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Federal Register / Vol. 70, No.

115 / Thursday, June 16, 2005 / Notices 35103


No. of Annual responses Total annual Hours per
21 CFR section respondents per respondent responses response Total hours

99.201(b) 5 1 10 0.5 5

99.201(c) 5 1 10 0.5 5

99.203(a) 1 1 1 10 10

99.203(b) 1 1 1 10 10

99.203(c) 1 1 2 0.5 1

99.205(b) 1 1 1 82 82

99.501(b)(1) 5 3 20 8 160

99.501(b)(2) 5 1 20 1 20

99.501(b)(3) 5 1 20 20 400

99.501(b)(4) 1 1 1 2 2

99.501(b)(5) 1 1 1 41 41

Total Hours 2,018

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


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

99.501(a)(1) 5 1 8 10 80

99.501(a)(2) 5 1 8 1 8

99.501(c) 5 1 8 1 8

Total Hours 96
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated burden associated with ACTION: Notice. policy is to participate with other
the information collection requirements organizations to support meetings where
for these regulations is 2,114 hours. I. Funding Opportunity Description practicable, rather than provide sole
Dated: June 9, 2005. support. In view of the diversity of
The Food and Drug Administration interests among the various FDA
Jeffrey Shuren, (FDA) is revising the Request for centers/offices, and in order to provide
Assistant Commissioner for Policy. Applications (RFA) published in the maximum flexibility, FDA will not set
[FR Doc. 05–11863 Filed 6–15–05; 8:45 am] Federal Register of June 6, 2002 (67 FR rigid requirements concerning the type
BILLING CODE 4160–01–S 39013). This revised RFA supercedes of scientific meetings to be supported so
the June 6, 2002, document in its long as they are within the agency’s
entirety. FDA’s authority to enter into mission.
DEPARTMENT OF HEALTH AND grants and cooperative agreements is
HUMAN SERVICES detailed under title XVII of the Public II. Award Information
Health Service Act (42 U.S.C. 300u–1) FDA views the partial support of
Food and Drug Administration or the Radiation Control for Health and scientific conferences as an ongoing
Safety Act of 1968 (Pub. L. 90–602) (21 program and may award a limited
Support for Small Scientific
U.S.C. 360hh-ss, formerly 42 U.S.C. number of grants each fiscal year. These
Conference Grants; Availability of
263b-n). awards are subject to availability of
Grants; Request for Applications;
Announcement Type: Modification of 1. Background funds and range from $1,000 to $25,000
Notice; Funding Opportunity Number: in direct costs only per conference. This
FDA recognizes the value of partially announcement is intended to be a
HHS–GRANTS–110204–001; Catalog of
supporting scientific meetings and ‘‘Standing Program Announcement’’
Federal Domestic Assistance Number:
conferences designed to coordinate, and will be modified in the event of
exchange, and disseminate information required changes to the program.
AGENCY: Food and Drug Administration, when the objectives are clearly within Support for this program will be in
HHS. the scope of the agency’s mission. FDA’s the form of a grant. These grants will be

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35104 Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices

