Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting, 76358-76360 [E8-29664]
Download as PDF
<![CDATA[
76358
Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices
available to a person with such a disease
or condition unless an exemption is
granted, because there is no comparable
device other than another HUD
approved under this exemption that is
available to treat or diagnose the disease
or condition; and (3) will not expose
patients to an unreasonable or
significant risk of illness or injury with
the probable benefit to health from
using the device outweighing the risk of
injury or illness from its use. This takes
into account the probable risks and
benefits of currently available devices or
alternative forms of treatment.
The information collected will assist
FDA in making determinations on the
following: (1) Whether to grant HUD
designation of a medical device; (2)
exempt a HUD from the effectiveness
requirements under sections 514 and
515 of the act, provided that the device
meets requirements set forth under
section 520(m) of the act; and (3)
whether to grant marketing approval(s)
for the HUD. Failure to collect this
information would prevent FDA from
making a determination on the factors
listed previously in this document.
Further, the collected information
would also enable FDA to determine
whether the holder of a HUD is in
compliance with the HUD provisions
under section 520(m) of the act.
In the Federal Register of October 1,
2008 (73 FR 57108), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
814.102
14
1
14
40
560
814.104
6
1
6
320
1,920
814.106
6
2
12
50
600
814.108
32
1
32
80
2,560
814.116(e)(3)
1
1
1
1
1
814.124(a)
5
1
5
1
5
814.124(b)
4
1
4
2
8
45
1
45
120
5,400
814.126(b)(1)
Total
1 There
11,054
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
814.126(b)(2)
Annual Frequency
per Recordkeeping
45
Total Annual
Records
1
Hours Per
Record
45
Total Hours
2
Total
1 There
90
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in tables
1 and 2 of this document are an average
from data for the previous 3 years, i.e.,
fiscal year 2005–2007. The number of
annual reports submitted under
§ 814.126(b)(1) in table 1 reflects an
increase to 45 respondents with
approved HUD applications. Likewise,
under § 814.126(b)(2) in table 2, the
number of recordkeepers increased to
45.
sroberts on PROD1PC70 with NOTICES
90
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29672 Filed 12–15–08; 8:45 am]
HHS.
BILLING CODE 4160–01–S
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2008–N–0633]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
AGENCY:
ACTION:
Food and Drug Administration,
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
postmarketing adverse drug experience
reporting and recordkeeping
requirements.
DATES: Submit written or electronic
comments on the collection of
information by February 17, 2009.
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
E:\FR\FM\16DEN1.SGM
16DEN1
76359
Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices
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:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
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.
Postmarketing Adverse Drug
Experience Reporting—21 CFR 310.305
and 314.80 (OMB Control Number
0910–0230)—Extension
Sections 201, 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 321, 352, 355, and
371) require that marketed drugs be safe
and effective. In order to know whether
drugs that are not safe and effective are
on the market, FDA must be promptly
informed of adverse experiences
occasioned by the use of marketed
drugs. In order to help ensure this, FDA
issued regulations at §§ 310.305 and
314.80 (21 CFR 310.305 and 314.80) to
impose reporting and recordkeeping
requirements on the drug industry that
would enable FDA to take the action
necessary to protect the public health
from adverse drug experiences.
All applicants who have received
marketing approval of drug products are
required to report to FDA serious,
unexpected adverse drug experiences,
as well as followup reports when
needed (§ 314.80(c)(1)). This includes
reports of all foreign or domestic
adverse experiences as well as those
based on information from applicable
scientific literature and certain reports
from postmarketing studies. Section
314.80(c)(1)(iii) pertains to such reports
submitted by non-applicants. Under
§ 314.80(c)(2), applicants must provide
periodic reports of adverse drug
experiences. A periodic report includes,
for the reporting interval, reports of
serious, expected adverse drug
experiences and all nonserious adverse
drug experiences and an index of these
reports, a narrative summary and
analysis of adverse drug experiences
and a history of actions taken because
of adverse drug experiences. Under
§ 314.80(i), applicants must keep
records of all adverse drug experience
reports known to the applicant for 10
years.
For marketed prescription drug
products without approved new drug
applications or abbreviated new drug
applications, manufacturers, packers,
and distributors are required to report to
FDA serious, unexpected adverse drug
experiences as well as followup reports
when needed (§ 310.305(c)). Section
310.305(c)(5) pertains to the submission
of followup reports to reports forwarded
by FDA. Under § 310.305(f), each
manufacturer, packer, and distributor
shall maintain for 10 years records of all
adverse drug experiences required to be
reported.
