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19090 Federal Register / Vol. 70, No.

69 / Tuesday, April 12, 2005 / Notices

b. Current Budget Period Financial Public Health Analyst, Centers for notice requesting nominations for
Progress. Disease Control and Prevention, individuals to serve on the Advisory
c. New Budget Period Program National Center for HIV, STD, and TB Board on the Demonstration of a
Proposed Activity Objectives. Prevention, Division of HIV/AIDS Bundled Case-Mix Adjusted Payment
d. Budget. Prevention, Capacity Building Branch, System for End-Stage Renal Disease
e. Measures of effectiveness. 1600 Clifton Road, Mailstop E–40, (ESRD) Services. The June 2, 2004
f. Additional requested information, Atlanta, GA 30333, Telephone: 404– notice also announced the
including (1) data related to 639–2918. E-mail address: establishment of the Advisory Board
performance target goals; (2) data on DHAPCBAPT@CDC.GOV. and the signing by the Secretary on May
progress toward achieving objectives; (3) For financial, grants management, or 11, 2004 of the charter establishing the
an inventory of total individual capacity budget assistance, contact: Roslyn Advisory Board. On January 28, 2005,
building assistance and proactive Curington, Grants Management we published a Federal Register notice
training for the reporting period; and (4) Specialist, Centers for Disease Control (70 FR 4132) announcing the
data related to the quality assurance and Prevention, Procurement and appointment of eleven individuals to
system. Grants Office, 2920 Brandywine Road, serve as members of the Advisory Board
2. Second trimester interim progress Room 3000, Atlanta, Georgia 30341– on the Demonstration of a Bundled
report shall be due 30 days after the 4146. Telephone: 770–488–2767, E-mail Case-Mix Adjusted Payment System for
completion of the first eight (8) months address: ESRD Services, including one
of the project period. This second individual to serve as co-chairperson,
trimester progress report will serve as VIII. Other Information
and one additional co-chairperson, who
your non-competing continuation This and other CDC funding is employed by CMS. The first public
application for the next funding cycle. opportunity announcements can be meeting of the Advisory Board was held
(See Continuing Application found on the CDC Web site, Internet on February 16, 2005. The second
Requirements provided by Procurement address: Click on public meeting of the Advisory Board
and Grants Office.) This report must ‘‘Funding’’ then ‘‘Grants and scheduled for April 13, 2005 has been
include elements a–f, as listed in the Cooperative Agreements.’’ cancelled.
first trimester report, and be completed Dated: April 6, 2005. Authority: 5 U.S.C. App. 2, section 10(a).
during this time period (months 5–8).
William P. Nichols, (Catalog of Federal Domestic Assistance
The report should also include the
Director, Procurement and Grants Office, Program No. 93.774, Medicare—
Centers for Disease Control and Prevention. Supplementary Medical Insurance Program)
a. Base line and actual level of core
