30 Day Federal Register Notice

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Federal Register / Vol. 74, No. 223 / Friday, November 20, 2009 / Notices
ESTIMATED ONE-YEAR ANNUALIZED BURDEN TABLE

Screener ...............................................................
Focus group discussion guide and mini-questionnaire.

Adults ............................
Adolescents ages 13–
15.

2,000
160

1
1

3/60
2

100
320

Total ...............................................................

.......................................

2,160

........................

........................

420

BILLING CODE 4150–30–P

Indian Health Service

Indian Health Service, HHS.
Request for Public Comment:
30-day Proposed Information Collection:
Indian Health Service Forms to
Implement the Privacy Rule (45 CFR
parts 160 & 164).
AGENCY:

Delegation of Authority

ACTION:

Notice is hereby given that I have
delegated to the Assistant Secretary for
Aging the authorities vested in the
Secretary of Health and Human Services
under Section 1701(a)(3)(A–B), Section
1701(a)(4), and Section 1703(a)(4) of the
Public Health Service Act (42 U.S.C.
300u(a)(3)(A–B), 300u(a)(4), and 300u–
2(a), as amended), as they pertain to the
exercise of the funds transferred by the
Secretary to the Administration on
Aging under the ‘‘Prevention and
Wellness Fund’’ of the American
Recovery and Reinvestment Act of 2009,
Public Law 111–5 (Feb. 17, 2009) to
carry out evidence-based clinical and
community-based prevention and
wellness strategies through chronic
disease self-management programs
targeted to improving the health of
seniors under the ‘‘Communities Putting
Prevention to Work’’ initiative.
These authorities may be redelegated.
Exercise of these authorities is
concurrent to and does not supplant
existing delegations of authority from
the Secretary. Exercise of these
authorities shall be in accordance with
established policies, procedures,
guidelines, and regulations as
prescribed by the Secretary.
I hereby affirm and ratify any actions
taken by the Assistant Secretary for
Aging or his or her subordinates, which
involved the exercise of the authorities
delegated herein prior to the effective
date of this delegation. This delegation
is effective immediately.
Dated: November 12, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9–27863 Filed 11–19–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Request for Public Comment: 30-Day
Notice; Proposed Information
Collection: Indian Health Service
Forms

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Number of
respondents

Average
burden hours
per response

Type of respondent

Seleda M. Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E9–27881 Filed 11–19–09; 8:45 am]

srobinson on DSKHWCL6B1PROD with NOTICES

Number of
responses per
respondent

Forms
(if necessary)

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SUMMARY: The Indian Health Service
(IHS), as part of its continuing effort to
reduce paperwork and respondent
burden, conducts a pre-clearance
consultation program to provide the
general public and Federal agencies
with an opportunity to comment on
proposed and/or continuing collections
of information in accordance with the
Paperwork Reduction Act of 1995
(PRA95) (44 U.S.C. 3506(c)(2)(A)). This
program helps to ensure that requested
data can be provided in the desired
format, reporting burden (time and
financial resources) is minimized,
collection instruments are clearly
understood, and the impact of collection
requirements on respondents can be
properly assessed. As required by
section 3507(a)(1)(D) of the PRA95, the
proposed information collection has
been submitted to the Office of
Management and Budget (OMB) for
review and approval.
The IHS received no comments in
response to the 60-day Federal Register
notice (74 FR 30095) published on June
24, 2009. The purpose of this notice is
to allow an additional 30 days for public
comment to be submitted directly to
OMB.
Proposed Collection: Title: 0917–
0030, ‘‘Indian Health Service Forms to
Implement the Privacy Rule (45 CFR
parts 160 & 164)’’. Type of Information
Collection Request: Extension, with
revisions, of currently approved
information collection, 0917–0030,
‘‘Indian Health Service Forms to
Implement the Privacy Rule (45 CFR

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Total burden
hours

parts 160 & 164)’’. Form Number: IHS–
810, IHS–912–1, IHS–912–2, IHS–913,
and IHS–917. Need and Use of
Information Collection: The IHS will
use the following data collection
instructions to continue the
implementation of the information
collection requirements contained in the
Privacy Rule.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimate are logical; (e) ways to enhance
the quality, utility, and clarity of the
information being collected; and (f)
ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Send your
written comments and suggestions
regarding the proposed information
collection contained in this notice,
especially regarding the estimated
public burden and associated response
time, directly to: Office of Management
and Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Allison Eydt, Desk Officer for
IHS.
For Further Information: Send
requests for more information on the
proposed collection or to obtain a copy
of the data collection instrument(s) and
instructions to: Ms. Betty Gould, IHS
Reports Clearance Officer, 801
Thompson Avenue, TMP, Suite 450,
Rockville, MD 20852–1601, call non-toll
free (301) 443–7899, send via facsimile
to (301) 443–9879, or send your e-mail
requests, comments, and return address
to: [email protected].

