Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application, 53251-53252 [E8-21345]
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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices
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[FR Doc. E8–21447 Filed 9–12–08; 8:45 am]
BILLING CODE 6345–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0434] (formerly
Docket No. 2007D–0386)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
mstockstill on PROD1PC66 with NOTICES
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 October 15,
2008.
ADDRESSES: To ensure that comments on
the information collection are received,
VerDate Aug<31>2005
20:22 Sep 12, 2008
Jkt 214001
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–NEW and title
‘‘Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application.’’ Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application
Public Law 109–462, the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act, amended the
Federal Food, Drug, and Cosmetic Act
(the act) to add safety reporting
requirements for nonprescription drug
products that are marketed without an
approved application. In accordance
with section 760(b) of the act (21 U.S.C.
379aa), the manufacturer, packer, or
distributor whose name appears on the
label of a nonprescription drug
marketed in the United States without
an approved application (referred to as
the responsible person) must submit to
FDA any report of a serious adverse
event associated with such drug when
used in the United States, accompanied
by a copy of the label on or within the
retail package of such drug. In addition,
the responsible person must submit
followup reports of new medical
information related to a submitted
serious adverse event report that is
received within 1 year of the initial
report (section 760(c)(2) of the act).
Section 760(e) of the act also requires
that responsible persons maintain
records of nonprescription drug adverse
event reports, whether or not the event
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
53251
is serious, for a period of 6 years. The
guidance document provides
information on: (1) The minimum data
elements that should be included in a
serious adverse event report, (2) the
label that should be included with the
report, (3) reporting formats for paper
and electronic submissions, and (4) how
and where to submit the reports.
Title: Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
or distributors whose name appears on
the label of a nonprescription drug
marketed in the United States without
an approved application.
Burden Estimate: FDA is requesting
public comment on estimates of the
number of annual submissions from
these respondents and recordkeeping, as
required by Public Law 109–462 and
described in the guidance
‘‘Postmarketing Adverse Event
Reporting for Nonprescription Human
Drug Products Marketed Without an
Approved Application.’’ The estimates
for annual reporting and recordkeeping
are based on FDA’s knowledge of
adverse drug experience reports
historically submitted annually 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 data, we estimate between
10,000 and 15,000 (i.e., 12,500) total
annual responses from approximately
50 respondents for nonprescription
drugs marketed without an approved
application, and that each submission
will take approximately 2 hours to
prepare and submit to FDA.
In the Federal Register of October 15,
2007 (72 FR 58316), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received
on the information collection.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15SEN1.SGM
15SEN1
53252
Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Reports of serious adverse drug events (21
U.S.C. 379aa((b) and (c))
Annual
Frequency per
Response
50
Total Annual
Responses
250
Hours Per
Response
12,500
Total Hours
2
Total
25,000
25,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The guidance also 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
document does not provide
recommendations on all the
recordkeeping activities required under
section 760(e) of the act, we are
providing an estimate for this burden.
Historically, serious adverse event
reports comprise approximately twothirds, and nonserious adverse event
reports comprise approximately onethird, of the total number of
postmarketing adverse event reports
associated with drugs and biologic
therapeutics (except vaccines) received
by FDA. Based on this generalization,
we estimate the total annual records to
be approximately 20,000 records per
year, and the number of respondents to
be approximately 200. We also estimate
that it takes approximately 5 hours to
maintain each record.
TABLE 2.— ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Annual
Frequency per
Recordkeeping
200
100
Recordkeeping (21 U.S.C. 379aa(e)(1))
Total Annual
Records
Hours Per
Record
20,000
Total
100,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Therefore, the estimated annual
reporting burden for this information
collection is 25,000 hours and the
estimated annual recordkeeping burden
is 100,000 hours.
Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21345 Filed 9–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0372] (formerly
Docket No. 2007D–0388)
mstockstill on PROD1PC66 with NOTICES
5
100,000
1 There
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Reporting and Recordkeeping for
Dietary Supplements as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Total Hours
Notice.
