Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements, 40376-40377 [2011-17140]
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40376
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
The reconsideration and appeal
requests are not addressed in the FD&C
Act but are discussed in the draft
guidance. We estimate that we will
receive three requests for
reconsideration annually, and that the
total average burden hours for a
reconsideration request will be 24
hours. We estimate that we will receive
one request annually for an appeal of a
user fee waiver determination, and that
the time needed to prepare an appeal
would be approximately 12 hours.
Reconsideration requests are sent to the
Associate Director for Policy at the
Center for Drug Evaluation and Research
(CDER), and requests for appeals are
sent to the User Fee Appeals Officer at
FDA, with a copy to the Associate
Director for Policy at CDER. We have
also included in this estimate both the
time needed to prepare the request for
appeal and the time needed to create
and send a copy of the request for an
appeal to the Associate Director for
Policy at CDER.
The burden for filling out and
submitting Form FDA 3397
(Prescription Drug User Fee Coversheet)
has not been included in the burden
analysis because that information
collection is already approved by OMB
under OMB control number 0910–0297.
The collections of information
associated with a new drug application
or biologics license application have
been approved under OMB control
numbers 0910–0001 and 0910–0338,
respectively.
We have included in the burden
estimate the preparation and submission
of application fee waivers for small
businesses because small businesses
requesting a waiver must submit
documentation to FDA on the number of
their employees and must include the
information that the application is the
first human drug application, within the
meaning of the FD&C Act, to be
submitted to the Agency for approval.
Because the Small Business
Administration (SBA) makes the size
determinations for FDA, small
businesses must also submit
information to the SBA. The submission
of information to SBA is already
approved by OMB under OMB control
number 3245–0101.
In the Federal Register of March 14,
2011 (76 FR 13629), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Section 736 of the FD&C Act ............................................
Reconsideration Requests .................................................
Appeal Requests ................................................................
75
3
1
1.2
1
1
90
3
1
16
24
12
1,440
72
12
Total ............................................................................
........................
..........................
........................
........................
1,524
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Fax written comments on the
collection of information by August 8,
2011.
DATES:
[FR Doc. 2011–17142 Filed 7–7–11; 8:45 am]
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0482. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0595]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
mstockstill on DSK4VPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
VerDate Mar<15>2010
17:52 Jul 07, 2011
Jkt 223001
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794; Jonna.Capezzuto@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:.
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
Sfmt 4703
Exports: Notification and
Recordkeeping Requirements—21 CFR
Part 1 (OMB Control Number 0910–
0482—Extension
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or marketed in the United.States as
allowed under section 801(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act (21 U.S.C. 381)). In
general, the notification identifies the
product being exported (e.g. name,
description, and in some cases, country
of destination) and specifies where the
notification should be sent. These
notifications are sent only for an initial
export; subsequent exports of the same
product to the same destination (or, in
the case of certain countries identified
in section 802(b) of the FD&C Act (21
U.S.C. 382) would not result in a
notification to FDA.
The recordkeepers to this information
collection are exporters who export
human drugs, biologics, devices, animal
drugs, foods and cosmetics that may not
be sold in the United States and
maintain records demonstrating their
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08JYN1
40377
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
compliance with the requirements in
section 801(e)(1) of the FD&C Act.
In the Federal Register of December 6,
2010 (75 FR 75677), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
1.101 (d) ...............................................................................
400
3
1,200
15
18,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
21 CFR section
Number of
record-keepers
Annual
frequency of
recordkeeping
Total annual
records
Hours per
recordkeeper
Total hours
1.101(b), (c), (e) ...................................................................
320
3
960
22
21,120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17140 Filed 7–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0492]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Class II Special
Controls Guidance Document:
Labeling for Natural Rubber Latex
Condoms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection requirements for
the labeling of natural rubber latex
condoms.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Submit either electronic or
written comments on the collection of
information by September 6, 2011.
DATES:
VerDate Mar<15>2010
17:52 Jul 07, 2011
Jkt 223001
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
ADDRESSES:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21
CFR 884.5300—(OMB Control Number
0910–0633)—Extension
Under the Medical Device
Amendments of 1976 (Pub. L. 94–295),
class II devices were defined as those
devices for which there was insufficient
information to show that general
controls themselves would provide a
reasonable assurance of safety and
effectiveness, but for which there was
sufficient information to establish
performance standards to provide such
assurance.
Condoms without spermicidal
lubricant containing nonoxynol-9 are
classified in class II. They were
originally classified before the
enactment of provisions of the Safe
Medical Devices Act of 1990 (Pub. L.
101–629) that broadened the definition
of class II devices and now permit FDA
to establish special controls beyond
performance standards, including
guidance documents, to help provide
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08JYN1
]]>Agencies
[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40376-40377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17140]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0595]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exports: Notification
and Recordkeeping Requirements
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 Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
8, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0482.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794; Jonna.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance:.
Exports: Notification and Recordkeeping Requirements--21 CFR Part 1
(OMB Control Number 0910-0482--Extension
The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or marketed in the United.States as allowed under
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act (21 U.S.C. 381)). In general, the notification identifies the
product being exported (e.g. name, description, and in some cases,
country of destination) and specifies where the notification should be
sent. These notifications are sent only for an initial export;
subsequent exports of the same product to the same destination (or, in
the case of certain countries identified in section 802(b) of the FD&C
Act (21 U.S.C. 382) would not result in a notification to FDA.
The recordkeepers to this information collection are exporters who
export human drugs, biologics, devices, animal drugs, foods and
cosmetics that may not be sold in the United States and maintain
records demonstrating their
[[Page 40377]]
compliance with the requirements in section 801(e)(1) of the FD&C Act.
In the Federal Register of December 6, 2010 (75 FR 75677), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (d).......................................................... 400 3 1,200 15 18,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Number of frequency of Total annual Hours per Total hours
record-keepers recordkeeping records recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(b), (c), (e)................................................. 320 3 960 22 21,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17140 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P
