Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey of “Health Care Providers' Responses to Medical Device Labeling”, 42502 [2012-17555]
Download as PDF
<![CDATA[
42502
Federal Register / Vol. 77, No. 139 / Thursday, July 19, 2012 / Notices
was sought prior to the formal appeal,
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
information that the Agency suggests
submitting with a formal request for
dispute resolution consists of: (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.
Description of respondents: A
sponsor, applicant, or manufacturer of a
drug or biological product regulated by
the Agency under the Federal Food,
Drug, and Cosmetic Act or section 351
of the Public Health Service Act (42
U.S.C. 262) (Pub. L. 99–660) who
requests formal resolution of a scientific
or procedural dispute.
Burden Estimate: Provided in this
document 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 nine 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 18 requests annually and
CBER receives approximately 1 request
annually. The hours per response is 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 152 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
In the Federal Register of March 20,
2012 (77 FR 16237), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments on the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
responses per
respondent
Number of
respondents
Requests for formal dispute resolution
Total annual
responses
Average
burden
per response
Total hours
CDER ...................................................................................
CBER ...................................................................................
9
1
2
1
18
1
8
8
144
8
Total ..............................................................................
........................
........................
........................
........................
152
Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
ACTION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with NOTICES
[Docket No. FDA–2011–N–0766]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Survey of ‘‘Health Care Providers’
Responses to Medical Device
Labeling’’
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
17:10 Jul 18, 2012
Jkt 226001
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
Survey of ‘‘Health Care Providers’
Responses to Medical Device Labeling’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
8, 2012, the Agency submitted a
proposed collection of information
entitled Survey of ‘‘Health Care
Providers’ Responses to Medical Device
SUMMARY:
[FR Doc. 2012–17556 Filed 7–18–12; 8:45 am]
AGENCY:
Notice.
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
Labeling’’ 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 0910–0715. The
approval expires on July 31, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17555 Filed 7–18–12; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 77, Number 139 (Thursday, July 19, 2012)]
[Notices]
[Page 42502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17555]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0766]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Survey of ``Health Care Providers'
Responses to Medical Device Labeling''
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled Survey of ``Health Care Providers'
Responses to Medical Device Labeling'' has been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March 8, 2012, the Agency submitted a
proposed collection of information entitled Survey of ``Health Care
Providers' Responses to Medical Device Labeling'' 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
0910-0715. The approval expires on July 31, 2015. A copy of the
supporting statement for this information collection is available on
the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17555 Filed 7-18-12; 8:45 am]
BILLING CODE 4160-01-P
