Department of Health and Human Services 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Inspire Upper Airway Stimulation System (Inspire UAS 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.

The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register on October 13, 2017, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act ReviewAnnual Progress Report (APR) for Injury Control Research Centers (ICRC). The document provided the incorrect proposed project title, number of annual reporting responses for each respondent and average burden per response estimate.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled ``Draft Guidance on Methylphenidate Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride oral extended-release tablets.

This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

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 the opportunity to provide comment on a proposed and/ or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Respiratory Protective Devices information collection project.

The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), and for certain investigational new drugs (INDs). LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (March 15, 2021, for certain INDs).

The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder, entitled ``Draft Guidance on Salmeteral Xinafoate'' and ``Draft Guidance on Fluticasone Propionate.'' The guidances, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Application of the ``Solely Engaged'' Exemptions in Parts 117 and 507; Draft Guidance for Industry.'' The draft guidance, when finalized, will help establishments and facilities subject to certain FDA regulations determine whether they are ``solely engaged'' in certain activities. Establishments and facilities ``solely engaged'' in certain activities are exempt from some or all requirements of the regulations.

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 the American College of Physicians Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.

The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2018 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/ input, and challenges that impact the medical device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding the ELP.

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 or Agency) 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 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 information collection requirements for humanitarian use devices (HUDs).

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). This meeting will be open to the public but advance registration is required. Please register online at https://www.achdncmeetings.org/ by 12:00 p.m. Eastern Time on November 6, 2017. Information about the ACHDNC can be obtained by accessing the following Web site: https://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders/ .

The Food and Drug Administration is correcting a notice entitled ``Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications'' that appeared in the Federal Register of September 21, 2017 (82 FR 44185). The document announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The document was published with the incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Goals or Commitment Letter).

The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the enzyme packed cartridge's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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 Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2017.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Contact Investigation Outcome Reporting Forms, a collection that facilitates CDC working with state and local health departments in conducting contact investigations of individuals exposed to a communicable illness during travel.

The Centers for Disease Control and Prevention (CDC), 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 ``Online training for law enforcement to reduce risks associated with shift work and long work hours''. This study will develop and pilot test a new, online, interactive training program tailored for the law enforcement community that relays the health and safety risks associated with shift work, long work hours, and related workplace sleep issues and presents strategies for managers and officers to reduce these risks.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017 and certain proposed changes in policies and procedures surrounding its application.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Cook Medical Technologies, LLC, located in Bloomington, Indiana, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Forte Biosciences, Inc. located in San Diego, California.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

The United States has a long history of providing conscience protections in the regulation of health care for entities and individuals with objections based on religious beliefs and moral convictions. These interim final rules expand exemptions to protect religious beliefs for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration (HRSA), a component of the United States Department of Health and Human Services (HHS), to maintain the guidelines requiring contraceptive coverage where no regulatorily recognized objection exists. These rules also leave the ``accommodation'' process in place as an optional process for certain exempt entities that wish to use it voluntarily. These rules do not alter multiple other Federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy.

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 or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Format and Content of a REMS Document.'' A Risk Evaluation and Mitigation Strategy (REMS) document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS. This revised draft guidance describes a new recommended format for a REMS document. The new format was developed based on extensive stakeholder feedback. This guidance revises and supersedes the draft guidance entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' that was published by FDA on October 1, 2009.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``The Prohibition of Distributing Free Samples of Tobacco Products.'' The guidance provides information intended to assist tobacco product manufacturers, distributors, and retailers in complying with the regulations prohibiting the distribution of free samples of tobacco products.

The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to PaxVax, Inc., located in Redwood City, California, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.

In compliance with the Paperwork Reduction Act of 1995, 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.

Department of Health and Human Services, The Office of the Secretary (OS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.

The Indian Health Service published a notice in the Federal Register (FR) on August 14, 2017, for the Fiscal Year 2017 Preventing Alcohol-Related Deaths (PARD) through Social Detoxification program, Funding Announcement Number: HHS-2017-IHS-PARD-0001. Several Key Dates have been modified.

This final notice advises the public that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/Referred Care Delivery Area (PRCDA) for the Passamaquoddy Tribe's reservation at Indian Township (Passamaquoddy at Indian Township or Tribe) in the State of Maine.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Associate Program (PHAP) Alumni Assessment.

The Centers for Disease Control and Prevention (CDC), 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 the Paul Coverdell National Acute Stroke Program (2015-2020) Evaluation.

The Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session titled, ``Partnering to Prevent Hypoglycemia.'' The purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications. The Department of Health and Human Services invites public and private professionals, organizations, and consumer representatives to register to attend this listening session at https://health.gov/news/.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #236 entitled ``Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products.'' This guidance provides information regarding regulatory oversight of mosquito-related products, defined as those articles for use in or on mosquitoes. We are clarifying circumstances under which such products are regulated by the Food and Drug Administration (FDA) as new animal drugs under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

In compliance with the Paperwork Reduction Act of 1995, 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, the Agency, or we) is announcing a forthcoming public meeting entitled ``Animal Drug User Fee Act.'' The topic to be discussed is proposed recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA IV). The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Geneva.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECFIDERA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited in the room by 60 people and 75 lines over the phone. The public is also welcome to listen to the meeting by 1-888-790-2009, passcode: 7865774, with 75 lines. The deadline for notification of attendance is November 10, 2017. The public comment period is scheduled on Wednesday, November 15, 2017 from 2:00 p.m. until 2:15 p.m.; and from 3:25 p.m. until 3:40 p.m. EST, and on Thursday, November 16, 2017 from 10:10 a.m. until 10:25 a.m. EST. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by November 6, 2017 to William Cibulas at wic1@cdc.gov.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October meeting, the Advisory Council will welcome its new members and invite them to share their experiences and where they see the Council going over the length of their terms. The Advisory Council will also spend some time discussing the process of developing recommendations and how those recommendations relate to the National Plan. The Council will then spend much of the meeting discussing the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, held on October 16-17.