The primary purpose of FDA’s
adverse drug experience reporting
system is to provide a signal for
potentially serious safety problems with
marketed drugs. Although premarket
testing discloses a general safety profile
of a new drug’s comparatively common
adverse effects, the larger and more
diverse patient populations exposed to
the marketed drug provide the
opportunity to collect information on
rare, latent, and long-term effects.
Signals are obtained from a variety of
sources, including reports from patients,
treating physicians, foreign regulatory
agencies, and clinical investigators.
Information derived from the adverse
drug experience reporting system
contributes directly to increased public
health protection because the
information enables FDA to make
important changes to the product’s
labeling (such as adding a new
warning), decisions about risk
evaluation and mitigation strategies or
the need for postmarket studies or
clinical trials, and when necessary, to
initiate removal of a drug from the
market.
Respondents to this collection of
information are manufacturers, packers,
distributors, and applicants. FDA
estimates the burden of this collection
of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
310.305(c)(5)
1
1
1
1
1
314.80(c)(1)(iii)
5
1
5
1
5
642
17.88
11,478
60
688,680
sroberts on PROD1PC70 with NOTICES
314.80(c)(2)
Total
688,686
1 The
reporting burden for §§ 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB No. 0910–0291. The
capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
E:\FR\FM\16DEN1.SGM
16DEN1
76360
Federal Register / Vol. 73, No. 242 / Tuesday, December 16, 2008 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency per
Recordkeeping
Total Annual
Records
Hours per Record
Total Hours
310.305(f)
25
1
25
16
400
314.80(i)
642
623
400,000
16
6,400,000
Total
7,088,680
1There
are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.
These estimates are based on FDA’s
knowledge of adverse drug experience
reporting, including the time needed to
prepare the reports, and the number of
reports submitted to the agency.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29664 Filed 12–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0490]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary
Cosmetic Registration Program
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 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 January 15,
2009.
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
VerDate Aug<31>2005
17:09 Dec 15, 2008
Jkt 217001
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0030. 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
has submitted the following proposed
collection of information to OMB for
review and clearance.
Voluntary Cosmetic Registration
Program—(OMB Control Number 0910–
0030)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act) provides FDA with the
authority to regulate cosmetic products
in the United States. Cosmetic products
that are adulterated under section 601 of
the act (21 U.S.C. 361) or misbranded
under section 602 of the act (21 U.S.C.
362) may not be distributed in interstate
commerce. To assist FDA in carrying
out its responsibility to regulate
cosmetics, the agency has developed the
Voluntary Cosmetic Registration
Program (VCRP). In part 720 (21 CFR
part 720), FDA requests that firms that
manufacture, pack, or distribute
cosmetics file with the agency an
ingredient statement for each of their
products. Ingredient statements for new
submissions (§§ 720.1 through 720.4)
are reported on Form FDA 2512,
‘‘Cosmetic Product Ingredient
Statement,’’ and on Form FDA 2512a, a
continuation form. Amendments to
product formulations (§§ 720.3, 720.4,
and 720.6) also are reported on Forms
FDA 2512 and FDA 2512a. When a firm
discontinues the commercial
distribution of a cosmetic, FDA requests
that the firm file Form FDA 2514,
‘‘Discontinuance of Commercial
Distribution of Cosmetic Product
Formulation’’ (§§ 720.3 and 720.6). If
any of the information submitted on or
with these forms is confidential, the
firm may submit a request for
confidentiality under § 720.8.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
FDA’s online filing system, intended
to make it easier to participate in the
VCRP, was made available industrywide on December 1, 2005. The online
filing system is available on FDA’s
VCRP Web site at https://
www.cfsan.fda.gov/~dms/cosregn.html. The online filing system
contains the electronic versions of
Forms FDA 2512, 2512a, and 2514,
which are collectively found within the
electronic version of Form FDA 2512.
The agency strongly encourages
electronic filing of Form FDA 2512
because it is faster and more convenient.
A filing facility will receive
confirmation of electronic filing by email. Submission of the paper version of
Forms FDA 2512, 2512a, and 2514
remains an option as described in
https://www.cfsan.fda.gov/~dms/cosreg2.html. However, due to the high
volume of online participation, the
VCRP is allocating its limited resources
primarily to electronic filings.
