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

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information is an amendment to OMB control number 0910-0167 and concerns the joint adoption by FDA and the European Medicines Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD.

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for oral pressurized metered-dose inhalers (MDIs) containing epinephrine. The proposed rule was published in the Federal Register of September 20, 2007 (72 FR 53711). Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking. In addition, the comment period on the proposed rule is being extended to December 19, 2007, to accommodate the meeting and to provide a short period after the meeting to receive additional comments.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a one percent ivermectin solution by subcutaneous injection.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the NIH Undergraduate Scholarship Program, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. Proposed Collection: Title: National Institutes of Health Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds (UGSP). Type of Information Collection Request: Extension of a previously approved collection (OMB No. 0925-0438, expiration date July 31, 2004). Form Numbers: NIH 2762-1, NIH 2762-2, NIH 2762-3, NIH 2762-4, and NIH 2762-5. Need and Use of Information Collection: The NIH makes available scholarship awards to students from disadvantaged backgrounds who are committed to careers in biomedical research. The scholarships pay for tuition and reasonable educational and living expenses up to $20,000 per academic year at an accredited undergraduate institution. In return, for each year of scholarship support, the recipient is obligated to serve as a full-time paid employee in an NIH research laboratory for 10 consecutive weeks during the months of June through August and for one year after graduation. If the recipient is enrolled in an undergraduate program or pursues a postgraduate degree (doctoral, medical, dental, or veterinarian school), the postgraduation service obligation may be deferred with the approval of the Secretary of Health and Human Services. The information proposed for collection will be used by the NIH Undergraduate Scholarship Program to determine an applicant's eligibility for participation in the UGSP and a participant's eligibility to defer his or her service obligation. The UGSP is authorized by Section 487D of the Public Health Service (PHS) Act (42 U.S.C. 288-2), as amended by the NIH Revitalization Act of 1993 (Pub. L. 103-43). Frequency of Response: Initial application and annual renewal application. Affected Public: Applicants (high school or undergraduate students), recommenders, undergraduate institution financial aid staff, participants wishing to defer their service obligation, and graduate or undergraduate registrar staff. The annual reporting burden estimates are as follows:

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 Cancer Institute (NCI), 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: NIH-American Association for Retired Persons (AARP) Short Follow-Up Questionnaire 2008. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this short 2-page questionnaire is to obtain information on 18 different medical conditions, several medical procedures, and lifestyle characteristics from 513,225 participants of the NIH-AARP Diet and Health Study. The questionnaire will support the ongoing examination between cancer and nutritional exposures. This questionnaire adheres to The Public Health Service Act, section 412 (42 U.S.C. 285a-1) and section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-85). The annual reporting burden is as follows: Estimated Number of Respondents: 513,225; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .0668; and Estimated Total Annual Burden Hours Requested: 34,283. The annualized cost to respondents is estimated at: $302,158. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

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 Heart, Lung, and Blood Institute (NHLBI), 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: The Framingham Study. Type of Information Request: Revision (OMB No. 0925-0216). Need and Use of Information Collection: The Framingham Study will conduct examinations and morbidity and mortality follow-up in original, offspring, and third generation participants for the purpose of studying the determinants of cardiovascular disease. Frequency of response: The participants will be contacted annually. Affected public: Individuals or households; businesses or other for profit; small businesses or organizations. Types of Respondents: Adult men and women; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 6,000 and Estimated Total Annual Burden Hours Requested: 9,900. There are no capital, operating, or maintenance costs to report.

