Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug Experience Reporting, 10924-10926 [E9-5494]
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10924
Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices
Estimated state
median income for
a four-person
family1
States
60 Percent of estimated state median income for a
four-person
family 2 3
66,939
62,353
69,854
68,646
88,625
97,326
53,041
78,061
64,591
67,183
71,063
57,247
67,605
75,161
83,241
61,494
64,930
61,581
62,358
65,460
73,550
81,919
77,676
56,430
75,111
72,788
40,163
37,412
41,912
41,188
53,175
58,396
31,825
46,837
38,755
40,310
42,638
34,348
40,563
45,097
49,945
36,896
38,958
36,949
37,415
39,276
44,130
49,151
46,606
33,858
45,067
43,673
Missouri ........................................................................................................................................................
Montana .......................................................................................................................................................
Nebraska ......................................................................................................................................................
Nevada .........................................................................................................................................................
New Hampshire ...........................................................................................................................................
New Jersey ..................................................................................................................................................
New Mexico .................................................................................................................................................
New York .....................................................................................................................................................
North Carolina ..............................................................................................................................................
North Dakota ................................................................................................................................................
Ohio .............................................................................................................................................................
Oklahoma .....................................................................................................................................................
Oregon .........................................................................................................................................................
Pennsylvania ................................................................................................................................................
Rhode Island ................................................................................................................................................
South Carolina .............................................................................................................................................
South Dakota ...............................................................................................................................................
Tennessee ...................................................................................................................................................
Texas ...........................................................................................................................................................
Utah .............................................................................................................................................................
Vermont .......................................................................................................................................................
Virginia .........................................................................................................................................................
Washington ..................................................................................................................................................
West Virginia ................................................................................................................................................
Wisconsin .....................................................................................................................................................
Wyoming ......................................................................................................................................................
Note: FFY 2010 covers the period of October 1, 2009, through September 30, 2010. The estimated median income for a four-person family living in the United States for this period is $72,336. These estimates become effective for LIHEAP at any time between the date of this publication
and October 1, 2009, or the beginning of a LIHEAP grantee’s fiscal year, whichever is later.
1 Prepared by the U.S. Census Bureau, U.S. Department of Commerce (Census Bureau), from an average of data from the 2005, 2006 and
2007 American Community Surveys (ACSs). These estimates, like those derived from any survey, are subject to two types of errors: (1) Nonsampling Error, which consists of random errors that increase the variability of the data and non-random errors that consistently direct the data
into a specific direction; and (2) Sampling Error, which consists of the error that arises from the use of probability sampling to create the sample.
2 These figures were calculated by the U.S. Department of Health and Human Services, Administration for Children and Families, Office of
Community Services, Division of Energy Assistance (DEA) by multiplying the estimated State median income for a four-person family for each
State by 60 percent.
3 To adjust for different sizes of family, 45 CFR 96.85 calls for multiplying 60 percent of a State’s estimated median income for a four-person
family by the following percentages: 52 percent for one person, 68 percent for two persons, 84 percent for three persons, 100 percent for four
persons, 116 percent for five persons, and 132 percent for six persons. For each additional family member above six persons, 45 CFR 96.85
calls for adding 3 percentage points to the percentage for a six-person family (132 percent) and multiply the new percentage by 60 percent of a
State’s estimated median income for a four-person family.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 13,
2009.
[FR Doc. E9–5412 Filed 3–12–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2008–N–0633]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Adverse Drug Experience Reporting
AGENCY:
sroberts on PROD1PC70 with NOTICES
ACTION:
Food and Drug Administration,
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
SUMMARY:
VerDate Nov<24>2008
20:34 Mar 12, 2009
Jkt 217001
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
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.
Postmarketing Adverse Drug
Experience Reporting (OMB Control
Number 0910–0230—Extension)
ADDRESSES:
Food and Drug Administration
HHS.
SUPPLEMENTARY INFORMATION:
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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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
E:\FR\FM\13MRN1.SGM
13MRN1
10925
Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices
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.
In the Federal Register of December
16, 2008 (73 FR 76358), 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:
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
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 control no. 0910–
0291. The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
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
sroberts on PROD1PC70 with NOTICES
1There
7,088,680
are no capital costs or operating costs associated with this collection of information. There are maintenance costs of $22,000 annually.
VerDate Nov<24>2008
17:55 Mar 12, 2009
Jkt 217001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\13MRN1.SGM
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10926
Federal Register / Vol. 74, No. 48 / Friday, March 13, 2009 / Notices
Dated: March 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–5494 Filed 3–12–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA–2009–N–0667]
[FDA 225–07–8006]
Memorandum of Understanding With
Baylor College of Medicine, The
University of Texas M.D. Anderson
Cancer Center, Rice University,
University of Houston, The University
of Texas Health Science Center at
Houston, Texas A&M Health Science
Center, The University of Texas
Medical Branch at Galveston, and The
Methodist Hospital Research Institute
for the FDA-ANH Nanotechnology
Initiative
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
VerDate Nov<24>2008
17:55 Mar 12, 2009
Jkt 217001
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) with The
Alliance for NanoHealth (ANH), a
collaboration among: Baylor College of
Medicine, The University of Texas M.D.
Anderson Cancer Center, Rice
University, University of Houston, The
University of Texas Health Science
Center at Houston, Texas A&M Health
Science Center, The University of Texas
Medical Branch at Galveston, and The
Methodist Hospital Research Institute.
This MOU identifies the terms of
collaboration between FDA and ANH in
the area of nanotechnology. Specifically,
this MOU establishes the FDA-ANH
Nanotechnology Initiative (FANTI), a
public-private partnership dedicated to
the identification of scientific and
translational gaps in moving
nanoengineered medical products from
the preclinical stages of development
through clinical stages and then to
commercialization, all with immediate
benefit to public health. The activities
are aligned with the mutual interests
and respective missions of the Parties,
including the FDA’s Critical Path
Initiative which seeks to modernize the
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
product development and regulatory
sciences needed to reduce uncertainties
about product performance throughout
the product life cycle. Thus, a key goal
for the Parties is to improve the safety
and efficacy of nanoengineered products
and speed their delivery to the patients
who need them and the consumers who
use them.
DATES: The agreement became effective
February 11, 2009.
FOR FURTHER INFORMATION CONTACT:
Wendy R. Sanhai, Office of the
Commissioner (HZ–1), Food and Drug
Administration, 5600 Fishers Lane,
suite 6A–08, Rockville, MD 20857, 301–
827–7867.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: March 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
BILLING CODE 4160–01–S
E:\FR\FM\13MRN1.SGM
13MRN1
]]>Agencies
[Federal Register Volume 74, Number 48 (Friday, March 13, 2009)]
[Notices]
[Pages 10924-10926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5494]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0633]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Drug Experience Reporting
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 April
13, 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 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: 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.
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 (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
[[Page 10925]]
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.
In the Federal Register of December 16, 2008 (73 FR 76358), 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:
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 control no. 0910-
0291. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[[Page 10926]]
Dated: March 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5494 Filed 3-12-09; 8:45 am]
BILLING CODE 4160-01-S
