Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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.

HHS gives notice of a determination concerning a petition to add a class of employees from the Weldon Spring Plant in Weldon Spring, Missouri, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. Sec. 7384q. On December 7, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

HHS gives notice of a decision to designate a class of employees from the Mound Plant in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Oak Ridge National Laboratory (X-10) in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a determination concerning a petition to add a class of employees from the Mound Plant in Miamisburg, Ohio, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On December 7, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Martin Biosse-Duplan, D.D.S., Ph.D., Harvard School of Dental Medicine: Based on the report of an investigation conducted by the Harvard School of Medicine (HSM) and Harvard School of Dental Medicine (HSDM), the admission of the Respondent, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Martin Biosse-Duplan, former Research Fellow, Department of Oral Medicine, Infection, and Immunity, HSDM, engaged in research misconduct in research supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), grant R01 AR054450. ORI found that the Respondent engaged in research misconduct involving one (1) laboratory presentation and two (2) published abstracts: Boisse-Duplan, M., Stephens, S., Lai, F.P.L., Oelkers, M., Kitamura, D., Rottner, K., Horne, W., & Baron, R. ``The Association Between the Microtubule Plus End Protein EB1 and Cortactin Controls Podosomes and Bone Resorption.'' J Bone Min Res 26:Supl.1, pS215. Boisse-Duplan, M., Stephens, S., Lai, F.P.L., Oelkers, M., Rottner, K., Horne, W., & Baron, R. ``In Osteoclasts, Dynamic Microtubules and their Associated Protein EB1 Control Podosomes and Bone Resorption through Cortactin.'' Bone 48:Suppl. 2, pS97. As a result of HSM's and HSDM's investigation, the data were not presented at the meetings and the experiments reported in the abstracts are being redone. Specifically, ORI finds that Respondent: Falsified Powerpoint slides and spreadsheets for histomorphometric and microCT results by using the values of HS1 knockout (KO) mice and their controls to represent the CathepsinK cre- Cortactin KO mice and their controls; Dr. Biosse-Duplan also switched two sets of numbers between the HS1 KO mice and their controls to falsely demonstrate a difference in bone density when there was none. The numerical data were presented at a lab meeting, and false text was included in two submitted meeting abstracts published in Bone 48:Suppl 2, pS97 and J Bone and Mineral Research 25:Suppl 1, pS215. Both the Respondent and HHS want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Dr. Boisse-Duplan has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) That if within two (2) years from the effective date of the Agreement Respondent does receive or apply for PHS support, Respondent agrees to have his research supervised for a period of two (2) years beginning on the date of his employment in a research position in which he receives or applies for PHS support and to notify his employer(s)/ institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for 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 agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) That if within two (2) years from the effective date of the Agreement, Respondent does receive or apply for PHS support, Respondent agrees that any institution employing him 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; and (3) To exclude himself 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 two (2) years, beginning on December 4, 2012.

The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). Our objective for the workshop is to provide a venue for an in- depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics for the treatment of CLL. Participants in the workshop will examine the advantages and disadvantages of MRD as a surrogate endpoint for approval, identify the preferred technology platform and performance characteristics for the assay of this biomarker, and discuss any issues regarding methodological standardization for the biomarker. The primary focus will be on the biomarkers that are ready for incorporation into clinical trials and the technical and regulatory challenges for use of these markers.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twelfth meeting in January. At this meeting, the Commission will continue discussing topics related to the ethical issues associated with the development of medical countermeasures for children.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Tuesday, November 20, 2012 (77 FR 69632). The document announced the availability of a draft guidance entitled ``Electronic Source Data in Clinical Investigations.'' The document was published with an incorrect date in the DATES section. This document corrects that error.

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 National Institute of Nursing Research (NINR), the 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 are invited on 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 obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. 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: Pediatric Palliative Care Campaign Pilot Survey-0925-New-National Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: NINR developed a Pediatric Palliative Care Campaign to address the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Pediatric Palliative Care Campaign Pilot Survey will assess the information and materials being disseminated as part of the Pediatric Palliative Care Campaign pilot. Survey findings will help (1) determine if the pilot campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand current perceptions, challenges, and information needs of health care providers when it comes to discussing pediatric palliative care so that information and materials can be refined; and (3) examine how effective the campaign pilot materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. This assessment will deliver strategic and actionable guidance for refining the campaign materials so that they can be used by a wider audience of health care providers. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 26.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's function, (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.

In this Notice of Proposed Rulemaking (NPRM), the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is proposing to update the definitions for interstate quarantine regulations to reflect modern terminology and plain language used by private industry and public health partners. These updates will not affect current practices. As part of the update, we are updating two existing definitions and adding eight new definitions to clarify existing provisions, as well as updating regulations to reflect the most recent Executive Order addressing quarantinable communicable diseases.

Through this Direct Final Rule, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is updating and reorganizing the Scope and Definitions for foreign quarantine regulations and add a new section to contain definitions for Importations. This Direct Final Rule (DFR) will update the scope and definitions to reflect modern terminology and plain language used globally by industry and public health partners. As part of the update, we are updating five existing definitions; adding thirteen new definitions to help clarify existing provisions; creating a new scope and definitions section for Importations under a new section by reorganizing existing definitions into this new section; and updating regulations to reflect the language used by the most recent Executive Order regarding quarantinable communicable diseases.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at 301-443-1984.

The Food and Drug Administration (FDA) is announcing the availability of two guidances for industry and investigators entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE StudiesSmall Entity Compliance Guide.'' These guidances are intended to help sponsors and investigators comply with the requirements in the final rule entitled ``Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,'' published in the Federal Register on September 29, 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses understand and comply with the regulations issued by FDA concerning safety reporting requirements for investigational new drug applications (IND) and bioavailability (BA) and bioequivalence (BE) studies.

