Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Consumer Healthcare Product Association (CHPA) are announcing a public workshop entitled ``Adolescent Over-the-Counter (OTC) Drug Product Use.'' The purpose of the workshop is to gain an understanding of current use of OTC drug products by adolescents, including adolescent decisionmaking skills (compared with adult skills) and other factors influencing adolescent OTC drug product use. Information gathered at the workshop and from submitted comments will be used to identify when it would be most appropriate for consumer studies on OTC drugs to enroll adolescents, and to define the type of consumer research and study designs needed to support OTC drug product approval in the adolescent population. The workshop is intended to help inform FDA in its effort to assure the safe and effective use of OTC drug products by adolescents.

HRSA will be enhancing the partnership with the Home Safety Council (HSC) to collaborate on reaching America's low literacy population. Through this project, additional poison prevention training materials targeting the low literacy population will be developed and distributed to the public, poison centers, safety and injury prevention professionals, health educators, and first responders. HRSA first announced the partnership with the HSC in the Federal Register, Vol. 71, No. 146, July 31, 2006.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on what new reference values the agency should use to calculate the percent daily value (DV) in the Nutrition Facts and Supplement Facts labels and what factors the agency should consider in establishing such new reference values. In addition, FDA requests comments on whether it should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels. Comments on what factors should be considered to update the agency's reference values will inform any FDA rulemaking that may result from this ANPRM.

HRSA announces a revision to the program guidance for the Training in Primary Care Medicine and Dentistry Program posted on August 23, 2007 on Grants.gov, https://www.grants.gov. The guidance includes information for the following competitive funding opportunities: HRSA-08-032 Academic Administrative Units; HRSA-08-035 Physician Faculty Development; HRSA-08-037 Predoctoral Training; HRSA-08-039 Physician Assistant Training; HRSA-08-042 Residency Training; and HRSA- 08-044 Residency Training in General and Pediatric Dentistry. This revision only affects the Physician Faculty Development program, HRSA- 08-035. A revised guidance has been posted on Grants.gov. Specifically, the additional language included in the guidance is presented below: Primary Care Clinician Research FellowshipThis track provides fellowships that focus on development of primary care research investigators. DurationFellowships will last 2 to 3 years. FeaturesApplications should include a rigorous research/training track which is offered at an academic health science center. Advanced degrees (e.g., M.P.H., M.P.A.) are a desirable option. Desirable candidates include multidisciplinary physician faculty and fellows. Research areas should be consistent with the scope and content of primary care practice and education, and may include such areas as the linkage between Healthy People 2010 and health disparities, community and practice-based research, patient safety, quality improvement, professionalism, health literacy, and cultural competency. Stipend LevelEnhanced stipend level is equivalent to National Research Service Award (NRSA) stipends, which range from $36,996 for individuals entering immediately following receipt of their doctoral degree to $51,036 for individuals with 7 years or more of relevant experience and/or training. A table of stipend levels is provided in this guidance. Supplementation of the stipends is allowable and encouraged; however, the combination of stipend and supplementation may not exceed the full-time salary of comparable multidisciplinary physician faculty at the applicant's institution. Time RequirementPro-rated stipends are not available. For applicants requesting full stipends, 60 percent of a Fellow's time for 24- to 36 months of fellowship must be devoted to formal research training. The remaining 40 percent of time for a 24 to 36-month fellowship must be spent in activities consistent with the roles of academic faculty (clinical practice, teaching, and/or administration).

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Cancer Institute (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collected below. This proposed information collection was previously published in the Federal Register on August 13, 2007, Vol. 72, No. 55, Page 45251 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 December 1, 2007, unless it displays a valid OMB control number. Proposed Collection: Title: Drug Accountability Record (NCI) (Form NIH 2564). Type of Information Collection Request: Extension, with no changes OMB No. 0925-0240. Expiration Date: 11/30/07. Need and Use of Information Collection: Food and Drug Administration (FDA) regulations require investigators to establish a record of the receipt, use and disposition of all investigational agents. The National Cancer Institute, (NCI), as a sponsor of investigational drug trials, has the responsibility to assure the FDA that investigators in its clinical trials program are maintaining systems for drug accountability. In order to fulfill these requirements, a standard Investigational Drug Accountability Report Form (NIH 2564) was designed to account for drug inventories and usage by protocols. The data obtained from the drug accountability record will be used to keep track of the dispensing of investigational anticancer agents to patients. It is used by NCI management to ensure that investigational drug supplies are not diverted for inappropriate protocol or patient use. The information is also compared to patient flow sheets (protocol reporting forms) during site visits conducted for each investigator once every three years. All comparisons are done with the intention of ensuring protocol, patient and drug compliance for patient and drug compliance for patient safety and protections. Frequency of Response: Daily. Affected Public: State or local governments, businesses or other for-profit. Federal agencies or employees, non-profit institutions, and small business or organizations. Type of Respondents: Investigators, pharmacist, nurses, pharmacy technicians, data manager. The annual reporting burden is divided into two major areas. These are the audits of Drug Accountability Forms by Government and its contractors and the use of the forms by clinical research sites. The burden is as follows: Federal Burden: 1700 audits are conducted of clinical research sites, a minimum of three Drug Accountability Forms are reviewed at the audit. Each form requires \1/2\ hour to review. Number of Respondents: 1700. Number of Responses per Respondent: 3. Average Burden per Response: 0.5 hours. Annual Burden Hours: 2,250 hours. Clinical Trial Site Burden: The annual respondents' burden for record keeping is estimated to require 6,240 hours. The record keeping burden represents an average time required for multiple entries (6 minutes or 0.1 hour per entry) on the drug accountability form, the average number of forms maintained by each record keeper and the number of record keepers.

The Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) are seeking public comment on the draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine. The draft Guidance is now available on the HHS Web site.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Role of HIV Resistance Testing in Antiretroviral Drug Development.'' This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the agency's current thinking regarding the role of HIV resistance testing during antiretroviral drug development and postmarketing. This guidance discusses important nonclinical studies that are recommended before the initiation of phase 1 clinical studies in HIV-infected patients. In addition, this guidance addresses the use of resistance testing in clinical phases of drug development and recommends the type of information that should be collected and the types of analyses that should be conducted to characterize an antiretroviral's resistance profile. This guidance finalizes the draft guidance published on November 29, 2004.

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The draft guidance announced in this notice supersedes FDA's ``Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees,'' dated January 2002.

The Health Resources and Services Administration published a notice in the Federal Register of October 5, 2007 (FR Doc. E7-19747), on pages 57049-57052, regarding response to solicitation of comments and publication of final program eligibility guidelines.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing a notice of a proposal to add a new system of records. The Campus Based Branch (CBB) of the Division of Health Careers Diversity and Development in the Bureau of Health Professions is currently utilizing a document management system (DMS) that dynamically manages its flow of documents produced and received. the DMS is an intra-office system in which documents contained within the system are only shared among CBB staff. The DMS contains names and other personally identifiable information of borrowers.