Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting and Recordkeeping Biological Products, 35957-35958 [2015-15319]
Download as PDF
<![CDATA[
35957
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
information. Two comments were
received but neither responded to any of
the four information collection topics
solicited and are therefore not addressed
by the Agency.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
511.1(b)(4) .......................................................
511.1(b)(5) .......................................................
511.1(b)(6) .......................................................
511.1(b)(8)(ii) ...................................................
511.1(b)(9) .......................................................
263
263
263
263
263
5.30
.26
.01
.06
.06
1,395
69
2
15
15
1
8
1
2
8
1,395
552
2
30
120
Total ..........................................................
............................
............................
............................
............................
2,099
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of records
per
recordkeeper
Total annual
records
Average burden
per
recordkeeping
Total hours
511.1(a)(3) .................................................
511.1(b)(3) .................................................
511.1(b)(7)(ii) .............................................
511.1(b)(8)(i) ..............................................
263
263
263
263
2.07
5.30
5.30
5.30
545
1,395
1,395
1,395
1
1
3.5
3.5
545
1,395
4,882.5
4,882.5
Total ....................................................
..............................
..............................
............................
..............................
11,705
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
reporting requirements, record
preparation, and maintenance for this
collection of information is based on
informal Agency communication with
industry. Based on the number of
sponsors subject to animal drug user
fees, FDA estimates that there are 263
respondents. We use this estimate
consistently throughout the table and
calculate the ‘‘annual frequency per
respondent’’ by dividing the total
annual responses by number of
respondents. Additional information
needed to make a final calculation of the
total burden hours (i.e., the number of
respondents, the number of
recordkeepers, the number of NCIEs
received, etc.) is derived from Agency
records.
Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15320 Filed 6–22–15; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
and Recordkeeping Biological
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 July 22,
2015.
SUMMARY:
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
ADDRESSES:
VerDate Sep<11>2014
18:39 Jun 22, 2015
Jkt 235001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
comments should be identified with the
OMB control number 0910–0230. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Postmarketing Adverse Drug
Experience Reporting
OMB Control Number 0910–0230—
(Extension)
Sections 201, 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic 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
associated with 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
E:\FR\FM\23JNN1.SGM
23JNN1
35958
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Notices
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
(‘‘15-day Alert reports’’), as well as
follow up reports (§ 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 nonapplicants.
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, an
analysis of the 15-day Alert reports
submitted during the reporting interval,
and a history of actions taken because
of adverse drug experiences. Under
§ 314.80(i), applicants must keep for 10
years records of all adverse drug
experience reports known to the
applicant.
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 follow-up reports
(§ 310.305(c)). Section 310.305(c)(5)
pertains to the submission of follow-up
reports to reports forwarded to the
manufacturers, packers, and distributors
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 enable identification of
signals 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 longterm 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.
In the Federal Register of March 12,
2015 (80 FR 13009), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
No. of
respondents
21 CFR section
No. of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
310.305(c)(5) ..............................................
314.80(c)(1)(iii) ...........................................
314.80(c)(2) ................................................
3
5
724
1
1
19.33
3
5
13,996
1
1
60
3
5
839,760
Total ....................................................
..............................
..............................
............................
..............................
839,768
1 The
reporting burden for § 310.305(c)(1), (c)(2), and (c)(3), and § 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910–0291.
2 The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
No. of
recordkeepers
21 CFR section
No. of records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
310.305(f) ...................................................
314.80(i) .....................................................
25
724
1
508
25
367,959
16
16
400
5,887,344
Total ....................................................
..............................
..............................
............................
..............................
5,887,744
1 There
2 There
are no capital costs or operating costs associated with this collection of information.
are maintenance costs of approximately $22,000 annually.
Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2015–15319 Filed 6–22–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:39 Jun 22, 2015
Jkt 235001
PO 00000
Frm 00027
Fmt 4703
Sfmt 9990
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35957-35958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0253]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Drug Experience Reporting and Recordkeeping Biological Products
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 July
22, 2015.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0230.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Postmarketing Adverse Drug Experience Reporting
OMB Control Number 0910-0230--(Extension)
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic 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 associated with 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
[[Page 35958]]
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 (``15-day Alert reports''), as well as follow up reports
(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, an analysis of the 15-day Alert reports submitted during
the reporting interval, and a history of actions taken because of
adverse drug experiences. Under Sec. 314.80(i), applicants must keep
for 10 years records of all adverse drug experience reports known to
the applicant.
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 follow-up reports (Sec.
310.305(c)). Section 310.305(c)(5) pertains to the submission of
follow-up reports to reports forwarded to the manufacturers, packers,
and distributors 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 enable identification of signals 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.
In the Federal Register of March 12, 2015 (80 FR 13009), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of responses Total annual Average burden
21 CFR section respondents per respondent responses per response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(c)(5).............................................. 3 1 3 1 3
314.80(c)(1)(iii).......................................... 5 1 5 1 5
314.80(c)(2)............................................... 724 19.33 13,996 60 839,760
--------------------------------------------------------------------------------------------
Total.................................................. ................. ................. ................ ................. 839,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec. 310.305(c)(1), (c)(2), and (c)(3), and Sec. 314.80(c)(1)(i) and (c)(1)(ii) is covered under OMB Control No. 0910-
0291.
\2\ The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of records Total annual Average burden
21 CFR section recordkeepers per recordkeeper records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
310.305(f)................................................. 25 1 25 16 400
314.80(i).................................................. 724 508 367,959 16 5,887,344
--------------------------------------------------------------------------------------------
Total.................................................. ................. ................. ................ ................. 5,887,744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.
Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15319 Filed 6-22-15; 8:45 am]
BILLING CODE 4164-01-P
