Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; 2005 Food Safety Survey, 61455 [05-21157]
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61455
Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices
whether advisory committee review is
sought, and the expected outcome; (2) a
statement identifying the review
division/office that issued the original
decision on the matter and, if
applicable, the last agency official that
attempted to formally resolve the
matter; (3) a list of documents in the
administrative file, or additional copies
of such documents, that are deemed
necessary for resolution of the issue(s);
and (4) a statement that the previous
supervisory level has already had the
opportunity to review all of the material
relied on for dispute resolution. The
agency suggests submitting the
following information with a formal
request for dispute resolution: (1)
Statements describing the issue from the
perspective of the person with a
dispute, (2) brief statements describing
the history of the matter, and (3) the
documents previously submitted to FDA
under an OMB approved collection of
information.
Based on FDA’s experience with
dispute resolution, the agency expects
that most persons seeking formal
dispute resolution will have gathered
the materials listed previously when
identifying the existence of a dispute
with the agency. Consequently, FDA
anticipates that the collection of
information attributed solely to the
guidance will be minimal.
Respondents are expected to be
sponsors, applicants, or manufacturers
of drug or biological products regulated
by the agency under section 505 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C.
262) who request formal resolution of a
scientific or procedural dispute.
Provided below is an estimate of the
annual reporting burden for requests for
dispute resolution. Based on data
collected from review divisions and
offices within CDER and CBER, FDA
estimates that approximately eight
sponsors and applicants (respondents)
submit requests for formal dispute
resolution to CDER annually and
approximately one respondent submits
requests for formal dispute resolution to
CBER annually. The total annual
responses are the total number of
requests submitted to CDER and CBER
in 1 year, including requests for dispute
resolution that a single respondent
submits more than one time. FDA
estimates that CDER receives
approximately 10 requests annually and
CBER receives approximately 1 request
annually. The hours per response are
the estimated number of hours that a
respondent would spend preparing the
information to be submitted with a
request for formal dispute resolution in
accordance with this guidance,
including the time it takes to gather and
copy brief statements describing the
issue from the perspective of the person
with the dispute, brief statements
describing the history of the matter, and
supporting information that has already
been submitted to the agency. Based on
experience, FDA estimates that
approximately 8 hours on average
would be needed per response.
Therefore, FDA estimates that 88 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Requests for Formal Dispute
Resolution
No. of
Respondents
Number of Responses
per Respondent
CDER
8
1.25
CBER
1
Total Annual
Responses
1
Hours per
Response
Total Hours
10
8
80
1
8
8
Total
88
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21156 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2004N–0516]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
2005 Food Safety Survey
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘2005 Food Safety Survey’’ has been
approved by the Office of Management
SUMMARY:
VerDate Aug<31>2005
15:19 Oct 21, 2005
Jkt 208001
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of May 24, 2005 (70 FR
29768), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0345. The
approval expires on February 30, 2008.
A copy of the supporting statement
for this information collection is
available on the Internet at https://
www.fda.gov/ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21157 Filed 10–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0216]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices:
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
E:\FR\FM\24OCN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Page 61455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0516]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; 2005 Food Safety Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``2005 Food Safety Survey'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 24, 2005 (70
FR 29768), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0345.
The approval expires on February 30, 2008.
A copy of the supporting statement for this information collection
is available on the Internet at https://www.fda.gov/ohrms/dockets.
Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21157 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S