subject to all policies and requirements after the document publishes in the 6. Physical facilities required for the
that govern the support for small Federal Register). The applicant must conduct of the meeting (e.g.,
scientific conference grant programs of register with the Credential Provider for simultaneous translation facilities);
FDA, including the provisions of 42 Information about this 7. Justification of the conference,
CFR part 52, and 45 CFR parts 74 and requirement is available at http:// including the problems it intends to
92, as applicable. The length of support clarify and any developments it may
will last for up to 1 year from date of (FDA has verified the Web site address, stimulate;
award. but FDA is not responsible for 8. Brief biographical sketches of
subsequent changes to the Web site after individuals responsible for planning the
III. Eligibility the document publishes in the Federal conference and indication of adequate
1. Eligible Applicants Register). If applicants cannot submit support staff;
applications through the electronic 9. Information about all related
Conference grant support is available conferences held by the applicant on
to any public or private nonprofit entity process, application forms are available
from, and completed applications this subject during the last 3 years (if
including State and local units of known);
government, scientific and professional should be submitted to, Tya Marks,
Division of Contracts and Grants 10. Details of proposed per diem/
societies, faith-based organizations, and subsistence rates, transportation,
for-profit entities. For-profit entities Management (HFA–500), Food and Drug
Administration, 5600 Fishers Lane, printing, supplies, and facility rental
must commit to excluding fees or profit costs;
Rockville, MD 20857, 301–827–7179, e-
from the conference in their request for 11. The budget for the entire
mail: Applications
support. conference, budget items requested from
In the case of an international hand-carried or commercially delivered
should be addressed to 5630 Fishers FDA, budget items supported by other
conference held in the United States or sources, and a list, including amounts,
Canada, the U.S. component of an Lane (HFA–500), rm. 2139, Rockville,
MD 20857. Application instructions of all other anticipated support; and
established international scientific or 12. The necessary checklist and
professional society is the eligible (PHS 5161–1 revised 7/00) and
application forms (SF–424 revised 9/03) assurance pages provided in each
applicant. In exceptional cases, where application package.
are available via the Internet at: http://
there is no U.S. component, a grant to Some examples of allowable costs
support a specific segment of an include the following items: (1) Salaries
international conference may be 2. Content and Form of Applications in proportion to the time or effort spent
awarded directly to a foreign institution directly on the conference, (2) rental of
A. Submission
provided that the following conditions necessary equipment, (3) travel and per
are met: (1) Grants to foreign institutions If submission is electronic, the diem, (4) supplies needed to conduct
or international organizations are not application package is posted under the the meeting, (5) conference services, (6)
prohibited under the governing ‘‘APPLY’’ section of this announcement publication costs, (7) registration fees,
legislation and (2) approval of the under The required (8) working meals where business is
Department of Health and Human application forms are listed under transacted, and (9) speaker fees.
Services (HHS) agency head or his or ‘‘Mandatory Documents.’’ They can be Some examples of nonallowable costs
her designee is obtained in each case. completed and submitted online. include the following items: (1)
An individual is not eligible to If applicants are not submitting Purchase of equipment; (2)
receive grant funds in support of a electronically, an original and two transportation costs exceeding coach
conference. As provided in 2 U.S.C. copies of the completed grant class fares; (3) visas; (4) passports; (5)
1611, organizations described in section application form SF–424 (revised 9/03) entertainment; (6) tips; (7) bar charges;
501(c)(4) of the Internal Revenue Code should be delivered to the address listed (8) personal telephone calls; (9) laundry
that engage in lobbying are not eligible in Addresses to Request Application in
charges; (10) travel or expenses other
to receive Federal funds constituting section IV of this document. The outside
than local mileage for local participants;
grant awards. of the package should clearly state
(11) organization dues; (12) honoraria or
‘‘Request for Conference Grant’’ and
2. Cost Sharing or Matching other payments for the purpose of
must be received by the appropriate
conferring distinction or communicating
See section IV.2.B.11 of this submission date (see Submission Dates
respect, esteem, or admiration; (13)
document. and Times in section IV of this
patient care; (14) alterations or
IV. Application and Submission renovations; and (15) indirect costs.
B. Content Grant funds may not be used to
1. Addresses to Request Applications provide general support for
Applications must include the
FDA is accepting new applications for following information: international scientific conferences held
this program electronically via 1. Title that has the term scientific outside the United States or Canada. Applicants are strongly ‘‘conference,’’ ‘‘council,’’ ‘‘workshop,’’ Grant funds may be awarded to a U.S.
encouraged to apply electronically by or other similar description to assist in component of an international
visiting the Web site http:// the identification of the request; organization to provide limited support and following the 2. Location of the conference; for specific segments of an international
instructions under ‘‘APPLY.’’ The 3. Expected number of registrants and conference held outside the United
applicant must register in the Central type of audience expected, along with States of Canada if the conference is
Contractor Registration (CCR) database speaker credentials; compatible with FDA’s mission. An
in order to be able to submit the 4. Dates of conference (inclusive). example of such support would be a
application. Information about CCR is Each application must address only one selected symposium, panel, or
available at specific conference; workshop within the conference,
CCRRegister. (FDA has verified the Web 5. Conference format and projected including the cost of planning and the
site address, but FDA is not responsible agenda, including list of principal areas cost of travel for U.S. participants for
for subsequent changes to the Web site or topics to be addressed; the specified segment of the scientific

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Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices 35105

