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22956 Federal Register / Vol. 73, No.

82 / Monday, April 28, 2008 / Notices

Service Act (the PHS Act) (42 U.S.C. FDA to evaluate the safety and the estimated burden of 2,000 hours
262). Information about the safety or effectiveness of in vivo because safety and effectiveness
effectiveness of a diagnostic radiopharmaceuticals still needs to be information is already required by
radiopharmaceutical enables FDA to reported. § 314.50 (collection of information
properly evaluate the safety and Based on the number of submissions approved by OMB under OMB control
effectiveness profiles of a new (that is, human drug applications and/ number 0910–0001). In fact,
diagnostic radiopharmaceutical or a or new indication supplements for clarification in these regulations of
new indication for use of an approved diagnostic radiopharmaceuticals) that FDA’s standards for evaluation of
diagnostic radiopharmaceutical. FDA receives, the agency estimates that diagnostic radiopharmaceuticals is
The rule clarifies existing FDA it will receive approximately two intended to streamline overall
requirements for approval and submissions annually from two information collection burdens,
evaluation of drug and biological applicants. The hours per response particularly for diagnostic
products already in place under the refers to the estimated number of hours radiopharmaceuticals that may have
authorities of the act and the PHS Act. that an applicant would spend well established, low risk safety
The information, which is usually preparing the information required by
profiles, by enabling manufacturers to
submitted as part of a new drug the regulations. Based on FDA’s
tailor information submissions and
application or biologics license experience, the agency estimates the
avoid unnecessary clinical studies.
application or as a supplement to an time needed to prepare a complete
Table 1 of this document contains
approved application, typically application for a diagnostic
includes, but is not limited to, radiopharmaceutical to be estimates of the annual reporting burden
nonclinical and clinical data on the approximately 10,000 hours, roughly for the preparation of the safety and
pharmacology, toxicology, adverse one-fifth of which, or 2,000 hours, is effectiveness sections of an application
events, radiation safety assessments, estimated to be spent preparing the that are imposed by existing regulations.
and chemistry, manufacturing, and portions of the application that would This estimate does not include the
controls. The content and format of an be affected by these regulations. The actual time needed to conduct studies
application for approval of a new drug regulation does not impose any and trials or other research from which
are set forth in § 314.50 (21 CFR 314.50). additional reporting burden for safety the reported information is obtained.
Under 21 CFR part 315, information and effectiveness information on FDA estimates the burden of this
required under the act and needed by diagnostic radiopharmaceuticals beyond collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1


No. of Annual Frequency per Total Annual Hours per
21 CFR Section Total Hours
Respondents Response Responses Response

315.4, 315.5, and 315.6 2 1 2 2,000 4,000

Total 4,000

Please note that on January 15, 2008, DEPARTMENT OF HEALTH AND of Federal Domestic Assistance No.
the FDA Division of Dockets HUMAN SERVICES 93.103 under RFA Number: RFA–FD–
Management Web site transitioned to 08–002. A copy of the complete RFA
the Federal Dockets Management Food and Drug Administration can also be viewed on CFSAN’s Web
System (FDMS). FDMS is a site (http://www.cfsan.fda.gov) and on
Cooperative Agreement to Support the CVM’s Web site (http://www.fda.gov/
Government-wide, electronic docket
World Health Organization cvm).
management system. Electronic
International Programme on Chemical
comments or submissions will be This RFA will strengthen and allow
Safety
accepted by FDA only through FDMS at WHO to continue their work in
http://www.regulations.gov. AGENCY: Food and Drug Administration, important international risk assessment
HHS. and standard setting activities for food
Dated: April 18, 2008.
ingredients, contaminants, and
Jeffrey Shuren, ACTION: Notice.
veterinary drug residues in food. WHO/
Associate Commissioner for Policy and IPCS is an umbrella organization that
Planning. I. Funding Opportunity Description
provides for timely international
[FR Doc. E8–9159 Filed 4–25–08; 8:45 am] The Food and Drug Administration collaboration on multinational
BILLING CODE 4160–01–S (FDA) is announcing its intention to cooperative activities. Various programs
receive and consider a single source under the WHO/IPCS, such as the Joint
application for the award of a Food and Agriculture (FAO)/WHO
cooperative agreement (U01), a new Expert Committee on Food Additives
Sole Source, Competitive Continuation (JECFA), significantly contribute to
in fiscal year 2008 to the World Health internationally-recognized, science-
Organization (WHO) International based risk assessments of food
Programme on Chemical Safety (IPCS). additives, contaminants, and residues of
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This Request for Applications (RFA) is veterinary drugs in foods. The Codex
supported by the Center for Food Safety Alimentarius Commission (CAC) relies
and Applied Nutrition (CFSAN) and the on JECFA’s scientific advice when
Center for Veterinary Medicine (CVM). establishing international standards for
This program is described in the Catalog foods. The WHO/IPCS also supports

