Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application, 80946-80947 [2011-33140]
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Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices
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Jkt 226001
Agency for Toxic Substances and
Disease Registry.
Dated: December 20, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–33092 Filed 12–23–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0915]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Nonprescription
Human Drug Products Marketed
Without an Approved Application
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
the FDA guidance for industry on
‘‘Postmarketing Adverse Event
Reporting for Nonprescription Human
Drug Products Marketed Without an
Approved Application.’’ This guidance
document provides recommendations
on postmarketing serious adverse event
reporting for nonprescription (over-thecounter) human drugs marketed without
an approved application. It provides
recommendations on the minimum data
elements that should be included in a
serious adverse event report, the label
that should be included with the report,
reporting formats for paper and
electronic submissions, and how and
where to submit the reports.
DATES: Submit either electronic or
written comments on the collection of
information by February 27, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
SUMMARY:
PO 00000
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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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.
PI50–400B, Rockville, MD 20850, (301)
796–7651,
juanmanuel.vilela@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.
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application—(OMB Control
Number 0910–0636)—Extension
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
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Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices
section 502(b)(1) (21 U.S.C. 352(b)(1)) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act)) appears on the label of
a nonprescription drug marketed in the
United States.
FDA is requesting public comment on
estimates of annual submissions from
these respondents, as required by the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (Public Law 109–462)
and described in the guidance. This
guidance document discusses what
should be included in a serious adverse
drug event report submitted under
section 760(b)(1) (21 U.S.C. 379aa(b)(1))
of the FD&C Act, including followup
reports under 760(c)(2) (21 U.S.C.
379aa(c)(2)) of the FD&C Act, and how
to submit these reports. The estimates
for annual reporting burden and
recordkeeping are based on FDA’s
knowledge of adverse drug experience
reports historically submitted per year
for prescription drug products and for
nonprescription drug products marketed
under an approved application,
including knowledge about the time
needed to prepare the reports and to
maintain records.
FDA receives approximately 2,500
serious adverse event reports for
nonprescription drug products marketed
under approved applications, which
comprise approximately 20 percent of
the overall nonprescription drug market.
Based on this experience, we estimate
between 10,000 and 15,000 (i.e., 12,500)
total annual responses for
nonprescription drugs marketed without
an approved application.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Reports of Serious Adverse Drug Events (21 U.S.C.
379aa(b) and (c)) .............................................................
50
250
12,500
2
25,000
Total ..............................................................................
........................
........................
........................
........................
25,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) (21 U.S.C. 379aa(e)) of
the FD&C Act also requires that
responsible persons maintain records of
nonprescription adverse event reports,
whether or not the event is serious, for
a period of 6 years. The guidance
recommends that responsible persons
maintain records of efforts to obtain the
minimum data elements for a report of
a serious adverse drug event and any
followup reports. Although the
guidance does not provide
recommendations on recordkeeping
activities generally under section 760(e)
of the FD&C Act, FDA is providing an
estimate for the burden of this
collection. Historically, serious adverse
event reports comprise approximately
two-thirds and nonserious adverse event
reports comprise approximately one-
third of the total number of
postmarketing adverse event reports
associated with drugs and biologic
therapeutics (except vaccines) received
by FDA. Based on this generalization,
FDA estimates the total annual records
to be approximately 20,000 records per
year. FDA estimates that it takes 5 hours
to maintain each record and the
recordkeeping burden as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
200
100
20,000
5
100,000
Total ..............................................................................
........................
........................
........................
........................
100,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Therefore, the estimated annual
reporting burden for this information is
25,000 hours and the estimated annual
recordkeeping burden is 100,000 hours.
Dated: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
sroberts on DSK5SPTVN1PROD with NOTICES
[FR Doc. 2011–33140 Filed 12–23–11; 8:45 am]
BILLING CODE 4160–01–P
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2011–D–0787]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Investigational Device Exemptions for
Early Feasibility Medical Device
Clinical Studies, Including Certain First
in Human Studies; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
22:00 Dec 23, 2011
Jkt 226001
Notice; extension of comment
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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period.
