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

The National Institute of Mental Health (NIMH) is developing a strategic plan for the next 3-5 years, and invites the public to provide comments on a draft of this plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (https://www.nimh.nih.gov/about/strategic-planning-reports/nim h-draft- strategic-plan.shtml) from November 20, 2007 through December 21, 2007. The public is invited to provide comments via the e-mail address or the postal address listed on the NIMH Draft Strategic Plan Web page. Background: NIMH is the lead Federal agency for research on mental and behavioral disorders and has as its mission to reduce the burden of these disorders through research on mind, brain, and behavior. The Institute's goal is to generate research that will transform the prevention of and recovery from mental disorders. To inspire and support research that will make a difference for those living with mental illness, the Institute is developing a Strategic Plan to help direct this complex research effort and bring into sharper focus the methods, questions, and perspectives that will transform the diagnosis, treatment, and prevention of mental disorders, ultimately paving the way toward cures. NIMH's draft Strategic Plan outlines several Strategic Objectives that will guide the research agenda for the Institute over the next several years. The public is invited to review this draft plan and provide comments between November 20, 2007 and December 21, 2007. The draft plan may be viewed at https://www.nimh.nih.gov/about/strategic- planning-reports/nimh-draft-strategic-plan.shtml, and hard copies are available by calling 1-866-615-6464 (toll free) or by sending a letter requesting a copy (that includes your mailing address) to: National Institute of Mental Health, Attn: Draft Strategic Plan, 8280 Greensboro Drive, Suite 300, McLean, Virginia 22102. Request for Comments: The public is invited to provide comments on the draft Strategic Plan. Comments may be sent to the email address listed on the NIMH Strategic Planning Web page at https:// www.nimh.nih.gov/about/strategic-planning-reports/nimh-draft- strategic- plan.shtml, or sent to the postal address listed above.

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and- comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.

The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.

This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on September 5, 2007 entitled ``Medicare Program, Physicians'' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III).''

The Food and Drug Administration (FDA) is announcing that General Mills, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of ultraviolet radiation for the reduction of pathogens and other microorganisms in aqueous sugar solutions and potable water intended for use in food production.

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.

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.

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.

In compliance with the requirement of section 3506(copyright)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Fogarty International Center (FIC), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Process evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP). Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the outputs of the Global Health Research Initiative Program for New Foreign Investigators (GRIP) to date, assess the programs alignment with new strategic goals of the FIC, and identify potential directions for program enhancement. The primary objectives of the study are to determine if GRIP awards (1) promote productive re-entry of NIH-trained foreign investigators into their home countries, (2) increase the research capacity of the international scientists and institution, and (3) stimulate research on a wide variety of high priority health-related issues. The findings will provide valuable information concerning: (1) Specific research advances attributable to GRIP support; (2) specific capacity and career enhancing advances that are attributable to GRIP; (3) policy implications for GRIP at the program level based on survey responses, such as successes and challenges of the program's implementation, the GRIP support mechanism, etc. Frequency of Response: Once. Affected Public: None. Type of Respondents: Foreign researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 101; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.50; and Estimated Total Annual Burden Hours Requested: 50.5. The annualized cost to respondents is estimated at: $656.50. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Table 1 and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.

This document corrects technical errors that appeared in the August 3, 2007 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2008; Final Rule.''

The Food and Drug Administration (FDA) is reopening to January 15, 2008, the comment period for the notice of public hearing that published in the Federal Register of July 20, 2007. In the notice of public hearing, FDA requested comments on the use of symbols to communicate nutrition information on food labels. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the United States 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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in U.S. Patent No. 5,714,313, issued February 03, 1998, entitled ``Simple Method For Detecting Inhibitors Of Retroviral Replication'' (HHS Ref. E-054-1991/ 1-US-01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), having a place of business in France. The patent rights in these inventions have been assigned to the United States of America.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza. Amendment: Whereas, the H7 and H9 subtypes of avian influenza viruses are viewed as likely candidates to evolve into an influenza virus strain capable of causing a pandemic of human influenza; and Whereas, in accordance with section 319F-3(b)(6) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of these additional medical countermeasures with respect to the category of diseases and population described in sections II and IV of the declaration published in Federal Register on February 1, 2007 (72 FR 4710) (``the Original Declaration''); Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of the H7 and H9 subtypes of avian influenza viruses and resulting disease could in the future constitute a public health emergency. In order to reflect the addition of medical countermeasures specific to the H7 and H9 subtypes of influenza viruses, the Original Declaration is hereby amended as follows: First ``whereas'' clause, first sentence, insert ``H7 and H9 vaccines'' following ``(H5N1).'' Second ``whereas'' clause, first sentence, insert ``H7 and H9'' following ``H5N1'' to read ``Whereas an H5N1, [H7 and H9] avian influenza viruse[s] may evolve into strain[s] * * *.'' In Section I, paragraph 2, first sentence insert ``H7 and H9'' following ``(H5N1)'' to read ``* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s].'' In Section I, paragraph 2, third sentence insert ``H7 and H9'' following ``(H5N1)'' to read ``* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s] * * *.'' In Section II, paragraph 1, insert ``or an H7 or H9'' following ``(H5N1).'' In Section VIII, strike the sentence ``This Declaration has not previously been amended.'' and replace it with: ``This is the first amendment to this Declaration. The Original Declaration was published in the Federal Register at 72 FR 4710.'' All other provisions of the Original declaration remain in full force. This amendment to the Declaration will be published in the Federal Register pursuant to section 319F-3(b)(4) of the Act.

The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in soft- ripened cheese. The purpose of the risk assessment is to ascertain the impact on public health from the reduction and/or prevention of L. monocytogenes growth and recontamination during the manufacturing and/ or processing of soft-ripened cheese.