Notice of Establishment, 51288 [E9-23974]

Download as PDF 51288 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response Total Annual Responses 571.1(c) moderate category 1 1 1 3,000 3,000 571.1(c) complex category 1 1 1 10,000 10,000 571.6 amendment of petition 2 2 4 1,300 5,200 21 CFR Section Hours per Response Total Hours 1 There 18,200 are no capital costs or operating and maintenance costs associated with this collection of information. FDA derived the annual reporting burden estimate for the different categories as follows: Section 571.1(c)—moderate category: For food additive petition without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per petition is approximately 3,000 hours. An average of 1 (one) petitions of this type is received on an annual basis, resulting in a burden of 3,000 hours. Section 571.1(c)—complex category: For a food additive petition with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. An average of 1 (one) petition of this type is received on an annual basis, resulting in a burden of 10,000 hours. Section 571.6: For a food additive petition amendment, the estimated time requirement per petition is approximately 1,300 hours. An average of 4 (four) petitions of this type is received on an annual basis, resulting in a burden of 5,200 hours. Thus, the estimated total annual burden for this information collection is 18,200 hours. Dated: September 29, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–24047 Filed 10–05–09; 8:45 am] and Human Services to share and coordinate information on existing research activities, and make recommendations to the Secretary DHHS, the National Institutes of Health and other Federal agencies regarding how to improve existing research programs. The Committee’s primary mission is to facilitate the efficient and effective exchange of information on breast cancer research activities among the member agencies, and to coordinate solicitation of proposals for collaborative, multidisciplinary research, including proposals to evaluate environmental and genomic factors that may be related to the etiology of breast cancer. Duration of this committee is two years from the date the Charter is filed. Francis S. Collins, Director, National Institutes of Health. [FR Doc. E9–23974 Filed 10–5–09; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration BILLING CODE 4160–01–S [Docket Nos. FDA–2009–M–0033, FDA– 2009–M–0016, FDA–2009–M–0034, FDA– 2009–M–0049, FDA–2009–M–0071, FDA– 2009–M–0127, FDA–2009–M–0128, FDA– 2009–M–0135, FDA–2009–M–0159] DEPARTMENT OF HEALTH AND HUMAN SERVICES Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: National Institutes of Health Food and Drug Administration, HHS. Notice. Notice of Establishment jlentini on DSKJ8SOYB1PROD with NOTICES Total Hours ACTION: Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), announces the establishment of the Interagency Breast Cancer and Environmental Research Coordinating Committee (Committee). The Committee shall coordinate all efforts within the Department of Health SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency’s Division of Dockets Management. VerDate Nov<24>2008 16:15 Oct 05, 2009 Jkt 220001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301–796– 6570. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency now posts this information on the Internet on FDA’s home page at https://www.fda.gov. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Page 51288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23974]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of Establishment

    Pursuant to the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), 
announces the establishment of the Interagency Breast Cancer and 
Environmental Research Coordinating Committee (Committee).
    The Committee shall coordinate all efforts within the Department of 
Health and Human Services to share and coordinate information on 
existing research activities, and make recommendations to the Secretary 
DHHS, the National Institutes of Health and other Federal agencies 
regarding how to improve existing research programs.
    The Committee's primary mission is to facilitate the efficient and 
effective exchange of information on breast cancer research activities 
among the member agencies, and to coordinate solicitation of proposals 
for collaborative, multidisciplinary research, including proposals to 
evaluate environmental and genomic factors that may be related to the 
etiology of breast cancer.
    Duration of this committee is two years from the date the Charter 
is filed.

Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. E9-23974 Filed 10-5-09; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.