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.

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) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatSummary Level Clinical Site Data for CDER's Inspection Planning.'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary level clinical site dataset). The summary level clinical site dataset is intended to facilitate use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. This draft guidance describes a recommended electronic format for the summary level clinical site dataset to be submitted voluntarily in new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications submitted to FDA's Center for Drug Evaluation and Research (CDER).

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). 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. Representatives of the three federal subgroups (Research, Clinical Care, Long-Term Services and Supports) will provide updates on the implementation of the National Plan to Address Alzheimer's Disease. The Advisory Council will hear a presentation on work underway by the Department of Veterans Affairs to support Veterans with Alzheimer's disease and their caregivers. The subcommittee chairs will present recommendations for adoption by the Advisory Council as formal recommendations to the Secretary of HHS and Congress.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Fifth Edition).'' The guidance provides updated information pertaining to registration of human and animal food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA) on January 4, 2011.

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces its intent to prepare an Environmental Impact Statement (EIS) for the proposed 2015-2025 Facilities Master Plan for HHS/CDC's Edward R. Roybal Campus located at 1600 Clifton Road NE., in Atlanta, Georgia. This announcement follows the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR Part 1500-1508); and, the Department of Health and Human Services (HHS) General Administration Manual Part 30 Environmental Procedures, dated February 25, 2000.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.'' The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials.

The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications.

The Food and Drug Administration (FDA or we) is establishing a docket to obtain comments relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens as defined in the Food Allergen Labeling and Consumer Protection Act of 2004.

This notice announces the availability of ten final toxicological profiles of priority hazardous substances prepared by ATSDR.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) invites comments and information on decompression tables used for protecting tunneling (caisson) workers from developing decompression illnesses. Public Comment Period: Comments must be received by March 29, 2013.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of investigational new drug applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application (e.g., monograph) with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The draft guidance includes recommendations intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Friday, December 7, 2012 (77 FR 73034). The product name in the document was incorrect. This document corrects that error.

In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, 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 July 13, 2012, page 41431 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 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. Proposed Collection: Title: The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research. Type of Information Collection Request: Reinstatement with Change; OMB Control Number: 0925-0602; Need and Use of Information Collection: This study will assess the value of the training programs administered by the Office of Clinical Research Training and Medical Education. The primary objective of the survey is to determine if training programs have had an impact on whether the trainees are performing clinical research, hold an academic appointment, have National Institutes of Health funding sources as well as to obtain information from the trainees as to what part of the National Institutes of Health medical education program they feel could be improved upon, the quality of the mentoring program, and how their National Institutes of Health training has contributed to their current clinical competence. Frequency of Response: On occasion. Affected Public: Individuals and businesses. Type of Respondents: Physicians and dentists, Ph.D. medical scientists, medical students, dental students, post-baccalaureate students, graduate students, post-doctoral students, and other health care professionals. The estimated annualized burden hours are as follows:

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) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on 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 vacancies effective with this notice.

This proposed rule provides further detail and parameters related to: the risk adjustment, reinsurance, and risk corridors programs; cost-sharing reductions; user fees for a Federally- facilitated Exchange; advance payments of the premium tax credit; a Federally-facilitated Small Business Health Option Program; and the medical loss ratio program. The cost-sharing reductions and advanced payments of the premium tax credit, combined with new insurance market reforms, will significantly increase the number of individuals with health insurance coverage, particularly in the individual market. The premium stabilization programsrisk adjustment, reinsurance, and risk corridorswill protect against adverse selection in the newly enrolled population. These programs, in combination with the medical loss ratio program and market reforms extending guaranteed availability (also known as guaranteed issue) protections and prohibiting the use of factors such as health status, medical history, gender, and industry of employment to set premium rates, will help to ensure that every American has access to high-quality, affordable health insurance.

According to the Agency for Healthcare Research and Quality (AHRQ), each year more than 2.5 million people in the United States are affected by skin breakdowns that cause pain, increased risk for serious infection, and increased health care utilization. The National Pressure Ulcer Advisory Panel (NPUAP) serves as the authoritative voice for improved patient outcomes in pressure ulcer prevention and treatment through public policy, education and research, and publishes resources and documents at www.npuap.org/. AHRQ has published an acute care toolkit for prevention of pressure ulcers at www.ahrq.gov/ research/ltc/pressureulcertoolkit/putool7b.htm. Many of today's electronic documentation systems require nurses to enter oversimplified text narratives or check boxes. Even when documentation systems include standard terminology, the data is locked inside proprietary software. Development of a mobile health application (app) for iPhone, iPad, or Android devices that implements standards for documenting and exchanging health information about pressure ulcers will facilitate meaningful information exchange and improve the patient experience and coordination of care across the healthcare continuum while reducing health care costs. A mobile health app would support nurses, in partnership with patients, families, caregivers and the multidisciplinary health care team, to reduce the incidence and severity of pressure ulcers. There are two goals for the Mobilizing Data for Pressure Ulcer Prevention Challenge. First, the development of a standard bedside pressure ulcer assessment tool, and second, the broader goal to promote the integration of nursing content into common information models and Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT). With documentation tools that include common information models and standard terminology for structured representation of appropriate nursing knowledge, nurses achieve the ability to track changes in patient status and to exchange information to improve continuity of care. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 11- 358).

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.

The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ``Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use; Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule addressing labeling and effectiveness testing requirements for over-the counter (OTC) sunscreen drug products. The guidance describes the requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Enforcement Fairness Act.

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) is announcing that a reinstatement 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 PRA).