Department of Health and Human Services December 8, 2016 – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the ``SEARCH for Diabetes in Youth Study,'' a national multi-center study aimed at understanding more about diabetes among children and young adults in the United States.
A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Extension of Comment Period
On September 15, 2016 the Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register [81 FR 63482] announcing a public meeting and request for public comment on a draft testing protocol. Written comments were to be received by December 7, 2016. In response to a request from interested parties, NIOSH has extended the comment period until June 7, 2017. The longer timeframe will allow companies to acquire the proposed challenge agents and test their CSTDs with the proposed universal CSTD performance test protocol.
Scientific Information Request on Short and Long Term Outcomes After Bariatric Therapies in the Medicare Population
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions to inform our review of Short and Long Term Outcomes after Bariatric Therapies in the Medicare Population, which is currently being conducted by the AHRQ's Evidence- based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Privacy Act of 1974; Notice To Establish an Exempt System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the National Institutes of Health (NIH) proposes to establish a new system of records, to be numbered and titled: SORN 09- 25-0225 ``NIH Electronic Research Administration (eRA) Records, HHS/ NIH/OD/OER,'' which will be related to, but separate from, the system of records covered in SORN 09-25-0036 ``NIH Extramural Awards and Chartered Advisory Committee (IMPAC II), Contract Information (DCIS), and Cooperative Agreement Information, HHS/NIH.'' The new system of records will cover records used by NIH throughout the research and development award lifecycle, from application to scientific peer review, post-award monitoring, and close-out. Elsewhere in today's Federal Register, NIH has published a Notice of Proposed Rulemaking (NPRM) proposing to exempt confidential source- identifying material in the new system of records (i.e., material that would inappropriately reveal the identities of referees who provide letters of recommendation and peer reviewers who provide written evaluative input and recommendations to NIH about particular funding applications under an express promise by the government that their identities in association with the written work products they authored and provided to the government will be kept confidential) from certain requirements of the Privacy Act, specifically, from the provisions pertaining to providing an accounting of disclosures, access and amendment and notification. The exemptions and the promises of confidentiality are necessary to protect the integrity of NIH extramural peer review and award processes and ensure that NIH efforts to obtain accurate and objective assessments and evaluations of funding applications from referees and peer reviewers is not hindered. The exemptions will become effective when NIH publishes a Final Rule, which will not occur until the 60-day comment period provided in the NPRM has expired and any comments received on the NPRM (or on this System of Records Notice) have been addressed.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to exempt, from certain requirements of the Privacy Act, a subset of records in a new system of records, System No. 09-25-0225, NIH Electronic Research Administration (eRA) Records (NIH eRA Records), which covers records used in managing NIH research and development applications and awards throughout the award lifecycle. Elsewhere in today's Federal Register, HHS has published a proposed System of Records Notice (SORN) for System No. 09-25-0225 for public notice and comment. The subset of records proposed to be exempted is material that would inappropriately reveal the identities of referees who provide letters of recommendation and peer reviewers who provide written evaluative input and recommendations to NIH about particular funding applications under an express promise by the government that their identities in association with the written work products they authored and provided to the government will be kept confidential. Only material that would inappropriately reveal a particular referee or peer reviewer as the author of a specific work product (e.g., reference or recommendation letters, reviewer critiques, preliminary or final individual overall impact/priority scores, and/or assignment of peer reviewers to an application and other evaluative materials and data compiled by NIH/OER) is proposed to be exempted. The exemptions would protect not only an author's name in association with their written work product but any content that could enable the author to be identified from context. The Privacy Act provisions from which the material is proposed to be exempted are those that require the agency to provide an accounting of disclosures, access and amendment, and notification, which are contained in subsections (c)(3) and (d) of the Privacy Act.
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