government relationship between FDA and American Indian and Alaskan Native Tribes (hereafter, Indian Tribes) and facilitate tribal consultation with FDA. The draft FDA Tribal Consultation Policy provides background on FDA's mission and organizational structure and sets out principles and guidelines for the tribal consultation process.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic ActCompliance Policy.'' This guidance describes FDA's compliance policy regarding certain requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for trading partners engaged in transactions with first responders. This compliance policy is in effect until further notice by FDA.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``National Direct-to- Consumer Advertising Survey.'' The objective of this research is to survey the public about their experiences with and attitudes toward direct-to-consumer (DTC) advertising of prescription drugs.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on October 30, 2015 on pages 66913-4 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 18, 2015 (80 FR 72077), and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. For Further Information Contact: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Janet S. de Moor, Ph.D., MPH, Project Officer, Division of Cancer Control and Population Sciences, 9609 Medical Center Drive, 3E438, MSC 9764, Rockville, MD, 20850 or call non-toll-free number 240-276-6806 or Email your request, including your address to: janet.demoor@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: The National Physician Survey of Precision Medicine in Cancer Treatment 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this study is to investigate the current practice of precision medicine in cancer treatment among medical oncologists in the U.S. This is a nationally representative survey designed to assess oncologists' current and potential use of genomic testing, to inform the development of interventions to facilitate optimal use of genomic testing and to improve patient-physician discussions of the risks, possible benefits, and uncertainties surrounding the use of these tests. Current knowledge of this topic is limited as there are no nationally-representative studies on this topic to date. There are only two non-federal studies two that have examined physicians' knowledge and attitudes regarding somatic genetic and genomic testing. The survey will be administered by mail and web to medical oncology physicians across the U.S. Non- respondents will be invited to complete a follow-back survey to share their reasons for not participating. The study findings will inform NCI of relevant issues and concerns relating to the application of precision medicine to current and future cancer treatment patterns and practice. This information will also inform the development of new funding initiatives to optimize the use of precision medicine in cancer treatment. Additionally, information collected as part of this survey will be used to develop physician educational materials to address barriers to precision medicine in cancer care delivery. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 350.

The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 3, 2018.

This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0010. The ICR will expire on September 30, 2016. The 4040-0010 is composed of the following forms: Project Abstract; Project Performance Site Location(s); and Key Contacts. The ICR also requests categorizing these forms as common forms, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0001. The ICR will expire on June 30, 2016. The ICR also requests categorizing 4040-0001 as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 16, 2015, page 78243-78244 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), including the Intramural Research and Training Award (IRTA) and Superfund Research Program (SRP) within NIEHS, National Institute of General Medical Science (NIGMS), and National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.

On Wednesday, February 10, 2016 (81 FR 7124), the Centers of Medicare & Medicaid Services (CMS) published a Notice document titled ``Agency Information Collection Activities; Proposed Collection; Comment Request''. That notice invited public comments on four separate information collection requests. Through the publication of this correction document, we are notifying the public that we are no longer requesting or accepting public comments on the information collection request that published on Wednesday, February 10, 2016 (81 FR 7124), and is titled ``Medicare Prior Authorization of Home Health Services Demonstration.'' Form number: CMS-10599 (OMB control number: 0938New). All public comments regarding CMS-10599 should be submitted via the instructions listed in the original notice. The original notice for CMS-10599 published on Friday, February 5, 2016 (81 FR 6275). The original 60-day comment period for the notice that published on February 5, 2016 (81 FR 6275) remains in effect and ends on April 5, 2016.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are require; to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This notice, prepared by the Agency for Toxic Substances and Disease Registry (ATSDR) for the Department of Defense, announces the availability of two new draft toxicological profile on unregulated hazardous substances for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information or reports on studies about the health effects of Jet Fuels and 1- Bromopropane for review and potential inclusion in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our clients. Comments can include additional information or reports on studies about the health effects of Jet Fuels and 1-Bromopropane. Although ATSDR will consider key studies for these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Study to Explore Early Development (SEED) Phase 3.

