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12178 Federal Register / Vol. 72, No.

50 / Thursday, March 15, 2007 / Notices

Management Analysis and Services Office, Matters to be Discussed: The meeting DATES: Fax written comments on the
CDC, pursuant to Public Law 92–463. will include the review, discussion, and collection of information by April 16,
Matters To Be Discussed: The meeting will evaluation of applications received in 2007.
include the review, discussion, and
evaluation of scientific merit of grant
response to RFA OH 07–002,
‘‘Childhood Agriculture Safety and ADDRESSES: To ensure that comments on
applications received in response to RFA the information collection are received,
DD07–006, ‘‘China-United States Health Research.’’
Collaborative, Population-Based Surveillance Contact Person For More Information: OMB recommends that written
and Research Program for Maternal-Child Stephen Olenchock, Scientific Review comments be faxed to the Office of
and Family Health.’’ Administrator, Office of Extramural Information and Regulatory Affairs,
For Further Information Contact: Juliana Coordination and Special Projects, OMB, Attn: FDA Desk Officer, FAX:
Cyril, Ph.D., Scientific Review Administrator, 202–395–6974.
National Institute for Occupational
Centers for Disease Control and Prevention,
1600 Clifton Road NE, Mailstop D72, Atlanta, Safety and Health, CDC, 1095 FOR FURTHER INFORMATION CONTACT:
GA 30333, Telephone 404.639.4639. Willowdale Road, Mailstop P–04, Denver Presley, Jr., Office of the Chief
The Director, Management Analysis and Morgantown, WV 26506, Telephone Information Officer (HFA–250), Food
Services Office, has been delegated the 304–285–6271. and Drug Administration, 5600 Fishers
authority to sign Federal Register notices The Director, Management Analysis Lane, Rockville, MD 20857, 301– 827–
pertaining to announcements of meetings and and Services Office, has been delegated 1472.
other committee management activities, for the authority to sign Federal Register
both CDC and the Agency for Toxic SUPPLEMENTARY INFORMATION: In
Substances and Disease Registry. notices pertaining to announcements of
meetings and other committee compliance with 44 U.S.C. 3507, FDA
Dated: March 8, 2007. management activities, for both CDC has submitted the following proposed
Elaine L. Baker, and the Agency for Toxic Substances collection of information to OMB for
Acting Director, Management Analysis and and Disease Registry. review and clearance.
Services Office, Centers for Disease Control Substances Prohibited from Use in
and Prevention. Elaine L. Baker,
Animal Food or Feed; Animal Proteins
[FR Doc. E7–4744 Filed 3–14–07; 8:45 am] Acting Director, Management Analysis and
Services Office, Centers for Disease Control
Prohibited in Ruminant Feed—21 CFR
BILLING CODE 4163–18–P 589.2000(e)(1)(iv) (OMB Control
and Prevention.
[FR Doc. E7–4745 Filed 3–14–07; 8:45 am]
Number 0910–0339)—Extension
DEPARTMENT OF HEALTH AND BILLING CODE 4163–18–P This information collection was
HUMAN SERVICES established because epidemiological
evidence gathered in the United
Centers for Disease Control and DEPARTMENT OF HEALTH AND Kingdom suggested that bovine
Prevention HUMAN SERVICES spongiform encephalopathy (BSE), a
Disease, Disability, and Injury progressively degenerative central
Food and Drug Administration
Prevention and Control Special nervous system disease, is spread to
Emphasis Panel (SEP): Childhood [Docket No. 2006N–0472] ruminant animals by feeding protein
Agriculture Safety and Health derived from ruminants infected with
Research, Request for Applications Agency Information Collection BSE. That regulation places general
(RFA) OH 07–002 Activities; Submission for Office of requirements on persons that
Management and Budget Review; manufacture, blend, process, and
In accordance with Section 10(a)(2) of Comment Request; Substances distribute products that contain or may
the Federal Advisory Committee Act Prohibited From Use in Animal Food or contain protein derived from
(Pub. L. 92–463), the Centers for Disease Feed; Animal Proteins Prohibited in mammalian tissue, and feeds made from
Control and Prevention (CDC) Ruminant Feed such products.
announces the aforementioned meeting. In the Federal Register of December 4,
Time and Date: 1 p.m.–3 p.m., April AGENCY: Food and Drug Administration,
HHS. 2006 (71 FR 70409), FDA published a
16, 2007 (Closed).
Place: Teleconference. 60-day notice requesting public
ACTION: Notice.
Status: The meeting will be closed to comment on the information collection
the public in accordance with SUMMARY: The Food and Drug provisions. No comments were received.
provisions set forth in Section 552b(c) Administration (FDA) is announcing The respondents for this collection of
(4) and (6), Title 5 U.S.C., and the that a proposed collection of information are manufacturers and or
Determination of the Director, information has been submitted to the distributors of products that contain or
Management Analysis and Services Office of Management and Budget may contain protein derived from
Office, CDC, pursuant to Public Law 92– (OMB) for review and clearance under mammalian tissues and feeds made
463. the Paperwork Reduction Act of 1995. from such products.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Recordkeepers per Recordkeeping Records Record

589.2000(e)(1)(iv) 400 1 400 14 5,600


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1There are no capital costs or operating and maintenance costs associated with this collection of information.