In compliance with Section 350(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (72 FR 45054) on August 10, 2007 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0006, ``Application for Participation in the IHS Scholarship Program.'' Type of Information Collection Request: Previously Approved Collection. Form Number(s): IHS-856, 856-2 through 856-8, IHS-815, IHS-816, IHS-817, IHS-818, D-02, F-02, F-04, G-02, G-04, H-07, H-08, J-04, J-05, K-03, K-04, and L-03. Reporting formats are contained in an IHS Scholarship Program application booklet. Need and Use of Information Collection: This IHS Scholarship Branch needs this information for program administration and uses the information to solicit, process, and award IHS Pre- graduate, Preparatory, and/or Health Professions Scholarship grants and monitor the academic performance of awardees, to place awardees at payback sites. The IHS Scholarship Program plans to streamline the application to reduce the time needed by applicants to complete and provide the information. The IHS Scholarship Program plans to use information technology to make the application electronically available on the internet have been delayed. Affected Public: Individuals, non-for-profit institutes and State, local or Tribal Government. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).

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.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications'' dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005.

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 Combustion Engineering, Windsor, Connecticut, 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: Combustion Engineering. Location: Windsor, Connecticut. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1965 through December 31, 1972.

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 Horizons, Inc., Cleveland, Ohio, 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: Horizons, Inc. Location: Cleveland, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1944 through December 31, 1956; and January 1, 1957 through July 31, 2006 (residual period).

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 the Westinghouse Atomic Power Development Plant, East Pittsburgh, Pennsylvania, 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: Westinghouse Atomic Power Development Plant. Location: East Pittsburgh, Pennsylvania. Job Titles and/or Job Duties: All testers and laboratory researchers (to include research group leaders who worked in the L Building (and K Building as applicable). Period of Employment: January 1, 1942 through December 31, 1944.

On March 30, 2007, we published a final rule entitled ``Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants.'' The effective date was June 28, 2007. This correcting amendment corrects a technical error identified in the March 30, 2007 final rule.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on August 21, 2007, pages 46640-46641, and allowed 60 days for public comment. No 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: The Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Collection Request: Renewal (OMB No. 0925-0493). Need and Use of Information Collection: This project identifies and quantifies factors associated with the presence and progression of subclinical cardiovascular disease (CVD)that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 550; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: .2; and Estimated Total Annual Burden Hours Requested: 36.7. The annualized cost to respondents is estimated at $5,595, assuming respondents time at the rate of $18.65 per hour and physician time at the rate of $75 per hour. 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 it intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after April 28, 2008. FDA intends to exercise its enforcement discretion with respect to unapproved pancreatic enzyme drug products until April 28, 2010, if the manufacturers have investigational new drug applications (INDs) on active status on or before April 28, 2008, and have submitted new drug applications (NDAs) on or before April 28, 2009. FDA is granting this extension to ensure the availability of exocrine pancreatic insufficiency drug products during the additional time needed by manufacturers to obtain marketing approval.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting on updating the NIOSH publication ``Occupational Exposure Sampling Strategies Manual''. The document can be found at https://www.cdc.gov/niosh/docs/77-173/. Instructions are provided for submitting comments. Public Meeting Dates and Times: November 8, 2007, 8:30 a.m. to 4:30 p.m. EST and November 9, 2007, 8:30 a.m. to 12 p.m. EST. Place: Washington Court Hotel, 525 New Jersey Avenue, NW., Washington, DC 20001. Purpose of Meeting: To obtain input from stakeholders on their needs for information and guidance to be included in a revision of the ``Occupational Exposure Sampling Strategies Manual'' (OESSM), which is sometimes referred to as ``Leidel, Busch and Lynch'' or ``The NIOSH Yellow Book'' [https://www.cdc.gov/niosh/77-173.html]. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Persons wanting to attend and contribute comments at the meeting are requested to register at https://www.team-psa.com/niosh-OESSM07/home.asp no later than November 1, 2007. Unreserved walk-in attendees will be accommodated on the day of the meeting if space is available. The meeting has several scheduled presentations and panels that will include time for questions and answers. In addition, two breakout sessions will be held to solicit discussion and input on specific occupational exposure issues. Presentations, questions, and oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C- 34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091 and must be submitted by November 30, 2007 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-091. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the current practice, limitations, and needs for development of occupational exposure assessment practices and policies. NIOSH will use this information to assess the needs and scientific basis for revisions to its guidance and recommendations in occupational exposure assessment. Contact Person for Technical Information: Paul Middendorf, telephone (513)533-8606, M/S C-9, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Contact Person for Submitting Comments/Meeting Attendance: Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

The Food and Drug Administration (FDA) is announcing the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this document were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) from Schering-Plough Animal Health Corp. to Huvepharma AD.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five approved new animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (``Lookback'')'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the list of proposed substances that will be evaluated for CERCLA Set 22 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.