In the Federal Register of November 18, 2015, the Food and Drug Administration (FDA) published a proposed rule entitled ``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' The proposed rule would establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. We are taking this action to reopen the comment period in response to requests to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of filing that appeared in the Federal Register of January 4, 2016. In the notice, FDA requested comments on a filed food additive petition (FAP 5A4810), submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled ``Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids.''

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for SUPERA PERIPHERAL STENT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Division of Loan Repayment (DLR), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at BoehlerS@od.nih.gov or by calling 301-451-4465. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Extension of a currently approved collection (OMB No. 0925-0361, expiration date 06/30/17). Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D., D.V.M, or equivalent doctoral degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research LRP) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by section 487F (42 U.S.C. 288-6); the Extramural Clinical Research LRP for Individuals from Disadvantaged Backgrounds (ECR-LRP) is authorized by an amendment to section 487E (42 U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP) is authorized by section 487B (42 U.S.C. 288-2); and the Health Disparities Research Loan Repayment Program (HD-LRP) is authorized by section 464z-5 (42 U.S.C. 285t-2). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH 2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10, NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH 2674-16, NIH 2674-17, NIH 2674-18, NIH 2674-19, and NIH 2674-20. The NIH Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program. The total estimated annualized burden hours are 33,242.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on submission of rotational plans for health warning label statements for smokeless tobacco products.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Immunogenicity- Related Considerations for Low Molecular Weight Heparin.'' This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and their potential impact on immunogenicity.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on (1) an extension of the study conducted with the original longitudinal youth cohort developed and surveyed for the outcome evaluation of FDA's General Market Youth Tobacco Prevention Campaign, (2) the development of a second longitudinal cohort for the purpose of continuing the evaluation, (3) an extension of the time period for the outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, (4) and an extension of the media tracking survey.

In accordance with the provisions of FACA, and after consultation with the General Services Administration (GSA), the Secretary of Health and Human Services (HHS) has determined that the reestablishment of the Technical Review Panel on the Medicare Trustees Reports is in the public interest. This Panel shall advise the HHS Secretary about the econometric and actuarial techniques and economic assumptions utilized in the Hospital Insurance (HI) and Supplementary Medical Insurance (SMI) Trust Fund reports, thus enhancing her ability to fulfill duties and responsibilities imposed by the PHSA (42 U.S.C. 201 et seq.)

The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Collections Related to Synthetic Turf Fields with Crumb Rubber Infill.'' The purpose of the proposed studies is to evaluate and characterize the chemical composition and use of synthetic turf with crumb rubber infill and exposure potential to constituents in crumb rubber infill.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device Panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the re-establishment of a CMP that CMS plans to conduct with the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS).

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the re-establishment of a CMP that CMS plans to conduct with the Internal Revenue Service (IRS), a Bureau of the Department of the Treasury.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this notice to advise the public that HHS/CDC has prepared and signed on February 9, 2016 a Finding of No Significant Impact (FONSI) based on the Final Environmental Assessment (Final EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The Final EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Verge Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).'' This public workshop will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The information gathered from the workshop and the public comments submitted to the docket will further inform FDA's development of its pilot project program.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on cyclosporine ophthalmic emulsion entitled ``Draft Guidance on Cyclosporine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclosporine ophthalmic emulsion. This draft guidance is a revised version of a previously issued draft guidance on the same subject.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Completeness Assessments for Type II API DMFs Under GDUFA''. It finalizes the draft guidance entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA'', which published on October 2, 2012. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).

The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled ``Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.'' The objective of the workshop is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The promise of using real- world evidence to promote the safety and effectiveness of medical devices can only be achieved through robust public-private partnerships and new approaches to informatics, epidemiology, biostatistics, and healthcare data systems integration.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled ``Inhalational Anthrax (Post- Exposure)Developing Antimicrobial Drugs'' issued in March 2002.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Manufactured Food Regulatory Program Standard.''

The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices''. The guidance identifies the types of UHMWPE currently in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration, in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE) is announcing a public conference entitled ``The FDA/PhUSE Annual Computational Science Symposium.'' The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them.

The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on March 11, 2016, on the programmatic implications of the United States Renal Data System (USRDS) to federal agencies. The meeting is open to the public.