VerDate Aug<31>2005
20:22 Sep 12, 2008
Jkt 214001
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 October 15,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–NEW and title,
‘‘Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act.’’ 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 (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
has submitted the following proposed
collection of information to OMB for
review and clearance.
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act—(OMB Control Number
0910–NEW)
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors of dietary supplements
marketed in the United States.
On December 22, 2006, the President
signed into law the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act (DSNDCPA) (Public Law
109–462, 120 Stat. 3469). This law
amends the Federal Food, Drug, and
Cosmetic Act (the act) with respect to
serious adverse event reporting and
recordkeeping for dietary supplements
and non-prescription drugs marketed
without an approved application.
Under section 761(b)(1) of the act (21
U.S.C. 379aa–1(b)(1)), the manufacturer,
packer, or distributor whose name
(under section 403(e)(1) of the act (21
U.S.C. 343(e)(1))) appears on the label of
a dietary supplement marketed in the
United States is required to submit to
FDA any serious adverse event report it
receives regarding use of the dietary
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53251-53252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21345]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0434] (formerly Docket No. 2007D-0386)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 October
15, 2008.
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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-NEW and title
``Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved
Application.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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.
Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved
Application
Public Law 109-462, the Dietary Supplement and Nonprescription Drug
Consumer Protection Act, amended the Federal Food, Drug, and Cosmetic
Act (the act) to add safety reporting requirements for nonprescription
drug products that are marketed without an approved application. In
accordance with section 760(b) of the act (21 U.S.C. 379aa), the
manufacturer, packer, or distributor whose name appears on the label of
a nonprescription drug marketed in the United States without an
approved application (referred to as the responsible person) must
submit to FDA any report of a serious adverse event associated with
such drug when used in the United States, accompanied by a copy of the
label on or within the retail package of such drug. In addition, the
responsible person must submit followup reports of new medical
information related to a submitted serious adverse event report that is
received within 1 year of the initial report (section 760(c)(2) of the
act). Section 760(e) of the act also requires that responsible persons
maintain records of nonprescription drug adverse event reports, whether
or not the event is serious, for a period of 6 years. The guidance
document provides information on: (1) The minimum data elements that
should be included in a serious adverse event report, (2) the label
that should be included with the report, (3) reporting formats for
paper and electronic submissions, and (4) how and where to submit the
reports.
Title: Guidance for Industry on Postmarketing Adverse Event
Reporting for Nonprescription Human Drug Products Marketed Without an
Approved Application.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, or distributors whose name
appears on the label of a nonprescription drug marketed in the United
States without an approved application.
Burden Estimate: FDA is requesting public comment on estimates of
the number of annual submissions from these respondents and
recordkeeping, as required by Public Law 109-462 and described in the
guidance ``Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application.'' The
estimates for annual reporting and recordkeeping are based on FDA's
knowledge of adverse drug experience reports historically submitted
annually 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 data, we estimate between 10,000 and 15,000
(i.e., 12,500) total annual responses from approximately 50 respondents
for nonprescription drugs marketed without an approved application, and
that each submission will take approximately 2 hours to prepare and
submit to FDA.
In the Federal Register of October 15, 2007 (72 FR 58316), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received on the information
collection.
FDA estimates the burden of this collection of information as
follows:
[[Page 53252]]
Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency per Total Annual Hours Per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
Reports of serious adverse 50 250 12,500 2 25,000
drug events (21 U.S.C.
379aa((b) and (c))
----------------------------------------------------------------------------------------------------------------
Total 25,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The guidance also 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 document does not provide recommendations on all the
recordkeeping activities required under section 760(e) of the act, we
are providing an estimate for this burden. 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, we estimate the total annual records to be
approximately 20,000 records per year, and the number of respondents to
be approximately 200. We also estimate that it takes approximately 5
hours to maintain each record.
Table 2.-- Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
No. of Frequency per Total Annual Hours Per Total Hours
Recordkeepers Recordkeeping Records Record
----------------------------------------------------------------------------------------------------------------
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 collection is 25,000 hours and the estimated annual
recordkeeping burden is 100,000 hours.
Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21345 Filed 9-12-08; 8:45 am]
BILLING CODE 4160-01-S