performance indicators. [FR Doc. 05–7286 Filed 4–11–05; 8:45 am] Dated: April 7, 2005.
b. Specific guidance, which will be BILLING CODE 4163–18–P Mark B. McClellan,
provided by the CDC three months prior Administrator, Centers for Medicare &
to the due date. Medicaid Services.
3. The third trimester progress report DEPARTMENT OF HEALTH AND [FR Doc. 05–7408 Filed 4–8–05; 1:51 pm]
shall be due 30 days after the end of the HUMAN SERVICES
budget period. This report must include
Centers for Medicare & Medicaid
elements a–f as listed in the first
trimester report, elements a–b as listed DEPARTMENT OF HEALTH AND
in the second trimester report, and [CMS–5033–N6] HUMAN SERVICES
completed during this time period
(months 9–12). Medicare Program; Cancellation of the Food and Drug Administration
4. Financial status report is due no April 13, 2005 Advisory Board Meeting
more than 90 days after the end of the on the Demonstration of a Bundled Cooperative Agreement to Support the
budget period. Case-Mix Adjusted Payment System World Health Organization
5. Final financial and performance for End-Stage Renal Disease Services International Programme on Chemical
reports are due no more than 90 days Safety
AGENCY: Centers for Medicare &
after the end of the project period. Medicaid Services (CMS), HHS. AGENCY: Food and Drug Administration,
These reports must be mailed to the HHS.
ACTION: Cancellation of meeting.
Grants Management or Contract ACTION: Notice.
Specialist listed in the ‘‘Agency SUMMARY: This notice cancels the April
Contacts’’ section of this announcement. 13, 2005 Advisory Board Meeting on the I. Funding Opportunity Description
VII. Agency Contacts Demonstration of a Bundled Case-Mix
The Food and Drug Administration
Adjusted Payment System for End-Stage
We encourage inquiries concerning (FDA) is announcing its intent to accept
Renal Disease (ESRD) Services. We
this announcement. and consider a single source application
published the meeting notice in the
For Pre-application Technical for the award of a cooperative agreement
Federal Register on March 25, 2005 (70
Consultation: Send questions regarding to the World Health Organization
FR 15343).
this application to (WHO) to support the International
DATES: Effective Date: The notice Programme on Chemical Safety (IPCS).
receive a response within 24–48 hours. announcing the cancellation of the FDA anticipates providing $90,000
For general questions, contact: meeting is effective April 12, 2005. (direct and indirect costs) in fiscal year
Technical Information Management FOR FURTHER INFORMATION CONTACT: 2005 in support of this project. Subject
Section, CDC Procurement and Grants Pamela Kelly by e-mail at to the availability of Federal funds and
Office, 2920 Brandywine Road, Atlanta, or successful performance, 2 additional
GA 30341. Telephone: 770–488–2700. telephone at (410) 786–2461. years of support up to $90,000 per year
For program technical assistance, SUPPLEMENTARY INFORMATION: On June 2, (direct and indirect costs) will be
contact: Gerlinda Gallegos Somerville, 2004, we published a Federal Register available. FDA will support the research