This document withdraws a proposed rule that was published in the Federal Register on January 12, 2017. The proposed rule specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom- fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, the proposed rule removed the current exemption from accreditation and quality standards for certain practitioners and suppliers.

This document withdraws a proposed rule that was published in the Federal Register on March 11, 2016. The proposed rule discussed our proposal to implement a new Medicare payment model under section 1115A of the Social Security Act (the Act).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Azza El-Remessy, Ph.D., University of Georgia, College of Pharmacy: Based on the report of an investigation conducted by the University of Georgia, College of Pharmacy (UGCP) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Azza El-Remessy, former Associate Professor, Department of Clinical and Administrative Pharmacy, UGCP, engaged in research misconduct in research supported by National Eye Institute (NEI), National Institutes of Health (NIH), grants R01 EY011766, R01 EY022408, and R01 EY04618, National Heart, Lung, and Blood Institute (NHLBI), NIH, grant R01 HL056259, and National Cancer Institute (NCI), NIH, grant K01 CA89689. ORI found that false Western blot data were included in: J Cell Sci. 118(Pt. 1):243-52, 2005 (hereafter referred to as ``J Cell Sci. 2005''). Retraction in: J Cell Sci. 129(16):3203, 2016. FASEB J. 21(10):2528-39, 2007 (hereafter referred to as ``FASEB J. 2007''). Retraction in: FASEB J. 31(1):421, 2017. PLoS One 8(8):e71868, 2013 (hereafter referred to as ``PLoS One 2013''). As a result of its investigation, UGCP recommended that PLoS One 2013 be corrected. As a result of the investigation, J Cell Sci. 2005 and FASEB J. 2007 have been retracted. ORI found that Respondent intentionally, knowingly, or recklessly used the same Western blot bands to represent different experimental results. Specifically, Respondent reused and relabeled bands in: 1. Figure 3B, J Cell Sci. 2005, to represent p38 bands from retinal cultured endothelial cells in high glucose in the absence of exogenous VEGF and also cells in peroxynitrite in the presence of exogenous VEGF. 2. Figure 4A, J Cell Sci. 2005, to represent nitrotyrosine immunoprecipitations from retinal endothelial cells cultured in normal glucose in the presence or absence of FeTTP; the Respondent also duplicated controls for p85 immunoprecipitation by using three bands representing 2 normal glucose and 1 high glucose treatments, flipping them horizontally (mirror images) to also represent 2 high glucose and 1 peroxynitrite treatments. 3. Figure 4B, J Cell Sci. 2005, to represent p85 immunoprecipitations from retinal endothelial cells stimulated with VEGF and also cells treated with either high glucose or peroxynitrite. 4. Figure 4A, PLoS One 2013, to represent immunoprecipitations for phosphorylated GSK-3 (p-GSK-3) in cells with normal glucose or high glucose for day 1 and to also represent cells treated with VEGF or VEGF+VEGFI (inhibitor); the Respondent also duplicated GSK-3 controls by using the same bands to represent high glucose treatment for day 1 and day 3 treatments, flipping them horizontally, to also represent for VEGF and VEGFRI treatments. 5. Figure 3, FASEB J. 2007, to represent phosphorylated VEGF2 (P- VEGF2) protein expression in microvascular endothelial cells in: Lanes 1 and 8, lanes 2 and 5, and lanes 6 and 7, where each lane represents different experimental conditions. Dr. El-Remessy entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter without further expenditure of time or other resources. Dr. El-Remessy accepts ORI's findings of research misconduct as set forth above but neither admits nor denies ORI's findings of research misconduct. The settlement is not an admission of liability on the part of the Respondent. Dr. El-Remessy voluntarily agreed, beginning on September 12, 2017: (1) To have her research supervised for a period of three (3) years beginning with the effective date of the Agreement; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of Respondent's duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for three (3) years beginning with the effective date of the Agreement, any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning with the effective date of the Agreement; and (4) that as a condition of the Agreement, Respondent will request that PLoS One 8(8):e71868, 2013 be corrected or retracted.

This document corrects technical and typographical errors in the final rule that appeared in the August 14, 2017, issue of the Federal Register, which will amend the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018.

The Food and Drug Administration (FDA or Agency) 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 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 the content and format requirements for pregnancy and lactation labeling for human prescription drugs and biological products.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Revision of a Currently Approved Information Collection (ICR-Rev). The revision would allow ACL to continue to collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as Amended (AT Act).

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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GIF) entitled ``M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance is intended to provide recommendations on the organization of the common technical document (CTD)/eCTD and replaces the August 2001 FDA guidance for industry ``M4: Organization of the CTD'' and the October 2005 FDA guidance for industry ``Granularity Document Annex to M4: Organization of the CTD.''

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.