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Federal Register / Vol. 74, No. 223 / Friday, November 20, 2009 / Notices
Comment Due Date: Your comments
regarding this information collection are
best assured of having full effect if
received within 30 days of the date of
this publication.
Dated: November 6, 2009.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. E9–27541 Filed 11–19–09; 8:45 am]
BILLING CODE 4165–16–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0556]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experience With
Approved New Animal Drugs;
Proposed New Data Elements for
Adverse Event Reports on Revised
Forms FDA 1932 and 1932a
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

srobinson on DSKHWCL6B1PROD with NOTICES

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 and to allow for public
comment in response to the notice. This
notice solicits comments on
requirements for recordkeeping and
reports concerning experience with
approved new animal drugs, specifically
on new data elements to be used in
revised versions of Forms FDA 1932 and
1932a. The information contained in the
reports required by this regulation
enables FDA to monitor the use of new
animal drugs after approval and to
ensure their continued safety and
efficacy.
DATES: Submit written or electronic
comments on the collection of
information by December 21, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to http://
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

VerDate Nov<24>2008

17:03 Nov 19, 2009

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docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION:
I. Background
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 notice in the
Federal Register concerning each
proposed 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.
II. Records and Reports Concerning
Experience With Approved New
Animal Drugs; Proposed New Data
Elements for Adverse Event Reports on
Revised Forms FDA 1932 and 1932a; 21
CFR 514.80 (OMB Control No. 0910–
0645)—Revision
Section 512(l) of the Federal Food,
Drug and Cosmetic Act (the act) (21
U.S.C. 360b(l)) and § 514.80(b) of FDA
regulations (21 CFR 514.80) require
applicants of approved new animal drug
applications (NADAs) and approved
abbreviated new animal drug
applications (ANADAs) to report
adverse drug experiences and product/
manufacturing defects.

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This continuous monitoring of
approved NADAs and ANADAs affords
the primary means by which FDA
obtains information regarding potential
problems with the safety and efficacy of
marketed approved new animal drugs as
well as potential product/manufacturing
problems. Postapproval marketing
surveillance is important because data
previously submitted to FDA may no
longer be adequate, as animal drug
effects can change over time and less
apparent effects may take years to
manifest.
An applicant must report adverse
drug experiences and product/
manufacturing defects on Form FDA
1932, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product
Defect Report.’’ Periodic drug
experience reports and special drug
experience reports must be
accompanied by a completed Form FDA
2301, ‘‘Transmittal of Periodic Reports
and Promotional Material for New
Animal Drugs’’ (see § 514.80(d)). Form
FDA 1932a, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness or
Product Defect Report,’’ allows for
voluntary reporting of adverse drug
experiences or product/manufacturing
defects.
Collection of information using
existing paper forms FDA 2301, 1932,
and 1932a is currently approved under
OMB control number 0910–0284, set to
expire on January 31, 2010. FDA
currently is seeking renewal of that
information collection.
FDA recently proposed to collect
information using electronic versions of
Forms FDA 1932 and 1932a as part of
the agency-wide information collection
(MedWatchPlus Portal and Rational
Questionnaire) that was announced for
public comment in the Federal Register
on October 23, 2008 (73 FR 63153). The
MedWatchPlus Portal and Rational
Questionnaire are components of a new
electronic system for collecting,
submitting, and processing adverse
event reports and other safety
information for all FDA-regulated
products.
In this 30-day notice, FDA is
requesting public comment on data
elements associated with revisions to
forms FDA 1932 and 1932a (both paper
and electronic) under revised OMB
control number 0910–0645, described
below. We will publish separately in the
Federal Register a 30-day notice to
complete the renewal of OMB control
number 0910–0284, the collection of
information using existing paper forms
FDA 2301, 1932, and 1932a, to provide
time for development of the revised
FDA Forms 1932 and 1932a and their
incorporation into the MedWatch OMB

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