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21138 Federal Register / Vol. 73, No.

76 / Friday, April 18, 2008 / Notices

DEPARTMENT OF HEALTH AND (Pub. L. 92–463), the Centers for Disease be collected; and (4) the use of
HUMAN SERVICES Control and Prevention (CDC) automated collection techniques or
announces the aforementioned meeting. other forms of information technology to
Centers for Disease Control and Time and Date: 1 p.m.–2:30 p.m., May 22, minimize the information collection
Prevention 2008 (Closed). burden.
Place: Teleconference. 1. Type of Information Collection
Disease, Disability, and Injury Status: The meeting will be closed to the
Prevention and Control Special public in accordance with provisions set
Request: New collection; Title of
Emphasis Panel (SEP): Postpartum forth in Section 552b(c)(4) and (6), Title 5 Information Collection: Medicare
Hemorrhage Among Women with an U.S.C., and the Determination of the Director, Advantage (MA) Disclosure
Undiagnosed Bleeding Disorder, Management Analysis and Services Office, Requirements; Use: The information
Potential Extramural Projects (PEP) CDC, pursuant to Public Law 92–463. collection requirements are mandated
Matters to be Discussed: The meeting will by 42 CFR 422.111 and 422.80. MA
2008–R–28
include the review, discussion, and organizations will be required to notify
In accordance with Section 10(a)(2) of evaluation of ‘‘Evaluation of Breastfeeding
plan members of the coming year’s
the Federal Advisory Committee Act Promotion and Support Programs for African-
American Women, PEP 2008–R–25.’’ changes using a combined standardized
(Pub. L. 92–463), the Centers for Disease document. MA organizations and
Contact Person for More Information:
Control and Prevention (CDC) Linda Shelton, Program Specialist, potential MA organizations (applicants)
announces the aforementioned meeting. Coordinating Center for Health and will use the information to comply with
Time and Date: 1 p.m.–2 p.m., May 16, Information Service, Office of the Director, the eligibility requirements and the MA
2008 (Closed). CDC, 1600 Clifton Road, NE., Mailstop E21, contract requirements. CMS will use
Place: Teleconference. Atlanta, GA 30333, Telephone (404) 498– this information to ensure that correct
Status: The meeting will be closed to the 1194.
The Director, Management Analysis and
information is disclosed to Medicare
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5 Services Office, has been delegated the beneficiaries, both potential enrollees
U.S.C., and the determination of the Director, authority to sign Federal Register notices and enrollees. Form Number: CMS–
Management Analysis and Services Office, pertaining to announcements of meetings and 10260 (OMB# 0938–New); Frequency:
CDC, pursuant to Public Law 92–463. other committee management activities, for Yearly; Affected Public: Business or
Matters to be Discussed: The meeting will both CDC and the Agency for Toxic other for-profit; Number of
include the review, discussion, and Substances and Disease Registry. Respondents: 670; Total Annual
evaluation of ‘‘Postpartum Hemorrhage Dated: April 10, 2008. Responses: 670; Total Annual Hours:
Among Women with an Undiagnosed Elaine L. Baker, 8040.
Bleeding Disorder, PEP 2008–R–28.’’
Contact Person for More Information: Director, Management Analysis and Services To obtain copies of the supporting
Linda Shelton, Program Specialist, Office, Centers for Disease Control and statement and any related forms for the
Coordinating Center for Health and Prevention. proposed paperwork collections
Information Service, Office of the Director, [FR Doc. E8–8438 Filed 4–17–08; 8:45 am] referenced above, access CMS’ Web Site
CDC, 1600 Clifton Road, NE., Mailstop E21, BILLING CODE 4163–18–P address at http://www.cms.hhs.gov/
Atlanta, GA 30333, Telephone (404) 498– PaperworkReductionActof1995, or E-
1194.
The Director, Management Analysis and
mail your request, including your
DEPARTMENT OF HEALTH AND address, phone number, OMB number,
Services Office, has been delegated the HUMAN SERVICES
authority to sign Federal Register notices and CMS document identifier, to
pertaining to announcements of meetings and Centers for Medicare & Medicaid Paperwork@cms.hhs.gov, or call the
other committee management activities, for Services Reports Clearance Office on (410) 786–
both CDC and the Agency for Toxic 1326.
Substances and Disease Registry. [Document Identifier: CMS–10260] In commenting on the proposed
Dated: April 10, 2008. information collections please reference
Elaine L. Baker, Agency Information Collection
the document identifier or OMB control
Activities: Proposed Collection;
Director, Management Analysis and Services number. To be assured consideration,
Office, Centers for Disease Control and Comment Request
comments and recommendations must
Prevention. AGENCY: Centers for Medicare & be submitted in one of the following
[FR Doc. E8–8407 Filed 4–17–08; 8:45 am] Medicaid Services. ways by June 17, 2008:
BILLING CODE 4163–18–P In compliance with the requirement 1. Electronically. You may submit
of section 3506(c)(2)(A) of the your comments electronically to http://
Paperwork Reduction Act of 1995, the www.regulations.gov. Follow the
DEPARTMENT OF HEALTH AND Centers for Medicare & Medicaid instructions for ‘‘Comment or
HUMAN SERVICES Services (CMS) is publishing the Submission’’ or ‘‘More Search Options’’
following summary of proposed to find the information collection
Centers for Disease Control and collections for public comment.
Prevention document(s) accepting comments.
Interested persons are invited to send
comments regarding this burden 2. By regular mail. You may mail
Disease, Disability, and Injury written comments to the following
estimate or any other aspect of this
Prevention and Control Special address:
collection of information, including any
Emphasis Panel (SEP): Evaluation of
of the following subjects: (1) The CMS, Office of Strategic Operations
Breastfeeding Promotion and Support
necessity and utility of the proposed and Regulatory Affairs, Division of
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Programs for African-American