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Federal Register / Vol. 72, No. 50 / Thursday, March 15, 2007 / Notices 12179

Dated: March 7, 2007. Dockets Management (HFA–305), Food Register, and FDA believes that the
Jeffrey Shuren, and Drug Administration, 5630 Fishers Internet is accessible to more people
Assistant Commissioner for Policy. Lane, rm. 1061, Rockville, MD 20852. than the Federal Register.
[FR Doc. E7–4685 Filed 3–14–07; 8:45 am] Please include the appropriate docket In accordance with section 515(d)(4)
BILLING CODE 4160–01–S
number as listed in tables 1 and 2 of this and (e)(2) of the Federal Food, Drug, and
document when submitting a written Cosmetic Act (the act) (21 U.S.C.
request. See the SUPPLEMENTARY 360e(d)(4) and (e)(2)), notification of an
DEPARTMENT OF HEALTH AND INFORMATION section for electronic
order approving, denying, or
HUMAN SERVICES access to the summaries of safety and
withdrawing approval of a PMA will
effectiveness data.
continue to include a notice of
Food and Drug Administration FOR FURTHER INFORMATION CONTACT:
opportunity to request review of the
[Docket Nos. 2006M–0384, 2006M–0385, Nathaniel L. Geary, Center for Biologics order under section 515(g) of the act.
2006M–0386] Evaluation and Research (HFM–17), The 30-day period for requesting
Food and Drug Administration, suite administrative reconsideration of an
Medical Devices Regulated by the 200N, 1401 Rockville Pike, Rockville,
FDA action under § 10.33(b) (21 CFR
Center for Biologics Evaluation and MD 20852–1448, 301–827–6210.
10.33(b)) for notices announcing
Research; Availability of Summaries of SUPPLEMENTARY INFORMATION: approval of a PMA begins on the day the
Safety and Effectiveness Data for notice is placed on the Internet. Section
I. Background
Premarket Approval Applications 10.33(b) provides that FDA may, for
In the Federal Register of January 30,
AGENCY: Food and Drug Administration, 1998 (63 FR 4571), FDA published a good cause, extend this 30-day period.
HHS. final rule that revised 21 CFR 814.44(d) Reconsideration of a denial or
ACTION: Notice. and 814.45(d)) to discontinue individual withdrawal of approval of a PMA may
publication of PMA approvals and be sought only by the applicant; in these
SUMMARY: The Food and Drug denials in the Federal Register, cases, the 30-day period will begin
Administration (FDA) is publishing a providing instead to post this when the applicant is notified by FDA
list of premarket approval applications information on the Internet at http:// in writing of its decision.
(PMAs) that have been approved by the www.fda.gov. In addition, the The following is a list of PMAs
Center for Biologics Evaluation and regulations provide that FDA publish a approved by CBER for which summaries
Research (CBER). This list is intended to quarterly list of available safety and of safety and effectiveness data were
inform the public of the availability effectiveness summaries of PMA placed on the Internet from March 1,
through the Internet and the FDA’s approvals and denials that were 2006, through June 30, 2006, and from
Division of Dockets Management of announced during the quarter. FDA July 1, 2006, through September 30,
summaries of safety and effectiveness believes that this procedure expedites 2006. There were no denial actions
data of approved PMAs. public notification of these actions during either period. The list provides
ADDRESSES: Submit written requests for because announcements can be placed the manufacturer’s name, the product’s
copies of summaries of safety and on the Internet more quickly than they generic name or the trade name, and the
effectiveness data to the Division of can be published in the Federal approval date.

TABLE 1.—LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE MARCH
1, 2006, THROUGH JUNE 30, 2006
PMA No./Docket No. Applicant Trade Name Approval Date

BP050009/0/2006M–0384 Chembio Diagnostic Systems, Inc. SURE CHECK HIV 1/2 ASSAY May 25, 2006

BP050010/0/2006M–0385 Chembio Diagnostic Systems, Inc. HIV 1/2 STAT–PAKT ASSAY May 25, 2006

TABLE 2.—LIST SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE JULY 1,
2006, THROUGH SEPTEMBER 30, 2006
PMA No./Docket No. Applicant Trade Name Approval Date

BP050030/0/2006M–0386 Bayer Healthcare LLC ADVIA Centaur HIV 1/0/2 En- May 18, 2006
hanced Assay

II. Electronic Access DEPARTMENT OF HOMELAND ACTION: Notice of partially closed


SECURITY advisory committee meeting.
Persons with access to the Internet
may obtain the documents at http:// National Communications System SUMMARY: The President’s National
www.fda.gov/cber/products.htm. Security Telecommunications Advisory
Dated: March 5, 2007. [Docket No. NCS–2007–0001] Committee (NSTAC) will be meeting by
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Jeffrey Shuren, teleconference: the meeting will be


National Security Telecommunications partially closed.
Assistant Commissioner for Policy. Advisory Committee
[FR Doc. E7–4677 Filed 3–14–07; 8:45 am] DATES: Thursday, March 29, 2007, from
BILLING CODE 4160–01–S AGENCY: National Communications 2 p.m. until 3 p.m.
System, DHS.

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