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Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices 22957

FAO/WHO Expert Consultations on risk III. Eligibility Information Budget for Entire Proposed Period of
assessments for emerging or cross- Support: Biographical Sketch Format
Eligible Institutions
cutting issues (e.g., non-dioxin-like Page; Resources Format Page; Checklist
polychlorinated biphenyls (PCBs), Competition is limited to the WHO/ Form Page: Personal Data Form Page;
allergenicity of foods derived from IPCS because, as the parent organization Other Support Format Page; Personnel
biotechnology, risk-benefit assessment of the JECFA, it is solely responsible for Report Format Page.
of the use of active chlorine species in providing scientific advice, including
risk assessments, to the CAC on matters B. Sending an Application to FDA
food processing). The evaluations that
are produced by these Expert related to food additives, contaminants, The application must be prepared
Consultations provide a sound scientific and residues of veterinary drugs in food. using the forms found in the PHS 398
basis for Codex’s standard-setting Thus, the programs under the IPCS are instructions for preparing a research
activities that contribute to improved unique. It is essential that the WHO/ grant application. Applications will be
public health and food safety IPCS be able to provide science-based accepted in hard copy or electronically
worldwide. risk assessments that are of the highest at http://www.grants.gov. A signed hard
The following activities are to be integrity, as these assessments form the copy original application and three
supported by this cooperative basis of international standards that signed photocopies should be sent to:
agreement: both protect public health and promote Food and Drug Administration/
1. Schedule, plan, and conduct fair trade practices. Awarding this OAGS/GAAT/Gladys M. Bohler, 5630
appropriate work groups, consultations, cooperative agreement to the WHO/IPCS Fishers Lane, rm. 2105, HFA–500,
and committee meetings, which have will ensure that JECFA’s risk Rockville, MD 20857 (U.S. Postal
emphasis on, but are not limited to, food assessments are science-based, will Service Express or regular mail).
additives, contaminants, and residues of enhance the safe use of food additives, FDA will also accept the application
veterinary drugs in food. will ensure that residues of veterinary for this program electronically via
2. Identify advisers, and prepare drugs in imported foods are safe, and http://www.grants.gov. The applicant is
written working papers summarizing will help to ensure that food sold in the encouraged to apply electronically by
the data on substances under United States is safe. visiting the Web site http://
consideration. IV. Application and Submission www.grants.gov and following
3. Prepare written working papers and Information instructions under ‘‘Apply for Grants.’’
technical documents for the JECFA, and The required application, SF 424 (R&R)
for the FAO/WHO Expert Consultations The PHS 398 application instructions can be completed and submitted online.
related to food additives, contaminants, are available at http://grants.nih.gov/ The package should be labeled,
and residues of veterinary drugs in food. grants/funding/phs398/phs398.html in ‘‘Response to RFA FD–08–002.’’ If you
an interactive format. Applicants must experience technical difficulties with
II. Award Information use the currently approved version of your online submission you should
A. Mechanism of Support the PHS 398. For further assistance contact Gladys M. Bohler by telephone
contact Grants Info at 301–435–0714, e- at 301–827–7168 or by e-mail at
This funding opportunity will use a mail: GrantsInfo@nih.gov.
cooperative agreement award gladys.melendez-bohler@fda.hhs.gov
Telecommunications for the hearing
mechanism. In the cooperative Information about submitting an
impaired: TTY 301–451–0088.
agreement mechanism, the Project application electronically can be found
Director/Principal Investigator (PD/PI) A. Content and Form of Application on the http://www.grants.gov Web site.
retains the primary responsibility and Submission PHS 398 Research Plan Component
dominant role for planning, directing, Applications must be prepared using Sections via Grants.gov
and executing the proposed project, the most current PHS 398 research grant Items 2 through 5 of the PHS 398
with NIH staff being substantially application instructions and forms. Research Plan component are limited to
involved as a partner with the Principal Applications must have a Dun & 25 pages. While each section of the
Investigator. Bradstreet Data Universal Numbering Research Plan component needs to be
Receipt Date: Within 45 days after the System (DUNS) number as the universal uploaded separately as a PDF
publication of this announcement in the identifier when applying for Federal attachment, applicants are encouraged
Federal Register. grants or cooperative agreements. The to construct the Research Plan
DUNS number can be obtained by component as a single document,
B. Funds Available separating sections into distinct PDF
calling 866–705–5711 or through the
The estimated amount of funds Web site at http://www.dnb.com/us/. attachments just before uploading the
available for support of this cooperative The DUNS number should be entered files. This approach will enable
agreement is $120,000 (direct and on line 11 of the face page of the PHS applicants to better monitor formatting
indirect costs) for fiscal year 2008. It is 398 form. requirements such as page limits. All
anticipated that an additional 4 years of The title and number of this funding attachments must be provided to FDA in
support will be available at $90,000 per opportunity must be typed on lines 1 PDF format, filenames must be included
year, depending on annual and 2 of the face page of the application with no spaces or special characters,
appropriations and successful form and the YES box must be checked. and a pdf extension must be used.
performance. Required 398 Application In order to apply electronically the
This award will be funded based on Components must be submitted in Non applicant must have a DUNS number
the quality of the application received Modular format as follows: and register in the central contractor
and is subject to the availability of Form Page 1: Face Page; Form Page 2: registration (CCR) database.
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Federal funds to support the project. In Description, Performance Sites, Key