Statement of organization, functions, and delegations of authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Early Childhood Development (ODAS-ECD) within the Office of the Assistant Secretary (OAS), the Office of Head Start (OHS), and the Office of Child Care (OCC). This reorganization will transfer reporting authority of OCC and OHS in their entirety from OAS to the ODAS-ECD. This reorganization creates within ODAS-ECD the Division of Policy and Budget; the Division of Comprehensive Services and Training and Technical Assistance; the Division of Research, Analysis, and Communications; and the Division of Interagency and Special Initiatives. Additionally, this reorganization will realign and combine several functions currently separately managed within OHS, OCC, and ODAS-ECD. The ODAS-ECD reviewed the programmatic and administrative similarities and differences between OHS and OCC and is proposing a new organizational structure that will not only retain the autonomy of the Head Start and Child Care programs and retain the best parts of how they provide services, but will also demonstrate a clear message to the field about the alignment of the Head Start and Child Care program offices, the unified focus of ensuring children receive quality services regardless of their program option, and a common message about the quality and expectations for services to children and families. Internally, the proposed reorganization will generate a more integrated alignment of standards through Head Start and Child Care programs, the development of a unified training and technical assistance system, consistent access to resources at the ACF level for both programs, and a shared use of research resources and agenda. Additionally, the proposed reorganization will result in greater collaborative efforts among both offices thereby leveraging best practices across both offices (monitoring, program outreach, content development, etc.). Moreover, both staffs will gain a broader understanding of the early childhood field and the inter-dependencies between programs. Within OHS, this reorganization eliminates the Education and Comprehensive Services Division and moves some of the functions to the newly created Division of Comprehensive Services and Training and Technical Assistance and the Division of Research, Analysis, and Communications within ODAS-ECD. It eliminates the Policy and Planning Division in OHS and moves some of those functions to the newly created Division of Policy and Budget within ODAS-ECD and to a new OHS Division of Planning, Oversight, and Policy. It eliminates the State Initiatives Division in OHS and moves some of those functions to each of the newly created Division of Interagency and Special Initiatives and the Division of Comprehensive Services and Training and Technical Assistance within ODAS-ECD. It also deletes the Grants and Contracts Division in OHS and moves the functions to two newly created and separate Divisions within OHSthe Division of Contracts and the Division of Grants. It combines the previous OHS Quality Assurance Division and OHS Policy and Planning Division to create the OHS Division of Planning, Oversight, and Policy. The OHS Program Operations Division remains the OHS Division of Program Operations. Within OCC, this reorganization eliminates the Division of Technical Assistance and moves most of its functions to the newly created Division of Comprehensive Services and Training and Technical Assistance within ODAS-ECD. It also eliminates the Division of Policy in OCC and moves some of those functions to the newly created Division of Policy and Budget within ODAS-ECD and to the new OCC Division of Planning, Data, and Policy. Within OCC, it creates a new Divisionthe Division of Oversight and Accountability. The OCC Division of Program Operations remains the Division of Program Operations. The goal of this reorganization is to more closely align early childhood programs, policies, and support functions in order to improve collaboration between OHS, OCC, and other federal agencies as appropriate. This will leverage best practices, generating more integrated and aligned standards through Head Start and Child Care, and improving access to ACF resources for OHS and OCC grantees while fully supporting the fundamental responsibility of operating Head Start and the Child Care and Development Fund to ensure the authorized purposes of each program and its funding are fully realized. This notice amends Part K of the Statement of Organization Functions, and Delegations of Authority of the Department of Health and Human Services, Administration for Children and Families: Chapter K, Administration for Children and Families, as last amended 77 FR 23250- 23260, April 18, 2012; Chapter KA, Office of the Assistant Secretary, as last amended 80 FR 33269-33270, June 11, 2015, and 75 FR 60471- 60473, September 30, 2010; Chapter KU, Office of Head Start (OHS), as last amended 75 FR 81280-81282, December 27, 2010; Chapter KV, Office of Child Care (OCC) as last amended 75 FR 60471-60473, September 30, 2010.