information collection for the proper Regulations Development, Attention:
Women, Potential Extramural Project
performance of the agency’s functions; Document Identifier/OMB Control
(PEP) 2008–R–25
(2) the accuracy of the estimated Number lll, Room C4–26–05, 7500
In accordance with Section 10(a)(2) of burden; (3) ways to enhance the quality, Security Boulevard, Baltimore,
the Federal Advisory Committee Act utility, and clarity of the information to Maryland 21244–1850.

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Federal Register / Vol. 73, No. 76 / Friday, April 18, 2008 / Notices 21139

Dated: April 9, 2008. Application for Food and Drug Section 314.50(i) requires that patent
Michelle Shortt, Administration Approval to Market a certification information be submitted
Director, Regulations Development Group, New Drug—(OMB Control Number in section 505(b)(2) applications for
Office of Strategic Operations and Regulatory 0910–0001—Extension) patents claiming the drug, drug product,
Affairs. Under section 505(a) of the Federal or method of use.
[FR Doc. E8–8229 Filed 4–17–08; 8:45 am] Food, Drug, and Cosmetic Act (the act) Section 314.50(j) requires that
BILLING CODE 4120–01–P (21 U.S.C. 355(a)), a new drug may not applicants that request a period of
be commercially marketed in the United marketing exclusivity submit certain
States, imported, or exported from the information with the application.
DEPARTMENT OF HEALTH AND United States, unless an approval of an Section 314.50(k) requires that an
HUMAN SERVICES application filed with FDA under archival, review, and field copy of the
section 505(b) or 505(j) of the act is application be submitted.
Food and Drug Administration effective with respect to such drug. Section 314.52 requires that any
Under the act, it is the sponsor’s notice of certification of invalidity or
[Docket No. FDA–2007–N–0321] (formerly responsibility to provide the noninfringement of a patent to each
Docket No. 2007N–0485) information needed by FDA to make a patent owner and the NDA holder be
scientific and technical determination sent by a section 505(b)(2) applicant that
Agency Information Collection whether the product is safe and effective relies on a listed drug. A 505(b)(2)
Activities; Submission for Office of for use. applicant is required to amend its
Management and Budget Review; This information collection approval application at the time notice is
Comment Request; Application for request is for all information provided to include a statement
Food and Drug Administration requirements imposed on sponsors by certifying that the required notice has
Approval to Market a New Drug the regulations under part 314 (21 CFR been provided. A 505(b)(2) applicant
part 314), who apply for approval of a also is required to amend its application
AGENCY: Food and Drug Administration, new drug application (NDA) or to document receipt of the required
HHS. abbreviated new drug application notice.
(ANDA) in order to market or to Section 314.54 sets forth the content
ACTION: Notice. continue to market a drug. requirements for applications filed
Section 314.50(a) requires that an under section 505(b)(2) of the act. (The
SUMMARY: The Food and Drug application form (Form FDA 356h) be information collection burden estimate
Administration (FDA) is announcing submitted that includes introductory for 505(b)(2) applications is included in
that a proposed collection of information about the drug as well as a table 1 of this document under the
information has been submitted to the checklist of enclosures. estimates for § 314.50 (a), (b), (c), (d), (e),