conference. Any Public Health Service U.S. Postal Service does not uniformly section IV of this document), (3) if it is
(PHS) foreign travel restrictions that are provide dated postmarks. Before relying incomplete or if it is missing any of the
in effect at the time of the award must on this method, applicants should check elements under Content and Form of
be followed, including but not limited with their local post office. Application in section IV of this
to, limitations or restrictions on 4. Intergovernmental Review
document, (4) if it is illegible, (5) if the
countries to which travel will be proposed conference is not within
supported, and budgetary or other The regulations issued under FDA’s mission, (6) if the material
limitations on availability of funds for Executive Order 12372 may also apply presented is insufficient to determine an
foreign travel. to this program and are implemented adequate review, and/or (7) if it exceeds
through HHS regulations under 45 CFR the recommended threshold amount
C. Letter of Intent part 100. Executive Order 12372 sets up reflected in the RFA.
A letter of intent is not mandatory. a system for State and local government
However, applicants may submit a letter review of applications for Federal 2. Review and Selection Process
of intent to the contact (see Addressees financial assistance. Applicants (other Responsive applications will be
to Request Applications in section IV of than federally recognized Indian tribal reviewed and evaluated for their
this document) at least 30 days prior to governments) should contact the State’s scientific and technical merit by an ad
the application receipt date. Potential Single Point of Contact (SPOC) as early hoc review panel composed of experts
applicants are also encouraged to talk to as possible to alert them to the in the field using the following criteria:
the contact to determine if the proposed prospective application(s) and to receive a. The content/subject matter and how
scientific conference is clearly any necessary instructions on the State’s current and appropriate it is for FDA’s
consistent with FDA’s interest, mission, review processes. The names and mission;
and priorities. Potential applicants may addresses of SPOCs are listed on the b. The conference plan and how
fax letters of intent to: 301–827–7101 or Office of Management and Budget’s thorough, reasonable, and appropriate it
e-mail: (OMB’s) Web site at http:// is for the intended audience; c. The experience, training, and
3. Submission Dates and Times spoc.html. (FDA has verified the Web competence of the principal
Applications will be received and site address, but FDA is not responsible investigator/director and support staff;
reviewed quarterly during each fiscal for subsequent changes to the Web site d. The adequacy of the facilities;
year. The receipt dates are in direct after the document publishes in the e. The reasonableness of the proposed
relation to the conference date and can Federal Register). The SPOC should budget give the total conference plan,
be seen in table 1 of this document. send any State review process program, speakers, travel, and facilities;
recommendations to FDA’s and
TABLE 1.—KEY RECEIPT DATES administrative contact (see section IV of
f. Previous experience of the
this document). The due date for the
organization/principal investigator.
Earliest Beginning State process recommendation is no
Receipt Date
Conference Date later than 60 days after the deadline VI. Award Administration Information
date for the receipt of applications. FDA
December 15 October 15 1. Award Notices
does not guarantee to accommodate or
explain SPOC comments that are Successful applicants will be notified
March 15 January 15
received after the 60-day cutoff. via Notice of Grant Award signed by the
June 15 April 15 Chief Grants Management Officer, FDA.
5. Funding Restrictions
September 15 July 15 See section IV.2.B of this document. 2. Administrative and National Policy

6. Other Submission Requirements Applications submitted under this

If the receipt date falls on a weekend program may be subject to the
or holiday, it will be extended to the See section IV.1 of this document. requirements of Executive Order 12372.
following workday. Responsive V. Application Review Information FDA’s conference grant program is
applications received after the quarterly described in the Catalog of Federal
deadline date will be held for the next 1. Criteria Domestic Assistance, No. 93.103. The
review cycle if the conference date falls Upon receipt, all applications applicable administrative regulations for
under the next cycle. Applications submitted in response to this this program are 45 CFR parts 74 and
received after the quarterly deadline announcement will be evaluated for 92. The legislative authority is title XVII
date for a conference within that review responsiveness to this RFA. of the Public Health Service Act.
cycle will be returned to the applicant Responsiveness is defined as
if not received in time for orderly 3. Reporting
submission of a complete application
processing. with original signatures within the A final Financial Status Report (SF–
Applications will be accepted during required submission dates (see 269) and a final progress report or
normal business hours, from 8 a.m. to Submission Dates and Times in section conference proceedings are required. An
4:30 p.m., Monday through Friday, on IV of this document). Applications original and two copies of these reports
or before the established receipt date. found to be nonresponsive will be must be submitted to the Grants
Applications will be considered on time returned to the applicant without Management Office (see section VII of
if sent, mailed, or electronically further consideration. this document), within 90 days after the
submitted on or before the appropriate An application will be considered end of the budget period of the grant
receipt date as evidenced by a legible nonresponsive if any of the following award. Copies of conference
U.S. Postal Service dated postmark or a criteria are not met: (1) If the applicant proceedings resulting from the meeting
legible date receipt from a commercial organization is ineligible, (2) if it is may be substituted for the final progress
carrier. Private metered postmarks will received in the grants management report. Failure to provide these reports
not be acceptable as proof of timely office after the specified receipt date in a timely manner may jeopardize
mailing. Applicants should note that the (see Submission Dates and Times in future grant support or delay an award.

