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.

The Food and Drug Administration (FDA) is extending to December 26, 2007, the comment period for the August 27, 2007, proposed rule to amend the final monograph for over-the-counter (OTC) sunscreen drug products (72 FR 49070). The comment period for the proposed rule was to end on November 26, 2007. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

In the Federal Register of October 4, 2007 (72 FR 56769), the Food and Drug Administration (FDA) published a notice that announced a public meeting to obtain comments regarding behind-the-counter (BTC) availability of human drugs. An incorrect date was published in that notice. This document clarifies that Docket No. 2007N-0356 will close on December 17, 2007.

The Food and Drug Administration (FDA) proposes to issue this rule finding that certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) and may not appear in food labeling. This rule is being proposed in response to three notifications submitted to FDA under the act. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). FDA has reviewed the information included in the three notifications and is proposing to prohibit the nutrient content claims for DHA and EPA set forth in the three notifications because they are not based on an authoritative statement that identifies a nutrient level to which the claims refer, as required by the controlling statutory authority. FDA is also proposing to prohibit the nutrient content claims for ALA set forth in the seafood processors notification because they are based on a daily value that was determined by a different method than daily values already established for other nutrients. Because of the different methodology used to set the daily value, the ALA claims set forth in the seafood processors notification do not enable the public to comprehend the information provided in the claims and to understand the relative significance of such information in the context of the daily diet, as required by the controlling statutory authority. FDA is proposing to take no regulatory action with respect to the nutrient content claims for ALA set forth in the Martek notification. Therefore, if this proposed rule is finalized without change, these claims will be allowed to remain on the market.

This notice solicits comments on the HRSA proposed uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for Fiscal Year 2008 and beyond. Title XXVI of the Public Health Service Act (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective Fiscal Year (FY) 2007. HRSA has issued guidance for obtaining a waiver for FY 2007 and seeks to issue waiver requirements for grantees under Parts A, B, and C of Title XXVI of the PHS Act for FY 2008 and future years.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. We describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2008. In addition, the rule sets forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system apply, and other pertinent rate setting information for the CY 2008 ASC payment system. Furthermore, this final rule with comment period will make changes to the policies relating to the necessary provider designations of critical access hospitals and changes to several of the current conditions of participation requirements. The attached document also incorporates the changes to the FY 2008 hospital inpatient prospective payment system (IPPS) payment rates made as a result of the enactment of the TMA, Abstinence Education, and QI Programs Extension Act of 2007, Public Law 110-90. In addition, we are changing the provisions in our previously issued FY 2008 IPPS final rule and are establishing a new policy, retroactive to October 1, 2007, of not applying the documentation and coding adjustment to the FY 2008 hospital-specific rates for Medicare-dependent, small rural hospitals (MDHs) and sole community hospitals (SCHs). In the interim final rule with comment period in this document, we are modifying our regulations relating to graduate medical education (GME) payments made to teaching hospitals that have Medicare affiliation agreements for certain emergency situations.

The Food and Drug Administration (FDA) has determined that ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per vial, sterile lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxaliplatin sterile lyophilized powder for injection, 50 and 100 mg/ vial.

