Department of Health and Human Services August 2012 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; Report of a New System of Records; FDA Records Related to Research Misconduct Proceedings
In accordance with the requirements of the Privacy Act of 1974 (the Privacy Act) and the Food and Drug Administration's (FDA's) regulations for the protection of privacy, FDA is publishing notice of a new Privacy Act system of records entitled ``FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC'' System No. 09-10-0020. Under the Department of Health and Human Services' (HHS' or the Department's) Public Health Service Policies on Research Misconduct, FDA has responsibilities for addressing research integrity and misconduct issues related to FDA supported activities. This system contains records related to the processing and reviewing of allegations of scientific research misconduct levied against an individual (the respondent) who is an agent of, or affiliated by contract or agreement with, FDA, or an FDA employee involved in intramural research. Research misconduct proceedings include allegation assessments, inquiries, investigations, oversight reviews by HHS' Office of Research Integrity (ORI), hearings, and administrative appeals.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, ``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.'' HHS is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. Elsewhere in this issue of the Federal Register, HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. HHS is publishing this companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency publishing this companion proposed rule under the agency's usual procedure for notice- and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws the direct final rule. The direct final rule and this companion proposed rule are substantively identical.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, ``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.'' HHS is exempting this system of records from certain provisions of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register, HHS is publishing a companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws this direct final rule. The companion proposed rule and this direct final rule are substantively identical.
Privacy Act of 1974; Proposed Exempt New System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act), the National Institutes of Health (NIH) is proposing to establish an exempt new system of records, 09-25-0223, ``NIH Records Related to Research Misconduct Proceedings, HHS/NIH.'' The new system will contain records pertaining to individual respondents who are the subject of research misconduct allegations or proceedings governed by the Public Health Service (PHS) Policies on Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 (``Part 93''). Because this is a law enforcement investigatory system, NIH has published a Notice of Proposed Rulemaking to exempt the system from certain requirements of the Privacy Act; specifically, the provisions pertaining to providing an accounting of disclosures, access and amendment, notification, and agency procedures and rules.
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for Reducing Cancer Among Women of Color Challenge
Disparities in prevention, early treatment, and final outcomes exist across the spectrum of cancer types and are often amplified in women's health when we look at breast cancer and gynecologic cancers primarily cervical, uterine, and ovarian cancer. With over 300,000 new cases combined and 68,000 deaths annually, the impact that these cancers have on the United States cannot be overstated. While the incidence and prevalence of these malignancies is as socially and geographically diverse as our nation, they strike minority and underserved women with a disproportionate lethality caused by many factors. In particular, the prevention strategies for these cancers cross the gambit of social and technical modalities from radiology (e.g., mammography) to advanced immunotherapy and vaccination (e.g., HPV vaccine). The clinical communities that treat and care for these patients is, likewise, among the broadest group of clinical disciplines that can be aggregatedfrom primary care and the surgical specialties to some of the most cutting-edge radiation oncology and medical oncology groups. But more importantly, any failure of our healthcare system to adequately prevent one of these cancers is most often a failure to address a myriad of social challenges, from education and access to health literacy and community support. The ``Reducing Cancer Among Women of Color Challenge'' is a call to developers to create a mobile device-optimized tool that engages and empowers women to improve the prevention and treatment of breast, cervical, uterine, and ovarian cancer in underserved and minority communities and interfaces with provider electronic health records (EHRs). The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Notice of Opportunity To Withdraw Abbreviated New Drug Applications To Avoid Backlog Fee Obligations
The Food and Drug Administration (FDA) is issuing this notice to provide applicants who are no longer seeking approval of their pending original abbreviated new drug applications (ANDAs) with an opportunity to withdraw them as soon as possible to avoid paying a fee. The fee in question is a one-time backlog fee that was established through enactment of the Generic Drug User Fee Amendments of 2012 (GDUFA). It will apply to any original ANDA that is pending (neither withdrawn nor tentatively approved) at FDA on October 1, 2012. This notice is intended to allow applicants to decide which ANDAs they do not wish to pursue and by timely notice of withdrawal avoid paying the new backlog fee on such applications.
Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) (Pub. L. 112-144, Title III) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry as it prepares to meet the self- identification requirement. It explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.
Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting to discuss implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug program enhancements and also requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The purpose of the public meeting is to discuss recent communications concerning GDUFA implementation and to provide an opportunity for the public to present views on these materials.
Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA also requires that generic drug facilities, sites, and organizations located around the world provide identification information annually to FDA. This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA.
Meetings of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a closed session under exemption 9(B) of the Government in Sunshine Act, 5 U.S.C. section 552b(c).
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice with comment period announces a hospital's request for a waiver from the requirement to have an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). In addition, this notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov or call 202-690-5566 and provide name, organization, and email address.
Center for Mental Health Services (CMHS); Revised as of August 21, 2012; Amendment of Meeting Notice
Medicare and Medicaid Programs; Continued Approval of Det Norske Veritas Healthcare's (DNVHC's) Hospital Accreditation Program
This final notice announces our decision to approve the Det Norske Veritas Healthcare (DNVHC) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. A hospital that participates in Medicaid must also meet the Medicare conditions of participation as referenced in 42 CFR 488.5(3)(b) and 42 CFR 488.6(b). This approval is effective September 26, 2012, through September 26, 2018.
Medicare Program; Approved Renewal of Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations
This notice announces our decision to renew the Medicare Advantage ``deeming authority'' of the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) for Health Maintenance Organizations and Preferred Provider Organizations for a term of 6 years.
Medicare Program; Solicitation of Two Nominations to the Advisory Panel on Hospital Outpatient Payment
This notice solicits nominations for two new members to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). There will be two vacancies on the Panel beginning September 30, 2012. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and supervision of hospital outpatient services. The Secretary rechartered the Panel in 2011 for a 2-year period effective through November 15, 2013.
Notice of Change in Notification of Refugee Social Services and Targeted Assistance Formula Grant Allocations
The Office of Refugee Resettlement, Administration for Children and Families (ACF), is changing the notification to States and Wilson/Fish Alternative Project grantees of final Social Services and Targeted Assistance formula grant awards. Under these two programs, formula grants are allotted to States based on the eligible population in each State. States and Wilson/Fish Alternative Project grantees use the grant awards to provide employment and other resettlement services to refugees, Amerasians, asylees, Cuban and Haitian entrants, victims of trafficking, and Iraqis and Afghans with Special Immigrant Visas. Sections 412(c)(1)(B) and 412(c)(2)(A) of the Immigration and Nationality Act do not require applications for the Social Services and Targeted Assistance formula grant programs. ORR has the discretion to alter the process by which States and Wilson/Fish Alternative Project grantees are notified of their annual allocations. Therefore, in an effort to streamline the process, an annual Funding Opportunity Announcement (FOA) will no longer be published. Instead, in addition to annual publication of a notice in the Federal Register, ORR will now also post tables of the allocations and the population figures used to calculate the award amount on the ORR Web site. In addition, official notification of awards will be provided to States and Wilson/Fish Alternative Project grantees by ACF's Division of Mandatory Grants.
Kelly Dean Shrum: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Kelly Dean Shrum, from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Shrum was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Shrum was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Shrum failed to respond. Dr. Shrum's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Comment Request; Communicating Composite Scores in Direct-to-Consumer Advertising
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising.'' This study is designed to explore how consumers understand and interpret composite endpoint scores in DTC ads.
Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations
This final rule makes technical changes that will update a requirement that many of the written agreements and memoranda of understanding (MOUs) between the Food and Drug Administration (FDA) and other departments, Agencies, and organizations be published in the Federal Register. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents.
Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals
The Food and Drug Administration (FDA) is amending its regulations regarding compounds of carcinogenic concern used in food- producing animals. Specifically, the Agency is clarifying the definition of ``So'' and revising the definition of ``Sm'' so that it conforms to the clarified definition of So. Other clarifying and conforming changes are also being made.
Cardiovascular and Renal Drugs Advisory Committee; Cancellation
The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for September 14, 2012, is cancelled. The meeting is no longer needed. This meeting was announced in the Federal Register of July 23, 2012 (77 FR 43093).
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