FDA places cosmetic product filing
information in a computer data base and
uses the information for evaluation of
cosmetic products currently on the
market. Because filing of cosmetic
product formulations is not mandatory,
voluntary filings provide FDA with the
best information available about
cosmetic product ingredients and their
frequency of use, businesses engaged in
the manufacture and distribution of
cosmetics, and approximate rates of
product discontinuance and formula
modifications. The information assists
FDA scientists in evaluating reports of
alleged injuries and adverse reactions
from the use of cosmetics. The
information also is used in defining and
planning analytical and toxicological
studies pertaining to cosmetics.
Information from the database is
releasable to the public under FDA
compliance with the Freedom of
Information Act. FDA shares
nonconfidential information from its
files on cosmetics with consumers,
medical professionals, and industry.
In the Federal Register of September
17, 2008 (73 FR 53877), FDA published
a 60-day notice requesting public
comment on the information collection
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Pages 76358-76360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29664]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0633]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Drug Experience Reporting
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 postmarketing adverse drug
experience reporting and recordkeeping requirements.
DATES: Submit written or electronic comments on the collection of
information by February 17, 2009.
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
[[Page 76359]]
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: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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.
Postmarketing Adverse Drug Experience Reporting--21 CFR 310.305 and
314.80 (OMB Control Number 0910-0230)--Extension
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321, 352, 355, and 371) require that
marketed drugs be safe and effective. In order to know whether drugs
that are not safe and effective are on the market, FDA must be promptly
informed of adverse experiences occasioned by the use of marketed
drugs. In order to help ensure this, FDA issued regulations at
Sec. Sec. 310.305 and 314.80 (21 CFR 310.305 and 314.80) to impose
reporting and recordkeeping requirements on the drug industry that
would enable FDA to take the action necessary to protect the public
health from adverse drug experiences.
All applicants who have received marketing approval of drug
products are required to report to FDA serious, unexpected adverse drug
experiences, as well as followup reports when needed (Sec.
314.80(c)(1)). This includes reports of all foreign or domestic adverse
experiences as well as those based on information from applicable
scientific literature and certain reports from postmarketing studies.
Section 314.80(c)(1)(iii) pertains to such reports submitted by non-
applicants. Under Sec. 314.80(c)(2), applicants must provide periodic
reports of adverse drug experiences. A periodic report includes, for
the reporting interval, reports of serious, expected adverse drug
experiences and all nonserious adverse drug experiences and an index of
these reports, a narrative summary and analysis of adverse drug
experiences and a history of actions taken because of adverse drug
experiences. Under Sec. 314.80(i), applicants must keep records of all
adverse drug experience reports known to the applicant for 10 years.
For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as followup reports when
needed (Sec. 310.305(c)). Section 310.305(c)(5) pertains to the
submission of followup reports to reports forwarded by FDA. Under Sec.
310.305(f), each manufacturer, packer, and distributor shall maintain
for 10 years records of all adverse drug experiences required to be
reported.
The primary purpose of FDA's adverse drug experience reporting
system is to provide a signal for potentially serious safety problems
with marketed drugs. Although premarket testing discloses a general
safety profile of a new drug's comparatively common adverse effects,
the larger and more diverse patient populations exposed to the marketed
drug provide the opportunity to collect information on rare, latent,
and long-term effects. Signals are obtained from a variety of sources,
including reports from patients, treating physicians, foreign
regulatory agencies, and clinical investigators. Information derived
from the adverse drug experience reporting system contributes directly
to increased public health protection because the information enables
FDA to make important changes to the product's labeling (such as adding
a new warning), decisions about risk evaluation and mitigation
strategies or the need for postmarket studies or clinical trials, and
when necessary, to initiate removal of a drug from the market.
Respondents to this collection of information are manufacturers,
packers, distributors, and applicants. FDA estimates the burden of this
collection of information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5) 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.80(c)(1)(iii) 5 1 5 1 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.80(c)(2) 642 17.88 11,478 60 688,680
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 688,686
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec. Sec. 310.305(c)(1), (c)(2), and (c)(3), and 314.80(c)(1)(i) and (c)(1)(ii) was reported under OMB No. 0910-0291.
The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
[[Page 76360]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f) 25 1 25 16 400
--------------------------------------------------------------------------------------------------------------------------------------------------------
314.80(i) 642 623 400,000 16 6,400,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 7,088,680
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.
These estimates are based on FDA's knowledge of adverse drug
experience reporting, including the time needed to prepare the reports,
and the number of reports submitted to the agency.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29664 Filed 12-15-08; 8:45 am]
BILLING CODE 4160-01-S