NICEATM announces availability of the ICCVAM Test Method Evaluation Report: In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives (NIH Publication 07-4517). The report describes four ocular toxicity test methods evaluated by ICCVAM: (1) The Bovine Corneal Opacity and Permeability [BCOP] test, (2) the Isolated Chicken Eye [ICE] test, (3) the Isolated Rabbit Eye [IRE] test, and (4) the Hen's Egg TestChorioallantoic Membrane [HET- CAM]. The report includes ICCVAM's (a) final test method recommendations on the use of these four in vitro test methods, (b) recommended test method protocols for future testing, (c) recommendations for further optimization and validation studies for these test methods, and (d) recommended reference substances for validation studies. The report recommends that the BCOP and ICE methods, with specific limitations for certain chemical classes and/or physical properties, can be used in a tiered testing strategy to determine ocular hazards, and substances that test positive can be classified as ocular corrosives or severe irritants without further testing in animals. The report also recommends that these in vitro test methods should be considered before using animals for ocular testing and used when determined appropriate. NICEATM also announces availability of the final Background Review Documents (BRDs) for the BCOP, ICE, IRE, and HET-CAM test methods (NIH Publications 06-4512, 06-4513, 06-4514, and 06-4515, respectively). These BRDs provide the data and analyses used to assess the current validation status of these four test methods for identifying ocular corrosives and severe irritants. Electronic copies of the ICCVAM Test Method Evaluation Report and the four BRDs are available from the NICEATM/ICCVAM Web site at https:// iccvam.niehs.nih.gov or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT). The ICCVAM Test Method Evaluation Report and the final BRDs have been forwarded to U.S. Federal agencies for regulatory and other acceptance considerations where applicable. Responses will be posted on the ICCVAM/NICEATM Web site as they are received.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (93) entitled ``Impurities in New Veterinary Medicinal Products (Revision)'' VICH GL11(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention.'' In this draft guidance, FDA provides recommendations on the development of drugs to be used to treat or prevent smallpox (variola) infection. This guidance is intended to help sponsors plan and design appropriate studies during the development of these drugs.

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 extending the expiration date of the compliance policy guide (CPG) entitled ``Sec. 400.210Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2008.

This proposed rule would permit a waiver of nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173, enacted December 8, 2003.) In addition, this proposed rule would codify an additional statutory provision enacted by section 4755 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) that requires the State to establish a procedure to permit a nurse aide to petition the State to have a single finding of neglect removed from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect involved in the original finding was a single occurrence.

This notice announces a listening session being conducted as part of the selection of Hospital-Acquired Conditions (HAC) and implementation of Present on Admission (POA) Indicator Reporting, as authorized by section 5001(c) of the Deficit Reduction Act of 2005 (DRA). The purpose of this listening session is to solicit informal comments in preparation for the fiscal year 2009 inpatient prospective payment system (IPPS) rulemaking process. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and all interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. However, because of time constraints, telephone participants will not be able to make verbal comments. Informal written comments will be accepted. This meeting is open to the public, but registration is required due to limited space and security requirements to enter the meeting location. This Listening Session is being held as a joint partnership between the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention.

This notice announces the new date for the Bidder's Conference for the Medicare Clinical Laboratory Services Competitive Bidding Demonstration project.

This notice announces the 18th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

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(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), 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: Pilot Study for the National Children's Study, Type of Information Collection Request: NEW, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18-49 years of age, their husbands or partners, and their children who live in selected areas within the seven (7) National Children's Study Vanguard sites enumerated below. A small number of health care professionals, community leaders, and child care personnel are also potential respondents. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of this Study is to pilot test protocols, policies, and procedures for the National Children's Study (NCS) with the goal of improving the efficiency of study procedures and enhancing the subsequent implementation of the NCS. The NCS is a long- term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. The Act specifies a broad definition of environment, including biologic, chemical, physical, and psycho-social factors and authorizes NICHD to plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of those exposures on child health and human development. This data collection will test procedures for population-based sampling and recruitment of pregnant women and women of child-bearing age, test study logistics, and estimates of subject burden, and evaluate data collection strategies including interviews and acquisition of biologic and environmental samples. In addition, participants will also be asked to provide qualitative and quantitative input on their feelings regarding participation in this Study, to enhance the lessons that can be learned and applied to improve the efficiency of the full NCS. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: https://nationalchildrensstudy.gov. This Pilot Study will be carried out in the seven NCS ``Vanguard'' locations previously selected as the initial study sites. These sites are Orange County, CA; Duplin County, NC; Queens County, NY; Montgomery County, PA; Salt Lake County, UT; Waukesha County, WI; and the aggregate of Lincoln, Pipestone, and Yellow Medicine Counties, MN and Brookings County, SD. This data collection is intended to begin with household enumeration and enrollment of women, proceed through pregnancy and birth, and continue with follow-up of children for up to 21 years. This application is for the first three years of data collection, which includes data collection through the visits at which some of the children will be 24 months old. Details of data collections beyond this period will be addressed at the time of renewal or in future applications. Women who are pregnant will be eligible for participation if, at the time of household enumeration and screening, they are within the first trimester of pregnancy. Women who are not pregnant will be eligible if, at the time of household enumeration and screening, they are 18-49 years of age, are neither surgically nor medically sterile, and can participate in the consent process. A subset of age-eligible women with a high likelihood of pregnancy (e.g., planning to become pregnant) will be enrolled to enable assessment of peri-conceptional exposures, should they become pregnant. The remainder of the study population will comprise women enrolled early in pregnancy. The seven centers combined will follow approximately 1000 infants born to women enrolled in the first year of this Pilot Study. Infants born to women enrolled in this Pilot Study but born after the eligibility period for the Pilot will be eligible for enrollment in the full NCS. The schedule of participant contacts for this data collection includes home visits, clinic visits, and phone contacts, and is described in the NCS Research Plan: https://nationalchildrensstudy.gov. Home visits before and during pregnancy will include collection of interview data, environmental specimens such as air and dust samples, maternal and paternal biospecimens such as blood and hair samples, and a brief physical examination including anthropometric measures and blood pressure. During pregnancy, women will receive up to three fetal ultrasounds to assess fetal growth. At birth, cord blood and placental samples will be collected and the infant will receive a brief developmental assessment. During infancy, home visits will include collection of interview data, environmental specimens, biospecimens from the infant and parents, a brief physical examination of the infant, and assessment of infant development and parental-infant interactions. Burden statement: The public burden for this Study will vary depending on the eligibility and pregnancy status of potential participants at the time of household screening. Women who are not pregnant at the time of screening will have varying burden depending on their likelihood of pregnancy and, should they become pregnant, the time to pregnancy. The burden for women enrolled during pregnancy will depend on when during pregnancy they are identified and enrolled in the Study. The table provides an annualized average burden per person for each stage of the Pilot Study over the three year period of the Study.