The Food and Drug
Administration (FDA) is extending the
comment period for the notice that
appeared in the Federal Register of
Thursday, November, 10, 2011 (76 FR
70150). In the notice, FDA requested
comments on the draft guidance that
addresses the approaches FDA intends
to facilitate early feasibility studies of
medical devices, using appropriate risk
mitigation strategies, under the
investigational device exemption (IDE)
requirements. The Agency is taking this
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]]>Agencies
[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80946-80947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33140]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0915]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Postmarketing Adverse Event
Reporting for Nonprescription Human Drug Products Marketed Without an
Approved Application
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 the FDA guidance for industry
on ``Postmarketing Adverse Event Reporting for Nonprescription Human
Drug Products Marketed Without an Approved Application.'' This guidance
document provides recommendations on postmarketing serious adverse
event reporting for nonprescription (over-the-counter) human drugs
marketed without an approved application. It provides recommendations
on the minimum data elements that should be included in a serious
adverse event report, the label that should be included with the
report, reporting formats for paper and electronic submissions, and how
and where to submit the reports.
DATES: Submit either electronic or written comments on the collection
of information by February 27, 2012.
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 docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.
PI50-400B, Rockville, MD 20850, (301) 796-7651,
juanmanuel.vilela@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.
Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved
Application--(OMB Control Number 0910-0636)--Extension
Respondents to this collection of information are manufacturers,
packers, and distributors whose name (under
[[Page 80947]]
section 502(b)(1) (21 U.S.C. 352(b)(1)) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act)) appears on the label of a nonprescription drug
marketed in the United States.
FDA is requesting public comment on estimates of annual submissions
from these respondents, as required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Public Law 109-462) and
described in the guidance. This guidance document discusses what should
be included in a serious adverse drug event report submitted under
section 760(b)(1) (21 U.S.C. 379aa(b)(1)) of the FD&C Act, including
followup reports under 760(c)(2) (21 U.S.C. 379aa(c)(2)) of the FD&C
Act, and how to submit these reports. The estimates for annual
reporting burden and recordkeeping are based on FDA's knowledge of
adverse drug experience reports historically submitted per year for
prescription drug products and for nonprescription drug products
marketed under an approved application, including knowledge about the
time needed to prepare the reports and to maintain records.
FDA receives approximately 2,500 serious adverse event reports for
nonprescription drug products marketed under approved applications,
which comprise approximately 20 percent of the overall nonprescription
drug market. Based on this experience, we estimate between 10,000 and
15,000 (i.e., 12,500) total annual responses for nonprescription drugs
marketed without an approved application.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Reports of Serious Adverse Drug 50 250 12,500 2 25,000
Events (21 U.S.C. 379aa(b) and
(c))...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 25,000
----------------------------------------------------------------------------------------------------------------
[sup1] There are no capital costs or operating and maintenance costs associated with this collection of
information.
Section 760(e) (21 U.S.C. 379aa(e)) of the FD&C Act also requires
that responsible persons maintain records of nonprescription adverse
event reports, whether or not the event is serious, for a period of 6
years. The guidance recommends that responsible persons maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any followup reports. Although the
guidance does not provide recommendations on recordkeeping activities
generally under section 760(e) of the FD&C Act, FDA is providing an
estimate for the burden of this collection. Historically, serious
adverse event reports comprise approximately two-thirds and nonserious
adverse event reports comprise approximately one-third of the total
number of postmarketing adverse event reports associated with drugs and
biologic therapeutics (except vaccines) received by FDA. Based on this
generalization, FDA estimates the total annual records to be
approximately 20,000 records per year. FDA estimates that it takes 5
hours to maintain each record and the recordkeeping burden as follows:
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
Activity recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 200 100 20,000 5 100,000
379aa(e)(1))...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 100,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Therefore, the estimated annual reporting burden for this
information is 25,000 hours and the estimated annual recordkeeping
burden is 100,000 hours.
Dated: December 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33140 Filed 12-23-11; 8:45 am]
BILLING CODE 4160-01-P
