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6728 Federal Register / Vol. 73, No.

24 / Tuesday, February 5, 2008 / Notices

by prospectively studying children who participating in a phone survey (no development, the health status, and the
were born with this potentially more than 40 minutes) or an in-person onset of complications among children
disabling condition. We estimate to assessment (no more than 2 hrs). For with SB in order that effective
enroll approximately 40 parents with a families who participate in the in- interventions may be identified that will
child with Spina Bifida ages 3-, 4-, or 5- person assessment, (estimated to be ameliorate the course of this complex,
years of age, and 20 of the children of twenty of the forty families); the child multi-system condition. Long-term
these forty parents. The data to be will also be invited to participate in a results will help determine if it would
collected will relate to medical concerns child-appropriate assessment. Data will be beneficial to systematically screen
prevalent among individuals with Spina also be collected on the actual children with Spina Bifida for certain
Bifida in the areas of neurology/ recruitment process. Results from the health related, educational and
neurosurgery, urology, and orthopedics; project will be evaluated and developmental problems that these
development and learning; nutrition disseminated to provide guidance for children are at an increased risk of
and physical growth; mobility and states that are interested in following experiencing and at what age such a
functioning; general health; and family children with Spina Bifida screening should be performed.
demographics. Families interested in prospectively. The proposed project is There will be no cost to the
participating can choose between the initial step to document the respondents other than their time.


Number of
Number of burden per Total burden
Respondents responses per
respondents response hours
respondent (in minutes)

Parents (phone survey) ................................................................................... 20 1 40/60 13

Parents (in-person assessment) ...................................................................... 20 1 2 40
Child (in-person assessment) .......................................................................... 20 1 1 20

Total .......................................................................................................... ........................ ........................ ........................ 73

Dated: January 25, 2008. and Obesity Prevention (CUCH) and ADDRESSES: To ensure that comments on
Maryam I. Daneshvar, insert the Division of Nutrition, Physical the information collection are received,
Acting Reports Clearance Officer, Centers for Activity, and Obesity (CUCH). OMB recommends that written
Disease Control and Prevention. Dated: January 28, 2008. comments be faxed to the Office of
[FR Doc. E8–1993 Filed 2–4–08; 8:45 am] Joseph Henderson, M.P.A., Information and Regulatory Affairs,
BILLING CODE 4163–18–P Acting Chief Operating Officer, Centers for
OMB, Attn: FDA Desk Officer, FAX:
Disease Control and Prevention (CDC). 202–395–6974, or e-mailed to
[FR Doc. 08–486 Filed 2–4–08; 8:45 am] All comments
DEPARTMENT OF HEALTH AND should be identified with the OMB
HUMAN SERVICES control number 0910–0551. Also
include the FDA docket number found
Centers for Disease Control and in brackets in the heading of this
Prevention document.
Statement of Organization, Functions, FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration Denver Presley Jr.,Office of the Chief
and Delegations of Authority
[Docket No. FDA–2008–N–0051] (formerly Information Officer (HFA–250), Food
Part C (Centers for Disease Control Docket No. 2007N–0422) and Drug Administration,5600 Fishers
and Prevention) of the Statement of Lane, Rockville, MD 20857, 301–827–
Organization, Functions, and Agency Information Collection 1472.
Delegations of Authority of the Activities; Submission for Office of
Department of Health and Human Management and Budget Review;
compliance with 44 U.S.C. 3507, FDA
Services (45 FR 67772–76, dated Comment Request; Application for
has submitted the following proposed
October 14, 1980, and corrected at 45 FR Participation in the Medical Device
collection of information to OMB for
69296, October 20, 1980, as amended Fellowship Program
review and clearance.
most recently at 72 FR 67308, dated AGENCY: Food and Drug Administration,
November 28, 2007) is amended to Application for Participation in the
reflect the title change for the Division Medical Device Fellowship Program;
ACTION: Notice. (OMB Control Number 0910–0551)—
of Nutrition, Physical Activity, and
Obesity Prevention, National Center for SUMMARY: The Food and Drug Extension
Chronic Disease Prevention and Health Administration (FDA) is announcing Sections 1104, 1302, 3301, 3304,
Promotion, Coordinating Center for that a proposed collection of 3320, 3361, 3393, and 3394 of title 5 of
Health Promotion, Centers for Disease information has been submitted to the the United States Code, authorize
Control and Prevention. Office of Management and Budget Federal agencies to rate applicants for
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Section C–B, Organization and (OMB) for review and clearance under Federal jobs. Collecting applications for
Functions, is hereby amended as the Paperwork Reduction Act of 1995. the Medical Device Fellowship Program
follows: DATES: Fax written comments on the will allow FDA’s Center for Devices and
Delete in its entirety the title for the collection of information by March 6, Radiological Health (CDRH) to easily
Division of Nutrition, Physical Activity, 2008. and efficiently elicit and review