Under the provision of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 9, 2007, page 26399 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 October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Program Assessment and Evaluations for NIEHSAsthma Research. Type of Information Collection Request: NEW. New and Use of Information Collection: National Institute of Environmental Health Sciences, Division of Extramural Research and Training (DERT). DERT, with contract support from Battelle Centers for Public Health Research and Evaluation, is examining the impact of its research portfolio. Focusing specifically on one portion of the research portfolioasthma researchDERT proposes to supplement extant data sources with a primary data collection activity. The purpose of the proposed primary data collection is to obtain information from grantees regarding the impact of their funded asthma research in the short-, intermediate-, and long-term. This will be done through a survey of grantees that includes questions about the impact of funding on career development, the field of asthma research, public attitudes, commercial product development, clinical practice, business and industry practices, and long-term human and environmental health. Frequency of Response: One time. Affected Public: Individuals. Type of Respondents: Individuals receiving asthma funding. A 15-minute, close- ended, multi-mode (web and paper) survey will be administered to the universe of NIEHS-funded asthma researchers (N=179) and comparison agency asthma researchers (N=1371). Comparison agencies include other NIH institutes (NICHD, NIAID, NIA, NHLBI), the CDC, AHRQ, and the EPA. The survey development process included formative interviews with a small sample of NIEHS asthma researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1550; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 15 minutes; and Estimated Total Annual Burden Hours Requested: 387.5. The annualized cost to respondents is estimated at $13,039.38. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 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 Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Kellex/Pierpont, Jersey City, New Jersey, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Kellex/Pierpont. Location: Jersey City, New Jersey. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1943 through December 31, 1953.

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 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's recordkeeping and records access requirements for food facilities.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Association of American Feed Control Officials (AAFCO). The purpose of this MOU is to facilitate FDA's collaboration with AAFCO in the AAFCO New and Modified Ingredient Definition Process by clarifying the responsibilities of FDA and AAFCO in defining feed ingredients, in providing mechanisms for resolving disputes that may arise, and in providing mechanisms for modifying the ingredient definition process when required.

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: ``Voluntary Customer Surveys Generic Clearance for the Agency for Healthcare Research and Quality.'' 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. This proposed information collection was previously published in the Federal Register on August 3, 2007 and allowed 60 days for public comment. No comments were received. A 30-day Federal Register notice was published on October 11th, 2007 to allow an additional 30 days for public comment. No comments were received. However, changes to the estimated annual respondent burden hours and the methodologies that will be used for the data collection require an additional 30 days for public comment.