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Federal Register / Vol. 70, No. 69 / Tuesday, April 12, 2005 / Notices 19091

covered by this notice under the III. Application and Submission (HFG–3), 15800 Crabbs Branch Way,
authority of section 301 of the Public For further information or a copy of Rockville, MD 20855. Send one self-
Health Service (PHS) Act (42 U.S.C. the complete Request for Applications addressed adhesive label to assist that
241). FDA’s research program is (RFA) contact Cynthia Polit, Grants office in processing your requests.
described in the Catalog of Federal Management Specialist, Division of Submit written comments concerning
Domestic Assistance No. 93.103. Before Contracts and Grants Management the guidance to the Division of Dockets
entering into cooperative agreements, (HFA–500), Food and Drug Management (HFA–305), Food and Drug
FDA carefully considers the benefits Administration, 5600 Fishers Lane, Administration, 5630 Fishers Lane, rm.
such agreements will provide to the Rockville, MD 20857, 301–827–7180, e- 1061, Rockville, MD 20852. Submit
public. mail: or electronic comments to http://
The cooperative agreement ensures This RFA can also be See
FDA’s participation and leadership in viewed on under ‘‘Grant the SUPPLEMENTARY INFORMATION section
important international risk assessment Find.’’ A copy of the complete RFA can for electronic access to the guidance
and standard setting activities for food also be viewed on FDA’s Center for document.
ingredients, contaminants, and Food Safety and Applied Nutrition Web FOR FURTHER INFORMATION CONTACT:
veterinary drug residues. The site at Suzanne O’Shea, Office of Combination
development of such international list.html. Products (HFG–3), Food and Drug
standards provides the public with Administration, 15800 Crabbs Branch
greater assurance of the quality and Dated: April 5, 2005.
Jeffrey Shuren,
Way, Rockville, MD 20855, 301–427–
safety of food sold in the United States. 1934, FAX: 301–427–1935.
Assistant Commissioner for Policy.
[FR Doc. 05–7288 Filed 4–11–05; 8:45 am]
Competition is limited to the WHO/ BILLING CODE 4160–01–S I. Background
IPCS because it is the parent FDA is announcing the availability of
organization of the Joint Food and a guidance for industry and FDA staff
Agriculture Organization (FAO)/WHO DEPARTMENT OF HEALTH AND
entitled ‘‘Submission and Resolution of
Expert Committee on Food Additives HUMAN SERVICES
Formal Disputes Regarding the
(JECFA), which provides scientific Timeliness of Premarket Review of a
advice to the Codex Alimentarius Food and Drug Administration
Combination Product.’’ In the Federal
Commission (CAC). The international [Docket No. 2004D–0182] Register of May 4, 2004 (69 FR 24653),
food standards established by the CAC FDA issued a notice of availability of a
are recognized by the World Trade Guidance for Industry and Food and draft guidance document covering the
Organization (WTO) as necessary to Drug Administration Staff; Submission same topic. The draft guidance
protect public health and presumed to and Resolution of Formal Disputes document was entitled ‘‘Combination
be consistent with the Sanitary and Regarding the Timeliness of Premarket Products, Timeliness of Premarket
Phytosanitary (SPS) Agreement of the Review of a Combination Product; Reviews, Dispute Resolution Guidance.’’
General Agreement on Tariffs and Trade Availability MDUFMA delegated to OCP
(GATT). These programs under the IPCS responsibility for resolving disputes
are the only such programs in existence, AGENCY: Food and Drug Administration,
HHS. about the timeliness of reviews of
and make the IPCS unique as a premarket applications covering
participant in international standard ACTION: Notice.
combination products. This guidance
setting for food ingredients, document provides information on how
SUMMARY: The Food and Drug
contaminants, and veterinary drug an applicant submitting an application
Administration (FDA) is announcing the
residues. Awarding this cooperative covering a combination product can
availability of a guidance for industry
agreement will help ensure that the risk submit a request that OCP resolve such
and FDA staff entitled ‘‘Submission and
assessments provided by the JECFA to a dispute.
Resolution of Formal Disputes
the CAC are science-based, enhance the This guidance is being issued
Regarding the Timeliness of Premarket
safety of food sold in the United States, consistent with FDA’s good guidance
Review of a Combination Product.’’ The
and enhance the safety of food additives practices regulation (21 CFR 10.115).
Medical Device User Fee and
and veterinary drug residues in The guidance represents the agency’s
Modernization Act of 2002 (MDUFMA)
imported food. current thinking on how to present to
delegates to the Office of Combination
As of October 1, 2003, applicants are Products (OCP) responsibility for OCP disputes pertaining to the
required to have a Dun and Bradstreet resolving disputes about the timeliness timeliness of reviews of combination
Number (DUNS) number to apply for a of premarket review of combination products. It does not create or confer
grant or cooperative agreement from the products. This guidance document any rights for or on any person and does
Federal Government. The DUNS provides information about presenting not operate to bind FDA or the public.
number is a 9-digit identification requests for resolution of disputes about An alternative approach may be used if
number, which uniquely identifies the timeliness of premarket review of such approach satisfies the
business entities. Obtaining a DUNS combination products. requirements of the applicable statute
number is easy and there is no charge. and regulations.
DATES: Submit written or electronic
To obtain a DUNS number, foreign
applicants should go to http:// comments on agency guidances at any II. Comments, 4th time. General comments on agency Interested persons may submit to the
paragraph. (FDA has verified the Web guidance documents are welcome at any Division of Dockets Management (see
site address, but FDA is not responsible time. ADDRESSES), written or electronic
for any subsequent changes to the Web ADDRESSES: Submit written requests for comments on the guidance at any time.
site after this document publishes in the single copies of this guidance document Submit two paper copies of any mailed
Federal Register.) to the Office of Combination Products comments, except that individuals may

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