Department of Health and Human Services April 4, 2014 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Opportunity To Co-sponsor an AHRQ Research Conference
AHRQ announces the opportunity for non-Federal public and private sector entities to co-sponsor an AHRQ conference in the Washington, DC area in early March, 2015. Potential co-sponsors must have a demonstrated interest and experience in health services research, implementation, and evaluation. Potential co-sponsors must also be capable of sponsoring and managing various discrete sessions or events associated with the conference and be willing to participate substantively in the co-sponsored activity.
Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act.'' The guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled ``Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.''
Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements.'' This final rule affirms the IFR's change to FDA's records access as required by the FDA Food Safety Modernization Act (FSMA). Prior to the passage of FSMA, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) provided the Secretary (by delegation FDA) with access to records relating to food that FDA reasonably believes to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
Guidance for Industry on What You Need To Know About Establishment, Maintenance, and Availability of Records-Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need To Know About Establishment, Maintenance, and Availability of Records Small Entity Compliance Guide'' (SECG), which updates an earlier guidance of the same title. Previously, this guidance restated the legal requirements of FDA's maintenance and establishment of records regulation and served as that regulation's SECG. Because the FDA Food Safety Modernization Act (FSMA) amended FDA's maintenance and establishment of records regulation, FDA issued an interim final rule (IFR) amending certain regulations to be consistent with the changes. Accordingly, FDA is revising this guidance to help any entity comply with FDA's maintenance and establishment of records requirements, including the amendments to these requirements made by the IFR as finalized. This guidance continues to serve as FDA's SECG.
Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review and other additional types of communication, to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed to in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III). These new Agency communication commitments are to increase the efficiency of the review process.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Request for Nominations: Advisory Committee on Training in Primary Care Medicine and Dentistry
The Health Resources and Services Administration (HRSA) is requesting nominations to fill eight vacancies on the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Notice of Supplemental Funding Opportunity
Funded in part by the Secretary's Minority AIDS Initiative Fund (SMAIF), as set forth in the Consolidated Appropriations Act of 2014, Public Law 113-76, H.R. 3547-376, a supplemental funding opportunity will be available in June 2014, for certain existing Health Center Program grantees funded under Section 330 of the Public Health Service (PHS) Act, as amended (42 U.S.C. 254b). This supplemental funding opportunity is one facet of a partnership between the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration, Bureau of Primary Health Care (HRSA, BPHC), which will encourage collaboration between Health Center Program grantees in geographic areas of high HIV/AIDS unmet need among racial/ ethnic minorities and state health departments to increase and improve HIV service delivery within their primary care programs. Under Secretary's Minority AIDS Initiative Funding to Increase HIV Prevention and Care Service Delivery among Health Centers Serving High HIV Prevalence Jurisdictions (CDC-RFA-PS14-1410), CDC will fund approximately four state health departments through a competitive application process among nine state health departments (Alabama, California, Florida, Maryland, Massachusetts, Michigan, New York, South Carolina, and Texas) that have been identified as eligible to apply for funding. State health department awardees must collaborate with Health Center Program grantees identified in their applications to increase and improve HIV service delivery among racial/ethnic minorities. Health Center Program grantees identified in awarded health department applications may subsequently apply for supplemental funding from HRSA for their participation in this collaboration. HRSA will award 12-24 supplemental awards ranging in amount from $250,000 to $500,000 to existing Health Center Program grantees identified by state health departments as collaborative partners in their applications for grant funding under Secretary's Minority AIDS Initiative Funding to Increase HIV Prevention and Care Service Delivery among Health Centers Serving High HIV Prevalence Jurisdictions (CDC- RFA-PS14-1410). This supplemental funding will support activities currently in scope of health center projects, including health center workforce development, infrastructure development, HIV service delivery across the HIV care continuum, and the development of sustainable partnerships with state health departments.
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