Department of Health and Human Services January 2013 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification
Document Number: 2013-02093
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program
Document Number: 2013-02092
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Public Meeting
Document Number: 2013-02089
Type: Proposed Rule
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule), which are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis; Public Hearing
Document Number: 2013-02088
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Agency's regulation of drugs for the treatment and/or management of amyotrophic lateral sclerosis (ALS). FDA is holding this public hearing to allow patients, caregivers, advocates, health care providers, academia, industry, and other interested persons to give their perspectives on various aspects of the development of drugs for the treatment or management of ALS. The input from this public hearing will help inform the work of FDA offices that review applications for drugs for the treatment of ALS.
Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2013-02087
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that DIFFERIN (adapalene) solution, 0.1% (NDA 20-338), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for adapalene solution, 0.1%, if all other legal and regulatory requirements are met.
Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ
Document Number: 2013-02086
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for BEYAZ 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI
Document Number: 2013-02085
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for XALKORI 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction
Document Number: 2013-02084
Type: Notice
Date: 2013-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of January 7, 2013 (78 FR 951). The document announced a public workshop entitled ``Accessible Standardized Medical Device Labeling.'' The document was published with the incorrect date for submission of presentation materials. This document corrects that error.
Submission for OMB Review; Comment Request
Document Number: 2013-02079
Type: Notice
Date: 2013-01-31
Agency: Department of Health and Human Services, Administration for Children and Families
Patient Safety Organizations: Voluntary Relinquishment From The Connecticut Hospital Association Federal Patient Safety Organization
Document Number: 2013-01919
Type: Notice
Date: 2013-01-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides 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 and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, 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 no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from The Connecticut Hospital Association Federal Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.
Patient Safety Organizations: Voluntary Relinquishment From Ryder Trauma Center
Document Number: 2013-01909
Type: Notice
Date: 2013-01-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides 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 and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, 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 no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from Ryder Trauma Center of its status as a PSO, and has delisted the PSO accordingly.
Patient Safety Organizations: Voluntary Relinquishment From the BREF PSO
Document Number: 2013-01908
Type: Notice
Date: 2013-01-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides 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 and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, 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 no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the BREF PSO of its status as a PSO, and has delisted the PSO accordingly.
Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing; Correction
Document Number: 2013-02094
Type: Proposed Rule
Date: 2013-01-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document makes a technical correction to the proposed rule published in the January 22, 2013 Federal Register entitled ``Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing.'' The proposed rule provided for the close of the comment period to be February 13, 2013, whereas the close of the comment period was intended to be February 21, 2013. This document makes this technical correction.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-01989
Type: Notice
Date: 2013-01-30
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0220, which expires on July 31, 2013. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Healthcare Infection Control Practices Advisory Committee: Notice of Charter Renewal
Document Number: 2013-01980
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2013-01979
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-01978
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-01977
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-01976
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2013-01975
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Health Statistics: Notice of Charter Renewal
Document Number: 2013-01974
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-01945
Type: Notice
Date: 2013-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: 2013-01944
Type: Notice
Date: 2013-01-30
Agency: Food and Drug Administration, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-01881
Type: Notice
Date: 2013-01-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2013-01880
Type: Notice
Date: 2013-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-01849
Type: Notice
Date: 2013-01-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-01848
Type: Notice
Date: 2013-01-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Submission for OMB Review; Comment Request: National Institutes of Health Information Collection Forms To Support Genomic Data Sharing for Research Purposes
Document Number: 2013-01851
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 5, 2012 (77 FR 61008), 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. NIH 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: National Institutes of Health Information Collection Forms to Support Genomic Data Sharing for Research Purposes; Type of Information Collection Request: New; Need and Use of Information Collection: The NIH mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The sharing of research data supports this mission and is essential to facilitate the translation of research results into knowledge, products, practices, and procedures that improve human health. By enabling secondary research questions to be addressed, data sharing maximizes the public benefit achieved through research investments. NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) was established to enable the full value of GWAS data to be realized. GWAS data are maintained in a central data repository, the database of Genotypes and Phenotypes (dbGaP), which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH. As