C. Intergovernmental Review
addition, if a cooperative agreement is Personnel, Other Significant
awarded, the grantee will be informed of Contributors; Form Page 3: Table of This initiative is not subject to
any additional documentation that Contents; Form Page 4: Detailed Budget intergovernmental review under the
should be submitted to the FDA. for Initial Budget Period: Form Page 5: terms of Executive Order 12372.

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22958 Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices

D. Other Submission Requirements and e-mail: gladys.melendez- guidance before it begins work on the
Information bohler@fda.hhs.gov. final version of the guidance, submit
Several additional separate actions are Dated: April 22, 2008. written or electronic comments on the
required before an applicant institution/ Jeffrey Shuren,
draft guidance by July 28, 2008.
organization can submit an application. ADDRESSES: Submit written requests for
Associate Commissioner for Policy and
Organizational DUNS—As of October Planning. single copies of the draft guidance to the
1, 2003, applicants are required to have [FR Doc. E8–9251 Filed 4–25–08; 8:45 am]
Office of Communication, Training, and
a DUNS number to apply for a grant or Manufacturers Assistance (HFM–40),
BILLING CODE 4160–01–S
cooperative agreement from the Federal Center for Biologics Evaluation and
Government. The DUNS number is a Research (CBER), Food and Drug
nine-digit identification number, which DEPARTMENT OF HEALTH AND Administration, 1401 Rockville Pike,
uniquely identifies business entities. HUMAN SERVICES suite 200N, Rockville, MD 20852–1448.
Obtaining a DUNS number is easy and Send one self-addressed adhesive label
there is no charge. To obtain a DUNS Food and Drug Administration to assist the office in processing your
number applicants should go to http:// requests. The draft guidance may also be
[Docket No. FDA–2008–D–0233] obtained by mail by calling CBER at 1–
www.grants.gov/RequestaDUNS.
Central Contractor Registration— Draft Guidance for Industry: Use of 800–835–4709 or 301–827–1800. See
Applicants must register with the CCR Nucleic Acid Tests to Reduce the Risk the SUPPLEMENTARY INFORMATION section
database. This database is a government- of Transmission of West Nile Virus for electronic access to the draft
wide warehouse of commercial and from Donors of Whole Blood and guidance document.
financial information for all Submit written comments on the draft
Blood Components Intended for
organizations conducting business with guidance to the Division of Dockets
Transfusion and Donors of Human
the Federal Government. The preferred Management (HFA–305), Food and Drug
Cells, Tissues, and Cellular and
method for completing a registration is Administration, 5630 Fishers Lane, rm.
Tissue-Based Products (HCT/Ps);
at http://www.ccr.gov. This Web site 1061, Rockville, MD 20852. Submit
Availability
provides a CCR handbook with detailed electronic comments to http://
information on data you will need prior AGENCY: Food and Drug Administration, www.regulations.gov.
to beginning the online preregistration HHS. FOR FURTHER INFORMATION CONTACT:
as well as steps to walk you through the ACTION: Notice. Tami Belouin, Center for Biologics
registration process. You must have a Evaluation and Research (HFM–17),
DUNS number to begin your SUMMARY: The Food and Drug Food and Drug Administration, 1401
registration. For foreign entities the Web Administration (FDA) is announcing the Rockville Pike, suite 200N, Rockville,
site is http://www.grants.gov/ availability of a draft document entitled MD 20852–1448, 301–827–6210.
