Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order, 55922-55923 [2011-23106]
Download as PDF
<![CDATA[
55922
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
problems, product use errors, and
therapeutic failure (therapeutic
inequivalence). Reporting is supported
for all FDA-regulated human medical
care products, including drugs,
biologicals, medical devices, special
nutritional products, dietary
supplements, cosmetics, and
nonprescription (OTC) human drug
products marketed without an approved
application.
Qualitative assessment by social
scientists, and comments and feedback
from the public, have recognized that
Form FDA 3500 is written and
formatted at a literacy/
comprehensibility level that far exceeds
the level recommended for the general
public by health literacy experts and
does not conform to recommendations
in the Plain Writing Act of 2010 (https://
www.gpo.gov/fdsys/pkg/PLAW–
111publ274/pdf/PLAW–
111publ274.pdf).
The proposed consumer version of the
voluntary Form FDA 3500 will request
no new data from the voluntary reporter
not already included in the existing
Form FDA 3500 that is currently used
for reporting from both health care
professionals and consumers (patients).
Certain existing fields, not considered
essential data for the consumer report
but present on the standard (i.e., health
care professional) version of Form FDA
3500, have been eliminated to facilitate
and expedite consumer submissions and
reduce reporting burden. The formatting
and the plain language used is
compatible with the intent of the Plain
Writing Act and is expected to provide
non-health care professionals with a
second option to the existing Form FDA
3500 that will reduce the burden of
reporting by facilitating their
understanding of the requested data and
further clarify the voluntary reporting
process.
The proposed consumer version of
Form FDA 3500 evolved from several
iterations of draft versions, with input
from human factors experts, from other
regulatory agencies and with extensive
input from consumer advocacy groups
and the general public. The Agency
recognizes that many consumer
reporters have a preference for accessing
a copy of the voluntary reporting form
on the Internet or submitting to FDA
using an electronic version of the form.
The Agency currently supports
voluntary reporting with the forms
submitted by mail, by FAX, by
telephone via the toll free 800 number
and online at https://www.fda.gov/
medwatch/report.htm . It is the
Agency’s expectation that an approved
consumer version of the voluntary form
will be provided for consumer use by
these same channels.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
FDA Center FDA Form (21 CFR Section)
Center for Biologics Evaluation and Research/Center for
Drug Evaluation and Research:
Form 3500 ....................................................................
Form 3500A (§§ 310.305, 314.80, 314.98, and
600.80) ......................................................................
Center for Devices and Radiological Health:
Form 3500 ....................................................................
Form 3500A (§ 803) ......................................................
Center for Food Safety and Applied Nutrition:
Form 3500 ....................................................................
Form 3500A ..................................................................
Average
burden per
response
Total hours
1
28,952
0.6
17,371
599
96
57,504
1.1
63,254
4,585
1,485
1
225
4,585
334,125
0.6
1.1
2,751
367,538
297
1,039
1
1
297
1,039
0.6
1.1
178
1,143
........................
........................
........................
........................
452,235
are no capital costs or operating and maintenance costs associated with this collection of information.
VI. Reference
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Kessler, D.A., ‘‘Introducing MEDWatch:
A New Approach to Reporting Medication
and Device Adverse Effects and Product
Problems,’’ Journal of the American Medical
Association, vol. 269, pp. 2765–2768, 1993.
mstockstill on DSK4VPTVN1PROD with NOTICES
Total annual
responses
28,952
Total .......................................................................
1There
Number of
responses per
respondent
Dated: September 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23094 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0625]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
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
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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
requirements for filing objections and
requests for a hearing on a regulation or
order.
DATES: Submit either electronic or
written comments on the collection of
information by November 8, 2011.
ADDRESSES: 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
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
docket number found in brackets in the
heading of this document.
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
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
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.
Filing Objections and Requests for a
Hearing on a Regulation or Order—21
CFR Part 12—(OMB Control Number
0910–0184)—Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371(e)(2)), set forth the
55923
instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d) (21 CFR
12.20(d)). Objections and requests must
be submitted within the time specified
in § 12.20(e). Each objection for which
a hearing has been requested must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under 21 CFR 12.24 and do not
limit the evidence that may be
presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
12.22 ....................................................................................
3
1
3
20
60
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
collection of information is based on
past filings. Agency personnel
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order
estimate approximately three requests
are received by the Agency annually,
with each requiring approximately 20
hours of preparation time.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23106 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0480]
Draft Guidance for Industry:
Submission of Warning Plans for
Cigarettes and Smokeless Tobacco
Products; Availability; Agency
Information Collection Activities;
Proposed Collection; Comment
Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Submission of
Warning Plans for Cigarettes and
Smokeless Tobacco Products.’’ This
draft guidance document is intended to
assist persons submitting warning plans
to FDA under the Comprehensive
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:58 Sep 08, 2011
Jkt 223001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Smokeless Tobacco Health Education
Act, as amended by the Family Smoking
Prevention and Tobacco Control Act;
and under the Federal Cigarette
Labeling and Advertising Act, as
amended by the Family Smoking
Prevention and Tobacco Control Act,
when that requirement takes effect.
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 comment 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 8,
2011.
Submit either electronic or written
comments on the proposed collection of
information by November 8, 2011.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments, including comments
regarding the proposed collection of
information, to the Division of Dockets
Management (HFA–305), Food and Drug
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55922-55923]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0625]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Filing Objections and Requests for a Hearing on a
Regulation or Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 requirements for filing
objections and requests for a hearing on a regulation or order.
DATES: Submit either electronic or written comments on the collection
of information by November 8, 2011.
ADDRESSES: 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
[[Page 55923]]
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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 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.
Filing Objections and Requests for a Hearing on a Regulation or Order--
21 CFR Part 12--(OMB Control Number 0910-0184)--Extension
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), set
forth the instructions for filing objections and requests for a hearing
on a regulation or order under Sec. 12.20(d) (21 CFR 12.20(d)).
Objections and requests must be submitted within the time specified in
Sec. 12.20(e). Each objection for which a hearing has been requested
must be separately numbered and specify the provision of the regulation
or the proposed order. In addition, each objection must include a
detailed description and analysis of the factual information and any
other document, with some exceptions, supporting the objection. Failure
to include this information constitutes a waiver of the right to a
hearing on that objection. FDA uses the description and analysis to
determine whether a hearing request is justified. The description and
analysis may be used only for the purpose of determining whether a
hearing has been justified under 21 CFR 12.24 and do not limit the
evidence that may be presented if a hearing is granted.
Respondents to this information collection are those parties that
may be adversely affected by an order or regulation.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
12.22.............................................................. 3 1 3 20 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this collection of information is based on
past filings. Agency personnel responsible for processing the filing of
objections and requests for a public hearing on a specific regulation
or order estimate approximately three requests are received by the
Agency annually, with each requiring approximately 20 hours of
preparation time.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23106 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P