stipulated in the NIH GWAS Policy, all principal investigators (PIs) who receive NIH funding to conduct genomic research are expected to register studies with genomic data in dbGaP. The nature of the genomic, phenotypic, and other associated data generated through large- scale human genomic studies requires responsible stewardship throughout research and data sharing activities. Since the data being collected and shared are from human research participants, the protection of participant interests is paramount. PIs submitting data to dbGaP must describe any limitations on sharing the data, as defined in the informed consent provided by the participants from whom the data were originally collected. PIs must also provide basic study information such as the type of data that will be submitted to dbGaP and a description of the study. Researchers interested in using dbGaP data for secondary research must submit a request through dbGaP and be granted permission from the relevant NIH Data Access Committees to access the data. As part of the request process, researchers must provide information such as a description of the proposed research use of the dbGaP datasets, a data security plan, and a Data Use Certification, in which the researcher agrees to the terms and conditions for use of the data. NIH has developed online forms, which will be available through dbGaP, in an effort to reduce the burden for researchers to complete the study registration, data submission, and data access processes. Frequency of Response: As necessary. Description of Respondents: PIs and senior officials from their institutions. Estimate of Burden: The burden associated with this information collection is calculated in two parts: (1) the burden associated with registering genomic studies and submitting data to dbGaP and (2) the burden associated with applying for genomic data in dbGaP. The annual reporting burden for study registration and data submission is as follows: Estimated Number of Respondents: 100; Estimated Number of Responses per Respondent: 1; and Estimated Total Annual Burden Hours Requested: 63. The annual cost to respondents is estimated at $2,506. The annual reporting burden for applying for genomic data in dbGaP is as follows: Estimated Number of Respondents: 1, 266; Estimated Number of Responses per Respondent: 2; and Estimated Total Annual Burden Hours Requested: 1,583. The annual cost to respondents is estimated at $63,452. There are no capital, operating, or maintenance costs to the respondents.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-01815
Type: Notice
Date: 2013-01-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Foods has modified its structure and reorganized to the Office of Foods and Veterinary Medicine (OFVM). This new organizational structure was approved by the Secretary of Health and Human Services on July 20, 2012, and implemented on October 1, 2012.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-01789
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
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. 207 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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-01788
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2013-01787
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-01786
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-01785
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2013-01784
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-01783
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-01782
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-01781
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-01780
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2013-01779
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting.
Document Number: 2013-01778
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-01777
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-01776
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-01775
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-01770
Type: Notice
Date: 2013-01-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Request for Information (RFI): Opportunities To Apply a Department of Health and Human Services Message Library To Advance Understanding About Toddler and Preschool Nutrition and Physical Activity
Document Number: 2013-01728
Type: Notice
Date: 2013-01-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
This Request for Information (RFI) solicits ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply a library of short, evidence-based messages known as TXT4Tots. This library of brief informational nutrition and physical activity focused messages was developed and tested by the American Academy of Pediatrics (AAP) under a cooperative agreement with the Health Resources and Services Administration (HRSA). The TXT4Tots library is targeted to parents and caregivers of children, ages 1-5 years, and is available in both English and Spanish. Content for the messages was derived from AAP's ``Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents,'' which uses a developmentally based approach to address children's health needs in the context of family and community. The name TXT4Tots describes the library of developed messages and does not necessarily imply the need for dissemination through mobile, Short Message Service messaging. HRSA is issuing this RFI to solicit information and ideas on how to effectively incorporate the TXT4Tots library of messages into a wide variety of existing public and private programs and products that can best meet the needs of parents, caregivers, and child advocates, including health care providers. We recognize there are multiple ways this can occur and, therefore, are seeking input on how the TXT4Tots message library could be maximized to advance understanding about toddler and preschool nutrition and physical activity, and the interests of potential partners in working with HHS to do so. The intent is to build upon current programs, policies, and infrastructure to enhance education, disseminate the TXT4Tots message library, and leverage existing programs in innovative ways, particularly to support outreach to underserved communities where access to health education may be limited. The goal is to ensure that the TXT4Tots library of messages remains publicly available at no cost for noncommercial purposes. In addition to this RFI for written comments, HRSA intends to host a short, in-person forum in Washington, DC, to hear proposed comments from the public. Participation in the forum will also be possible through a dedicated conference call line and webinar capabilities. Further details on the forum are described below.
Smokeless Tobacco Product Warning Statements; Request for Comments and Scientific Evidence
Document Number: 2013-01626
Type: Proposed Rule
Date: 2013-01-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-01663
Type: Notice
Date: 2013-01-28
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services