Office of Management and Budget Section 314.50(b) requires that an (f), and (k)).
(OMB) for review and clearance under index be submitted with the archival Section 314.60 sets forth reporting
the Paperwork Reduction Act of 1995. copy of the application and that it requirements for sponsors who amend
reference certain sections of the an unapproved application.
DATES: Fax written comments on the application. Section 314.65 states that the sponsor
collection of information by May 19, Section 314.50(c) requires that a must notify FDA when withdrawing an
2008. summary of the application be
unapproved application.
submitted that presents a good general
ADDRESSES: To ensure that comments on Sections 314.70 and 314.71 require
synopsis of all the technical sections
the information collection are received, that supplements be submitted to FDA
and other information in the
OMB recommends that written for certain changes to an approved
application.
comments be faxed to the Office of Section 314.50(d) requires that the application.
Information and Regulatory Affairs, NDA contain the following technical Section 314.72 requires sponsors to
OMB, Attn: FDA Desk Officer, FAX: sections about the new drug: Chemistry, report to FDA any transfer of ownership
manufacturing, and controls; of an application.
202–395–6974, or e-mailed to
nonclinical pharmacology and Section 314.80(c)(1) and (c)(2) sets
baguilar@omb.eop.gov. All comments
toxicology; human pharmacokinetics forth requirements for expedited
should be identified with the OMB
and bioavailability; microbiology; adverse drug experience postmarketing
control number 0910–0111 and
clinical data; and statistical section. reports and followup reports, as well as
Application for Food and Drug
Section 314.50(e) requires the for periodic adverse drug experience
Administration Approval to Market a
applicant to submit samples of the drug postmarketing reports (Form FDA
New Drug. Also include the FDA docket 3500A). (The burden hours for
number found in brackets in the if requested by FDA. In addition, the
archival copy of the application must §§ 314.80(c)(1) and (c)(2) are already
heading of this document. approved by OMB under OMB control
include copies of the label and all
FOR FURTHER INFORMATION CONTACT: labeling for the drug. numbers 0910–0230 and 0910–0291 and
Elizabeth Berbakos, Office of the Chief Section 314.50(f) requires that case are not included in the burden estimates
Information Officer (HFA–250), Food report forms and tabulations be in table 1 of this document.)
and Drug Administration, 5600 Fishers submitted with the archival copy. Section 314.80(i) establishes
Lane, Rockville, MD 20857, 301–827– Section 314.50(h) requires that patent recordkeeping requirements for reports
1482. information, as described under of postmarketing adverse drug
§ 314.53, be submitted with the experiences. (The burden hours for
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SUPPLEMENTARY INFORMATION: In application. (The burden hours for § 314.80(i) are already approved by
compliance with 44 U.S.C. 3507, FDA § 314.50(h) are already approved by OMB under OMB control numbers
has submitted the following proposed OMB under OMB control number 0910– 0910–0230 and 0910–0291 and are not
collection of information to OMB for 0513 and are not included in the burden included in the burden estimates in
review and clearance. estimates in table 1 of this document.) table 1 of this document.)

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