The Food and Drug Administration (FDA) is issuing this notice to explain the new direct-to-consumer (DTC) user fee program (DTC user fee program) established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and, as required by the new law, to ask companies to notify FDA within 30 calendar days if they intend to participate in the DTC user fee program during fiscal year (FY) 2008 and, if they do plan to participate, to identify the number of DTC television advertisements for prescription drug and biological products they plan to submit for advisory review during FY 2008. The information gathered in response to this notice will be used to establish the FY 2008 fee that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. The proposed information collection was previously published in the Federal Register on July 25, 2007, in Volume 72, No. 142, pages 40887-40888, 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 NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NICHD Research Partner Satisfaction Surveys. Type of Information Collection Request: Extension without change. Need and Use of Information Collection: Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NICHD seeks to obtain OMB's generic approval to conduct customer satisfaction surveys surrounding its research programs and activities. The NICHD was founded in 1963. Its mission is to ensure, through research, the birth of healthy infants and the opportunity for each to reach full potential in adulthood, unimpaired by physical or mental disabilities. The NICHD conducts and supports research on the many factors that protect and enhance the process of human growth and development. The developmental focus of the NICHD means that its research portfolio is unusually broad. NICHD programs include research on infant mortality, birth defects, learning disorders, developmental disabilities, vaccine development, and demographic and behavioral sciences, among others. In addition to supporting basic research, clinical trials, and epidemiological studies that explore health processes, the NICHD forms partnerships with organizations or institutions to ensure effective use of scientific findings and research products. The NICHD utilizes strategic assessments to support Institute planning and policy development, and to help determine programmatic and scientific objectives and priorities. Research partner surveys will augment NICHD's ongoing efforts to assess research-related activities. The two principal objectives are: (1) To measure the personal satisfaction of research partners with NICHD programs or initiatives, including both responsiveness to scientific aims and convenience of operations to support research and its effective use; and (2) to learn from research partners the ways in which the NICHD can improve the overall planning and management of it programs and initiatives. Findings will be used to improve NICHD's research programs and initiatives in the following ways: (1) To assess the effectiveness and efficiency of operations; (2) to identify opportunities for improving program performance; (3) to develop plans to incorporate innovations in program management; (4) to measure partner satisfaction and document program outcomes for governmental accountability reporting; and (5) to identify the need for creating new programs or initiatives or restructuring existing ones to respond to emerging scientific opportunities. Frequency of Response: Annual [As needed on an ongoing and concurrent basis]. Affected Public: Members of the public, researchers, practitioners, and other health professionals. Type of Respondents: Members of the public; eligible grant applicants and actual applicants (both successful and unsuccessful); clinicians and other health professionals; and actual or potential clinical trials participants. The annual reporting burden is as follows: Estimated Number of Respondents: 28,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: Varies with survey type, see below; and Estimated Total Annual Burden Hours Requested: 5,883. The annualized cost to respondents is estimated at: $109,541.46. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing a public hearing concerning FDA's policies regarding salt (sodium chloride) and sodium in food. FDA also is announcing the availability for comment of a citizen petition, submitted by the Center for Science in the Public Interest (CSPI), requesting that FDA make changes to the regulatory status of salt, require limits on salt in processed foods, and require health messages related to salt and sodium. The purpose of the hearing is for FDA to share its current framework of policies regarding salt and sodium and to solicit information and comments from interested persons on this current framework and on potential future approaches, including approaches described in the citizen petition.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to- Consumer (DTC) Print Advertisements for Prescription Drugs'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.