Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile, 56588 [2014-22452]
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56588
Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Focus groups ....................................................
Customer comment cards/forms ......................
Small discussion groups ...................................
Customer satisfaction surveys ..........................
725
1,200
725
6,450
1
1
1
1
725
1,200
725
6,450
Total ...........................................................
........................
........................
........................
1 There
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–22461 Filed 9–19–14; 8:45 am]
BILLING CODE 4164–01–P
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–22452 Filed 9–19–14; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2013–N–1164]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Exceptions Or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
On July
22, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Exceptions Or Alternatives to
Labeling Requirements for Products
Held by the Strategic National
Stockpile’’ 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 0910–0614. The
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:07 Sep 19, 2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Estradiol Vaginal Cream; Draft
Guidance for Industry; Availability
AGENCY:
SUMMARY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
...................................
(15 minutes) .............
...................................
(20 minutes) .............
1,269
300
1,269
2,129
...........................................
4,967
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
1.75
0.25
1.75
0.33
Total hours
Jkt 232001
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Draft Guidance on
Estradiol.’’ The guidance provides
specific recommendations on the design
of bioequivalence (BE) studies to
support abbreviated new drug
applications (ANDAs) for estradiol
vaginal cream. This draft guidance is a
revised version of a previously issued
draft guidance of the same subject.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 21,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kris
´
Andre, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1615, Silver Spring,
MD 20993, 240–402–7800.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm. As described in
that guidance, FDA adopted this process
as a means to develop and disseminate
product-specific BE recommendations
and to provide a meaningful
opportunity for the public to consider
and comment on those
recommendations. This notice
announces the availability of revised
draft BE recommendations for estradiol
vaginal cream.
ANDA 086069 for Estrace Cream
(estradiol vaginal cream, USP, 0.01%)
was initially approved by FDA in
January 1984. In August 2009, FDA
issued a draft guidance for industry on
BE recommendations for generic
estradiol vaginal cream. FDA is now
issuing a revised version of the draft BE
recommendations for estradiol vaginal
cream. This revised draft guidance
changes the recommendation for an in
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Page 56588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22452]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1164]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Exceptions or Alternatives to
Labeling Requirements for Products Held by the Strategic National
Stockpile
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Exceptions Or Alternatives to
Labeling Requirements for Products Held by the Strategic National
Stockpile'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On July 22, 2014, the Agency submitted a
proposed collection of information entitled ``Exceptions Or
Alternatives to Labeling Requirements for Products Held by the
Strategic National Stockpile'' 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 0910-0614.
The approval expires on August 31, 2017. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22452 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P
