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4234 Federal Register / Vol. 73, No.

16 / Thursday, January 24, 2008 / Notices

document in the Federal Register. dockets/ecomments or http:// respondents, including through the use
Therefore, a comment is best assured of www.regulations.gov. Submit written of automated collection techniques,
having its full effect if OMB receives it comments on the collection of when appropriate, and other forms of
within 30 days of publication. Written information to the Division of Dockets information technology.
comments and recommendations for the Management (HFA–305), Food and Drug
Customer/Partner Service Surveys
proposed information collection should Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All (OMB Control Number 0910–0360)—
be sent directly to the following:
Office of Management and Budget, comments should be identified with the Extension
Paperwork Reduction Project, Fax: 202– docket number found in brackets in the Under section 903 of the Federal
395–6974, Attn: Desk Officer for the heading of this document. Food, Drug, and Cosmetic Act (21 U.S.C.
Administration for Children and FOR FURTHER INFORMATION CONTACT: 393), FDA is authorized to conduct
Families. Jonna Capezzuto, Office of the Chief research and public information
Janean Chambers, Information Officer (HFA–250), Food programs about regulated products and
Reports Clearance Officer.
and Drug Administration, 5600 Fishers responsibilities of the agency. Executive
Lane, Rockville, MD 20857, 301–827– Order 12862, entitled ‘‘Setting Customer
[FR Doc. 08–246 Filed 1–23–08; 8:45 am]
4659. Service Standard,’’ directs Federal
BILLING CODE 4184–01–M
SUPPLEMENTARY INFORMATION: Under the agencies that ‘‘provide significant
PRA (44 U.S.C. 3501–3520), Federal services directly to the public’’ to
DEPARTMENT OF HEALTH AND agencies must obtain approval from the ‘‘survey customers to determine the
HUMAN SERVICES Office of Management and Budget kind and quality of services they want
(OMB) for each collection of and their level of satisfaction with
Food and Drug Administration information they conduct or sponsor. existing services.’’ FDA is seeking OMB
[Docket No. 2008N–0009]
‘‘Collection of information’’ is defined clearance to conduct a series of surveys
in 44 U.S.C. 3502(3) and 5 CFR to implement Executive Order 12862.
Agency Information Collection 1320.3(c) and includes agency requests Participation in the surveys is
Activities; Proposed Collection; or requirements that members of the voluntary. This request covers
Comment Request; Customer/Partner public submit reports, keep records, or customer/partner service surveys of
Service Surveys provide information to a third party. regulated entities, such as food
Section 3506(c)(2)(A) of the PRA (44 processors; cosmetic drug, biologic and
AGENCY: Food and Drug Administration, U.S.C. 3506(c)(2)(A)) requires Federal medical device manufacturers;
HHS. agencies to provide a 60-day notice in consumers; and health professionals.
ACTION: Notice. the Federal Register concerning each The request also covers ‘‘partner’’ (State
proposed collection of information, and local governments) customer
SUMMARY: The Food and Drug
including each proposed extension of an service surveys.
Administration (FDA) is announcing an
existing collection of information, FDA will use the information from
opportunity for public comment on the
before submitting the collection to OMB these surveys to identify strengths and
proposed collection of certain
for approval. To comply with this weaknesses in service to customers/
information by the agency. Under the
requirement, FDA is publishing notice partners and to make improvements.
Paperwork Reduction Act of 1995 (the
of the proposed collection of The surveys will measure timeliness,
PRA), Federal agencies are required to
information set forth in this document. appropriateness and accuracy of
publish notice in the Federal Register With respect to the following
concerning each proposed collection of information, courtesy, and problem
collection of information, FDA invites resolution in the context of individual
information, including each proposed comments on these topics: (1) Whether
extension of an existing collection of programs.
the proposed collection of information
information, and to allow 60 days for is necessary for the proper performance FDA estimates conducting 15
public comment in response to the of FDA’s functions, including whether customer/partner service surveys per
notice. This notice solicits comments on the information will have practical year, each requiring an average of 18
voluntary customer satisfaction service utility; (2) the accuracy of FDA’s minutes for review and completion. We
surveys to implement Executive Order estimate of the burden of the proposed estimate respondents to these surveys to
12862. collection of information, including the be between 50 and 6,000 customers.
DATES: Submit written or electronic validity of the methodology and Some of these surveys will be repeats of
comments on the collection of assumptions used; (3) ways to enhance earlier surveys for purposes of
information by March 24, 2008. the quality, utility, and clarity of the monitoring customer/partner service
ADDRESSES: Submit electronic information to be collected; and (4) and developing long-term data.
comments on the collection of ways to minimize the burden of the FDA estimates the burden of this
information to: http://www.fda.gov/ collection of information on collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1


No. of Annual Frequency Hours per
Type of Survey Total Hours
Respondents per Response Response

Mail, telephone, fax, web-based 15,000 1 .30 4,500


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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. 73, No. 16 / Thursday, January 24, 2008 / Notices 4235