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Federal Register / Vol. 73, No. 24 / Tuesday, February 5, 2008 / Notices 6729

information from students and health misrouted within the agency mail a 60-day notice requesting public
care professionals who are interested in system. It will assist the agency in comment on the information collection
becoming involved in CDRH activities. promoting and protecting the public provisions. No comments were received.
The process will reduce the time and health by encouraging outside persons FDA estimate of the burden for this
cost of submitting written to share their expertise with CDRH. collection of information is as follows:
documentation to the agency and lessen In the Federal Register of November
the likelihood of applications being 9, 2007 (72 FR 63614), FDA published


5 U.S.C. Section/ No. of Annual Frequency Total Annual Hours per Total Hours
FDA Form No. Respondents per Response Responses Response

1104, 1302, 3301, 3304, 3320, 3361,

3393, 3394/
Form No. 3608 250 1 250 1 250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA based these estimates on the clearance under 44 U.S.C. 3507. An information collection requirements for
number of inquiries that have been agency may not conduct or sponsor, and the tracking of medical devices.
received concerning the program and a person is not required to respond to, DATES: Submit written or electronic
the number of requests for application a collection of information unless it comments on the collection of
forms over the past 3 years. displays a currently valid OMB control information by April 7, 2008.
Dated: January 30, 2008. number. OMB has now approved the ADDRESSES: Submit electronic
Jeffrey Shuren, information collection and has assigned comments on the collection of
Assistant Commissioner for Policy.
OMB control number 0910–0459. The information to http://
approval expires on January 31, 2011. A Submit written
[FR Doc. E8–2068 Filed 2–4–08; 8:45 am]
copy of the supporting statement for this comments on the collection of
information collection is available on information to the Division of Dockets
the Internet at Management (HFA–305), Food and Drug
DEPARTMENT OF HEALTH AND public/do/PRAMain. Administration, 5630 Fishers Lane, rm.
HUMAN SERVICES Dated: January 30, 2008. 1061, Rockville, MD 20852. All
Jeffrey Shuren, comments should be identified with the
Food and Drug Administration Assistant Commissioner for Policy. docket number found in brackets in the
[Docket No. FDA–2008–N–0048] (formerly [FR Doc. E8–2076 Filed 2–4–08; 8:45 am] heading of this document.
Denver Presley, Jr., Office of the Chief
Agency Information Collection Information Officer (HFA–250), Food
Activities; Announcement of Office of DEPARTMENT OF HEALTH AND and Drug Administration,5600 Fishers
Management and Budget Approval; HUMAN SERVICES Lane, Rockville, MD 20857, 301 827–
Information Program on Clinical Trials 1472.
for Serious and Life-Threatening Food and Drug Administration
Diseases: Maintaining a Databank SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
AGENCY: Food and Drug Administration, [Docket No. FDA–2008–N–0050] agencies must obtain approval from the
HHS. Office of Management and Budget
Agency Information Collection
ACTION: Notice. (OMB) for each collection of
Activities; Proposed Collection;
Comment Request; Medical Devices; information they conduct or sponsor.
SUMMARY: The Food and Drug
Device Tracking ‘‘Collection of information’’ is defined
Administration (FDA) is announcing in 44 U.S.C. 3502(3) and 5 CFR
that a collection of information entitled 1320.3(c) and includes agency requests
AGENCY: Food and Drug Administration,
‘‘Information Program on Clinical Trials or requirements that members of the
for Serious and Life-Threatening public submit reports, keep records, or
Diseases: Maintaining a Databank’’ has ACTION: Notice.
provide information to a third party.
been approved by the Office of SUMMARY: The Food and Drug Section 3506(c)(2)(A) of the PRA (44
Management and Budget (OMB) under Administration (FDA) is announcing an U.S.C. 3506(c)(2)(A)) requires Federal
the Paperwork Reduction Act of 1995. opportunity for public comment on the agencies to provide a 60-day notice in
FOR FURTHER INFORMATION CONTACT: proposed collection of certain the Federal Register concerning each
Jonna Capezzuto, Office of the Chief information by the agency. Under the proposed collection of information
Information Officer (HFA–250), Food Paperwork Reduction Act of 1995 (the including each proposed extension of an
and Drug Administration, 5600 Fishers PRA), Federal agencies are required to existing collection of information,
Lane, Rockville, MD 20857, 301–827– publish notice in the Federal Register before submitting the collection to OMB
4659. concerning each proposed collection of for approval. To comply with this
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SUPPLEMENTARY INFORMATION: In the information, including each proposed requirement, FDA is publishing notice
Federal Register of October 19, 2007 (72 extension of an existing collection of of the proposed collection of
FR 59295), the agency announced that information, and to allow 60 days for information set forth in this document.
the proposed information collection had public comment in response to the With respect to the following
been submitted to OMB for review and notice. This notice solicits comments on collection of information, FDA invites

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