Agency Information Collection Activities: Submission for OMB Review; Comment Request, 61485 [E6-17318]

Download as PDF 61485 Federal Register / Vol. 71, No. 201 / Wednesday, October 18, 2006 / Notices Submit written requests for single copies of the summaries to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please specify by product name which summary or summaries you are requesting. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6460,Silver Spring, MD 20993–0002, 301–796–0700, e-mail: grace.carmouze@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for ALTACE (ramipril), GEMZAR (gemcitabine), LESCOL (fluvastatin), SANDOSTATIN LAR (octreotide), and SEREVENT (salmeterol). The summaries are being made available consistent with section 9 of the BPCA (Public Law 107–109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the act permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet at http://www.fda.gov/ cder/pediatric/index.htm summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ALTACE (ramipril), GEMZAR (gemcitabine), LESCOL (fluvastatin), SANDOSTATIN LAR (octreotide), and SEREVENT (salmeterol). Copies are also available by mail (see ADDRESSES). II. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/cder/pediatric/index.htm. Dated: October 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–17284 Filed 10–17–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Proposed Project: National Health Service Corps Travel Request Worksheet (OMB No. 0915–0278): Extension Clinicians participating in the HRSA National Health Service Corps (NHSC) Scholarship Program use the Travel Request Worksheet to receive travel funds from the Federal Government to perform pre-employment interviews at sites on the Approved Practice List. The travel approval process is initiated when a scholar notifies the NHSC’s InService Support Branch of an impending interview at one or more NHSC approved practice sites. The Travel Request Worksheet is also used to initiate the relocation process after a NHSC scholar has successfully been matched to an approved practice site. Upon receipt of the Travel Request Worksheet, the NHSC will review and approve or disapprove the request and promptly notify the NHSC contractor regarding authorization of the funding for the relocation. The burden estimate for the project is as follows: Periodically, the Health Resources and Services Administration (HRSA) Number of respondents Form Responses per respondent 250 2 Worksheet ................................................................................................ rmajette on PROD1PC67 with NOTICES1 publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)-443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: October 6, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6–17318 Filed 10–17–06; 8:45 am] BILLING CODE 4165–15–P Total responses 500 15:24 Oct 17, 2006 Jkt 211001 PO 00000 Total burden hours .06 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Notice of Program Exclusions AGENCY: Office of Inspector General, HHS. ACTION: VerDate Aug<31>2005 Hours per response Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM Notice of program exclusions. 18OCN1 30

Agencies

[Federal Register Volume 71, Number 201 (Wednesday, October 18, 2006)]
[Notices]
[Page 61485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17318]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301)-443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: National Health Service Corps Travel Request 
Worksheet (OMB No. 0915-0278): Extension

    Clinicians participating in the HRSA National Health Service Corps 
(NHSC) Scholarship Program use the Travel Request Worksheet to receive 
travel funds from the Federal Government to perform pre-employment 
interviews at sites on the Approved Practice List. The travel approval 
process is initiated when a scholar notifies the NHSC's In-Service 
Support Branch of an impending interview at one or more NHSC approved 
practice sites.
    The Travel Request Worksheet is also used to initiate the 
relocation process after a NHSC scholar has successfully been matched 
to an approved practice site. Upon receipt of the Travel Request 
Worksheet, the NHSC will review and approve or disapprove the request 
and promptly notify the NHSC contractor regarding authorization of the 
funding for the relocation.
    The burden estimate for the project is as follows:

----------------------------------------------------------------------------------------------------------------
                                                               Responses                                Total
                      Form                        Number of       per         Total      Hours  per     burden
                                                 respondents   respondent   responses     response      hours
----------------------------------------------------------------------------------------------------------------
Worksheet......................................          250            2          500          .06           30
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
John Kraemer, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC 
20503.

    Dated: October 6, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-17318 Filed 10-17-06; 8:45 am]
BILLING CODE 4165-15-P