Dated: January 9, 2008. found at the IHS Web site at: http:// Tribal colleges meeting the definition of
Jeffrey Shuren, www.ihs.gov/NonMedicalPrograms/ a Tribal organization as defined by 25
Assistant Commissioner for Policy. IHS_Stats. Although the AI/AN U.S.C. 1603(e)) and institutions that
[FR Doc. E8–1200 Filed 1–23–08; 8:45 am] mortality rates for all cancers are about conduct intensive academic-level
BILLING CODE 4160–01–S
20 percent lower than the U.S. rates for biomedical, behavioral and health
all races, there is variation among IHS services research. These partnerships
Areas for specific cancers. Moreover, the are called Native American Research
DEPARTMENT OF HEALTH AND favorable AI/AN mortality rates for Centers for Health (NARCH). Due to the
HUMAN SERVICES some cancers may be due to markedly complexity of factors contributing to the
lower incidence rates partly offset by health and disease of AI/ANs, and to
Indian Health Service higher case-fatality rates. Unfamiliarity their health disparities compared with
with modern health care may adversely other Americans, the collaborative
Native American Research Centers for influence health status among the efforts of the agencies of the Department
Health (NARCH) Grants elderly, the low-income elderly, and of Health and Human Services (HHS)
Tribes, and also may reduce the and the collaboration of researchers and
Announcement Type: New and
acceptability of health research among AI/AN communities are needed to
Competing Continuations.
them. The daunting tasks confronting achieve significant improvements in the
Funding Announcement Number:
Tribes, researchers, and health care and health status of AI/AN people. To
HHS–2009–IHS–NARCHV–0001.
public health programs in the beginning accomplish this goal, in addition to
Catalog of Federal Domestic
of the twenty-first century are to resume objectives set by the Tribe, Tribal
Assistance Number(s): 93.933.
the reduction of health disparities that Organization or Indian Health Boards,
Key Dates: Letter of Intent Deadline:
had occurred through the 1980s, to the IHS NARCH program will pursue
March 15, 2008.
reverse the worsening in a few diseases, the following program objectives:
Application Deadline Date: May 16, • To develop a cadre of AI/AN
to maintain and strengthen the favorable
2008. scientists and Health Professionals—
status, and to reduce the disparities
Review Date: October, 2008. Opportunities are needed to develop
among and within Areas and Tribes.
Earliest Anticipated Start Date: June more AI/AN scientists and health
Factors known to contribute to health
1, 2009. professionals engaged in research, and
status and disparities are complex, and
I. Funding Opportunity Description include underlying biology, physiology, to conduct biomedical, clinical,
and genetics, as well as ethnicity, behavioral and health services research
The Indian Health Service (IHS), in that is responsive to the needs of the AI/
conjunction with the National Institute culture, socioeconomic status, gender/
sex, age, geographical access to care, AN community and the goals of this
of General Medical Sciences (NIGMS) initiative. Faculty/researchers and
and other institutes of the National and levels of insurance. Additional
factors known to contribute to health students at each proposed NARCH will
Institutes of Health (NIH) announces develop investigator-initiated,
competitive grant applications for status and dispariteis include:
1. Family, home, and work scientifically meritorious research
Native American Research Centers for projects, including pilot research
environments;
Health (NARCH), an initiative to 2. General or culturally specific health projects, and will be supported through
support new and/or continuing centers practices; science education projects designed to
or projects funded under the NARCH 3. Social support systems; increase the numbers of, and to improve
grant program. This funding mechanism 4. Lack of access to culturally- the research skills of, AI/AN
will develop further opportunities for appropriate health care; and investigators and investigators involved
conducting research and research 5. Attitudes toward health. with AI/ANs.
training to meet the needs of American Yet none of these along or in • To enhance Partnerships and
Indian/Alaska Native (AI/AN) combination accounts for all reduce distrust of research by AI/AN
communities. This program is documented differences. Health communities—Recent community-based
authorized under the Snyder Act, 25 disparities of AI/ANs may also reflect a participatory research suggests that AI/
U.S.C. 13, the Public Health Service Act, lack of in-depth research relevant to AN communities can work
42 U.S.C. 241 as amended, and the improving their health status. Many AI/ collaboratively in partnership with
Indian Health Care Improvement Act, 25 ANs distrust research for historical health researchers to further the
U.S.C. 1602(a)(b)(16). This program is reasons. One approach that combats this research needs of AI/ANs. Fully
described at 93.933 in the Catalog of distrust is to ensure that Tribes are the utilizing all cultural and scientific
Federal Domestic Assistance. managing partners in training and knowledge, strengths, and
Background Information: TheAI/AN research that involves them, as for competencies, such partnerships can
Tribal nations and communities have example, in community-based lead to better understanding of the
long experienced health status worse participatory research (CBPR) (i.e., a biological, genetic, behavioral,
than that of other Americans. Although collaborative research process between psychological, cultural, social, and
major gains in reducing health researchers and community economic factors either promoting or
disparities were made during the last representatives). This approach is hindering improved health status of AI/
half of the twentieth century, most gains especially helpful to design both ANs, and generate the development and
stopped by the mid-1980s (Trends in training relevant to researchers from evaluation of interventions to improve
Indian Health 1998–99) and a few Tribal communities, and research their health status. Community distrust
diseases, e.g., diabetes, worsened. ‘‘All relevant to the health needs of the of research and researchers will be
Indian’’ rates contain marked variation communities. reduced by offering the Tribe greater
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among the IHS Areas or regions Research Objectives: The NARCH control over the research process.
(Regional Differences in Indian Health initiative will support partnerships • To Reduce Health Disparities—In
1998–99); and variation by Tribe exists between Federally Recognized AI/AN the Indian Health Care Improvement
within Areas as well. The Trends and Tribes Organizations (including national Act, Pub. L. 94–437 (as amended), IHS
Regional Differences reference can be and area Indian Health Boards, and was legislatively mandated to improve

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