RequestaDUNS.gov. In order to access ‘‘Guidance for Industry: Use of Nucleic SUPPLEMENTARY INFORMATION:
Grants.gov an applicant will be required Acid Tests to Reduce the Risk of
to register with the Credential Provider. Transmission of West Nile Virus from I. Background
Information about this is available at Donors of Whole Blood and Blood FDA is announcing the availability of
https://apply.grants.gov/OrcRegister. Components Intended for Transfusion a draft document entitled ‘‘Guidance for
A copy of the complete RFA can also and Donors of Human Cells, Tissues, Industry: Use of Nucleic Acid Tests to
be viewed on FDA’s Center for Food and Cellular and Tissue-Based Products Reduce the Risk of Transmission of
Safety and Applied Nutrition Web site (HCT/Ps)’’ dated April 2008. This draft West Nile Virus from Donors of Whole
at http://www.cfsan.fda.gov/list.html. guidance is intended for establishments Blood and Blood Components Intended
Foreign Applications (Non-domestic that collect Whole Blood and blood for Transfusion and Donors of Human
(non-U.S.) Entity) components intended for transfusion Cells, Tissues, and Cellular and Tissue-
• Indicate how the proposed project and establishments that make donor Based Products (HCT/Ps)’’ dated April
has specific relevance to the mission eligibility determinations for donors of 2008. This draft guidance is intended
and objectives of FDA and has the human cells, tissues, and cellular and for establishments that collect Whole
potential for significantly advancing tissue-based products (HCT/Ps). The Blood and blood components intended
sciences in the United States. document provides recommendations for transfusion and establishments that
• Research grant applications from for testing of donations of Whole Blood make donor eligibility determinations
foreign or international organizations and blood components and HCT/P for donors of human cells, tissues, and
may not be funded unless approved by donor specimens for West Nile Virus cellular and tissue-based products HCT/
the National Cancer Institute National (WNV) using an FDA-licensed donor Ps. The document provides
Advisory Board. screening assay. FDA believes that the recommendations for testing of
use of a licensed nucleic acid test (NAT) donations of Whole Blood and blood
IV. Agency Contacts
will reduce the risk of transmission of components and HCT/P donor
A. Scientific/Research Contacts WNV, and therefore recommend use of specimens for WNV using an FDA-
For issues regarding the programmatic a licensed NAT to screen donors of licensed donor screening assay. FDA
aspects of this document, contact Susan Whole Blood and blood components believes that the use of a licensed NAT
E. Carberry at 301–436–1269 or by e- intended for transfusion and for testing will reduce the risk of transmission of
mail: susan.carberry@fda.hhs.gov. donors of HCT/Ps for infection with WNV, and therefore recommend use of
WNV. FDA recommends the use of a licensed NAT to screen donors of
B. Financial or Grants Management licensed NAT testing for WNV within 6 Whole Blood and blood components
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Contacts months after a final guidance is issued. intended for transfusion and for testing
For issues regarding the DATES: Although you can comment on donors of HCT/Ps for infection with
administrative and financial any guidance at any time (see 21 CFR WNV. FDA recommends the use of
management aspects, contact Gladys 10.115(g)(5)), to ensure that the agency licensed NAT testing for WNV within 6
Melendez-Bohler at 301–827–7168 or by considers your comment on this draft months after a final guidance is issued.

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