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35106 Federal Register / Vol. 70, No. 115 / Thursday, June 16, 2005 / Notices

VII. Agency Contacts 552(b)(4)) and FDA’s implementing conduct or sponsor, and the respondent
For information regarding this regulations (21 CFR 20.61). is not required to respond to, an
program, please contact Tya Marks (see Unless disclosure is required under information collection that has been
Addresses to Request Applications in the Freedom of Information Act as extended, revised, or implemented on or
section IV of this document). amended (5 U.S.C. 552), as determined after October 1, 1995, unless it displays
by the freedom of information officials a currently valid OMB control number.
VIII. Other Information of HHS or by a court, data contained in Proposed Collection: Title: The
FDA strongly encourages all award the portions of this application that Agricultural Health Study—A
recipients to provide a smoke-free have been specifically identified by Prospective Cohort Study of Cancer and
workplace and to discourage the use of page number, paragraph, etc., by the Other Diseases Among Men and Women
all tobacco products. This is consistent applicant as containing restricted in Agriculture: Phase III. Type of
with FDA’s mission to protect and information, shall not be used or Information Collection Request: New.
advance the physical and mental health disclosed except for evaluation Need and Use of Information Collection:
of the American people. purposes. The purpose of this information
FDA is committed to achieving the Dated: June 10, 2005. collection is to update occupational and
health promotion and disease Jeffrey Shuren, environmental exposure information as
prevention objectives of ‘‘Healthy well as medical history information for
Assistant Commissioner for Policy.
People 2010,’’ a national effort designed subjects enrolled in the the Agricultural
[FR Doc. 05–11957 Filed 6–14–05; 10:57 am]
to reduce morbidity and mortality and Health Study. The primary objectives of
to improve quality of life. Applicants the study are to determine the health
may obtain a paper copy of the ‘‘Healthy effects resulting from occupational and
People 2010’’ objectives, vols. I and II, environmental exposures in the
for $70 ($87.50 foreign), S/N 017–000– agricultural environment. The findings
00550–9, by writing to the will provide valuable information
Superintendent of Documents, U.S. National Institutes of Health concerning the potential link between
Government Printing Office, P.O. Box agricultural exposures and cancer and
371954, Pittsburgh, PA 15250–7954. Submission for OMB Review; other chronic diseases among
Telephone orders can be placed to 202– Comment Request; The Agricultural Agricultural Health Study cohort
512–2250. The document is also Health Study: A Prospective Cohort members, and this information may be
available in CD–ROM format, S/N 017– Study of Cancer and Other Disease generalized to the entire agricultural
001–00549–5, for $19 ($23.50 foreign), Among Men and Women in Agriculture community.
as well as on the Internet at http:// under SUMMARY: Under the provisions of Frequency of Response: Single-time
‘‘Publications’’ (FDA has verified the section 3507(a)(1)(D) of the Paperwork reporting. Affected Public: Individuals
Web site address, but FDA is not Reduction Act of 1995, the National or households; Farms; Type of
responsible for subsequent changes to Cancer Institute (NCI), the National Respondents: Licensed pesticide
the Web site after the document Institutes of Health (NIH) has submitted applicators and their spouses. The
publishes in the Federal Register). to the Office of Management and Budget annual reporting burden is as follows:
Information collection requirements (OMB) a request for review and Estimated Number of Respondents:
requested on PHS Form SF–424 were approval of the information collection 74,320; Estimated Number of Responses
approved and issued under OMB listed below. This proposed information per Respondent: 1; Average Burden
Circular A–102. collection was previously published in Hours Per Response: .5845 for 72,320
Data included in the application, if the Federal Register on February 14, and 1.0 for 2,000; and Estimated Total
restricted with the legend specified in 2005, page 7509 and allowed 60-days Annual Burden Hours Requested:
this section of the document, may be for public comment. No public 44,270. The annualized cost to
entitled to confidential treatment as comments were received. The purpose respondents is estimated at:
trade secret or confidential commercial of this notice is to allow an additional $708,320.00. There are no Capital Costs
information within the meaning of the 30 days for public comment. The to report. There are no Operating or
Freedom of Information Act (5 U.S.C. National Institutes of Health may not Maintenance Costs to report.

Estimated Frequency of Average hours annual return
Type of respondent number of response per response hours re-
respondents quested

Private Applicators Interview only .................................................................. 39,479 1 0.5845 23,075.0

Interview and buccal cells ............................................................................. 1,100 1 1.0 1,100.0
Spouses Interview only .................................................................................. 30,054 1 0.5845 17,566.0
Interview and buccal cells ............................................................................. 820 1 1.0 820.0
Commercial Applicators Interview only .......................................................... 2,787 1 0.5845 1,629.0
Interview and buccal cells ............................................................................. 80 1 1.0 80.0

Total ........................................................................................................ 74,320 ........................ .......................... 44,270

Request for Comments: Written information is necessary for the proper of the burden of the proposed collection
comments and/or suggestions from the performance of the function of the of information, including the validity of
public and affected agencies are invited agency, including whether the the methodology and assumptions used;
on one or more of the following points: information will have practical utility; (3) ways to enhance the quality, utility,
(1) Whether the proposed collection of (2) the accuracy of the agency’s estimate and clarity of the information to be

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