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, 3608-3609 [2015-01111]
Download as PDF
<![CDATA[
3608
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices
Dated: January 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01113 Filed 1–22–15; 8:45 am]
BILLING CODE 4164–01–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:
Submit either electronic or
written comments on the collection of
information by March 24, 2015.
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: 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: 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
DATES:
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.
SUMMARY:
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
section 502(b)(1) (21 U.S.C. 352(b)(1)) of
the Federal Food, Drug, and Cosmetic
Act (the 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 (Pub. L. 109–462) and
described in the guidance. The 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 follow-up 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 the annual
reporting and recordkeeping burdens
are based on FDA data on the number
of adverse drug experience reports
submitted for nonprescription drug
products marketed without an approved
application, including FDA’s knowledge
about the time needed to prepare the
reports and to maintain records.
Based on FDA data, we estimate
between 10,000 and 15,000 (i.e.,
approximately 12,500) total annual
responses from approximately 50
respondents for nonprescription drugs
marketed without an approved
application, and we also estimate that
each submission will take
approximately 2 hours to prepare and
submit.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
tkelley on DSK3SPTVN1PROD with NOTICES
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
Total hours
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
50
250
12,500
2
25,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
18:05 Jan 22, 2015
Jkt 235001
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
E:\FR\FM\23JAN1.SGM
23JAN1
3609
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices
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
document recommends that
respondents maintain records of efforts
to obtain the minimum data elements
for a report of a serious adverse drug
event and any follow-up reports. We
estimate that there are approximately
20,000 records per year maintained by
approximately 200 respondents, and
that it takes approximately 5 hours to
maintain each record.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
200
100
20,000
5
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: January 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–01111 Filed 1–22–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Science Board to the Food
and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for members to serve on
the Science Board to the Food and Drug
Administration, Office of the
Commissioner, Office of the Chief
Scientist. FDA seeks to include the
views of women and men, members of
all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before March 24, 2015 will be given first
consideration for membership on the
Science Board to the Food and Drug
Administration. Nominations received
after March 24, 2015 will be considered
for nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:05 Jan 22, 2015
Jkt 235001
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Martha Monser, Office of the Chief
Scientist, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring,
MD 20993–0002, 301–796–4627,
martha.monser@fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site by using the following link:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
members on the Science Board to the
Food and Drug Administration.
I. General Description of the Committee
Duties
The Science Board shall provide
advice to the Commissioner and other
appropriate officials on specific
complex scientific and technical issues
important to FDA and its mission,
including emerging issues within the
scientific community. Additionally, the
Science Board will provide advice that
supports the Agency in keeping pace
with technical and scientific
developments, including in regulatory
science, provide input into the Agency’s
research agenda, and on upgrading its
scientific and research facilities and
training opportunities. It will also
provide, where requested, expert review
of Agency sponsored intramural and
extramural scientific research programs.
II. Criteria for Voting Members
The committee consists of a core of 21
voting members including the chair and
a co-chair. Members, the chair and the
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
co-chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of: Food science, safety, and nutrition;
chemistry, pharmacology, translational
and clinical medicine and research,
toxicology, biostatistics, medical
devices, imaging, robotics, cell and
tissue based products, regenerative
medicine, public health and
epidemiology, international health and
regulation, product safety, product
manufacturing sciences and quality; and
other scientific areas relevant to FDA
regulated products such as systems
biology, informatics, nanotechnology,
and combination products. Almost all
non-Federal members of this committee
serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
specify the advisory committee for
which the nominee recommended.
Nominations must also acknowledge
that the nominee is aware of the
nomination unless self-nominated. FDA
will ask potential candidates to provide
detailed information concerning such
matters related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3608-3609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01111]
-----------------------------------------------------------------------
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 March 24, 2015.
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: 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: 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 section 502(b)(1) (21
U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (the 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 (Pub. L.
109-462) and described in the guidance. The 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 follow-up 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 the annual reporting and recordkeeping burdens are based
on FDA data on the number of adverse drug experience reports submitted
for nonprescription drug products marketed without an approved
application, including FDA's knowledge about the time needed to prepare
the reports and to maintain records.
Based on FDA data, we estimate between 10,000 and 15,000 (i.e.,
approximately 12,500) total annual responses from approximately 50
respondents for nonprescription drugs marketed without an approved
application, and we also estimate that each submission will take
approximately 2 hours to prepare and submit.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and 50 250 12,500 2 25,000
(c))..............................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 3609]]
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 document recommends that respondents maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any follow-up reports. We estimate
that there are approximately 20,000 records per year maintained by
approximately 200 respondents, and that it takes approximately 5 hours
to maintain each record.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 379aa(e)(1)).............................. 200 100 20,000 5 100,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: January 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01111 Filed 1-22-15; 8:45 am]
BILLING CODE 4164-01-P