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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied the following patents or patent applications U.S. Patent No. 6,946,133 issued September 20, 2005 and U.S. Patent Application No. 11/606,929 filed December 1, 2006, as well as all continuations, divisionals, and issued and pending foreign counterparts [HHS Ref. No E-062-1996/0]; U.S. Patent Application Nos. 60/334,669 and 10/497,003 filed November 30, 2001 and August 24, 2004 respectively, as well as all continuations, divisionals, and issued and pending foreign counterparts [HHS Ref. No. E-124-2001/0, 1]; and U.S. Patent No. 6,165,460 issued December 26, 2000 and U.S. Patent Application No. 09/693,121 filed October 20, 2000; as well as all continuations, divisionals, and issued and pending foreign counterparts [HHS Ref. No E-200-1990/4] to BN ImmunoTherapeutics, which is located in Mountain View, CA. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for development of therapies for prostatic diseases. For the avoidance of doubt, said delivery formulation specifically excludes canary poxvirus vectors, NYVAC, eukaryotic expression vectors, aqueous-based delivery formulations, and recombinant yeast.

This final rule delays the date of applicability of certain specified compensation arrangements only, until December 4, 2008.

This notice announces the 20th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

Notice is hereby given that a single-source program expansion is being made to Public Strategies, Inc., as the National Healthy Marriage Resource Center (NHMRC), located in Oklahoma City, OK, in the amount of $1,250,000 to conduct a national media campaign on the value of marriage and the skills needed to increase marital stability and health. Public Strategies, Inc. and their collaborative partners were competitively awarded on September 30, 2006 to operate the NHMRC. The goal of the NHMRC is to be the ``first stop shop'' for marriage education information, an experienced provider of training and technical assistance, and a major catalyst in advancing the healthy marriage field. Since healthy marriage is a nascent field, it is necessary for the NHMRC to promote healthy marriage on a broad, national level in order to achieve these stated goals. Research has repeatedly shown that a healthy marriage brings about good outcomes for individuals, families, and especially, for children. A national media campaign would significantly raise the awareness of the benefits of healthy marriage and the benefits of marriage education. The campaign would disseminate information that explains how marriage education can enhance a couple's ability to form and sustain a healthy marriage and describe the benefits to children being raised in healthy, married two parent households. Additionally, by promoting healthy marriage and marriage education on a national level, the NHMRC will encourage a national discussion and further the mission of ACF's Healthy Marriage Initiative to help couples and individuals, who have chosen marriage for themselves, gain greater access to marriage education services, on a voluntary basis, where they can acquire the skills and knowledge necessary to form and sustain a healthy marriage. After the appropriate reviews, it has been determined that this single-source expansion qualifies for funding. The period of this funding will extend from September 30, 2007 through September 29, 2011.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing SOR titled, ``Individuals Authorized Access to Centers for Medicare & Medicaid Services (CMS) Computer Services (IACS), System No. 09-70-0064,'' most recently modified at 67 FR 48911 (July 26, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new identifying number for this system should read: System No. 09-70-0538. We propose to broaden the scope of this system to include a CMS service planned to provide a centralized user provisioning and administration service that supports the creation, deletion, and lifecycle management of enterprise identities. This service creates accounts, supports Role Based Access Control (RBAC), and provides business application integration points. RBAC is a form flow approval process and enterprise identity audit and recertification based on the role of the individual. The business application integration point allows business application owners to use the form flow process of the user provisioning service to approve or deny requests for access to business applications. This modification will permit CMS to implement a unified framework for managing user information and access rights, for those individuals who apply for and are granted access across multiple CMS systems and business contexts. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 2 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. Finally, we will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system has been to collect and maintain individually identifiable information to assign, control, track, and report authorized access to and use of CMS's computerized information and resources, for those individuals who apply for and are granted access across multiple CMS systems and business contexts. Information in this system will also be used to: (1) Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or CMS grantee; and (2) support litigation involving the Agency related to this system. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.