60 Day FRN

Attachment 2 - 60-Day Federal Register Notice
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–14–0765]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying

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information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Fellowship Management System
(OMB No. 0920–0765, expires 02/28/
2015)—Revision—Division of Scientific
Education and Professional
Development (DSEPD), Center for
Surveillance, Epidemiology, and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
DSEPD requests an additional three
years to continue CDC’s use of the
Fellowship Management System (FMS)
for its electronic application, host site,
and directory processes that allow
individuals to apply to fellowships
online, allow public health agencies to
submit fellowship assignment proposals
online, and track applicant and alumni
information. An extension will allow
applicants, public health agencies, and
alumni continued use of FMS for
submission of electronic data.
The mission of DSEPD is to improve
health outcomes through a competent,
sustainable, and empowered public
health workforce. Professionals in
public health, epidemiology, medicine,
economics, information science,
veterinary medicine, nursing, public
policy, and other related professionals
seek opportunities, through CDC
fellowships, to broaden their
knowledge, skills, and experience to
improve the science and practice of
public health. CDC fellows are assigned
to state, tribal, local, and territorial
public health agencies; federal
government agencies, including CDC
and Department of Health and Human
Services’ (HHS) operational divisions,
such as Centers for Medicare &
Medicaid Services; and to
nongovernmental organizations,
including academic institutions, tribal
organizations, and private public health
organizations.

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FMS provides an efficient and
effective electronic mechanism for
collecting and processing fellowship
application data and fellowship host
site assignment proposals; selecting
qualified candidates; matching selected
fellowship host site assignments with
applicants; maintaining a current
alumni database; generating reports; and
documenting the impact of fellowships
on alumni careers. FMS optimizes
CDC’s ability to provide continuous
fellowship service delivery that builds
and sustains public health capacity and
helps to save lives and protect people
from health threats. This proposed
extension allows CDC to continue to use
standardized electronic tools for
streamlined collection of fellowship
applications and fellowship assignment
proposals, in the process collecting
alumni information that will be used to
document the impact of public health
fellowships on career paths and on the
science and practice of public health.
This information collection request
was established to support making
contextual non-substantive changes to
application and host site questions and
directions to accurately reflect evolving
fellowship eligibility requirements,
provide clarification of existing
questions, and accommodate changing
needs of host organizations. Nonsubstantive changes of this nature will
be requested with this extension to
include, e.g., supporting the submission
of electronic transcripts and letters of
recommendation in lieu of postal
delivery; refining selected questions to
align with current fellowship eligibility
requirements; and clarifying
instructions in response to user
feedback. DSEPD/CSELS will be
eliminating the data collection for two
fellowships that are being discontinued
(the Public Health Prevention Specialist
Program and the CDC Experience
Applied Epidemiology Fellowship). No
change in burden to individual
respondents will result from these nonsubstantive changes.
The annual burden table has been
updated to reflect the number of
respondents from nonfederal fellowship
applicants, public health agencies, and
fellowship alumni. There is no cost to
respondents other than their time.

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Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Public health agency or organization

Fellowship Management System
Host Site.
Fellowship Management System
Application.
Fellowship Management System Directory.

Fellowship applicants ........................
Fellowship alumni* ............................
Total ...........................................

Number of
responses
per
respondent

Number of
respondents

Type of respondent

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

Average
burden per
response
(in hours)

Total
burden
hours

394

1

85/60

558

1,961

1

40/60

1,307

1,382

1

15/60

346

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

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

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

2,211

* Some alumni are deceased or cannot be located. Response burden assumes response from an individual responding alumnus, on average,
every three years (which is a likely overestimate of frequency).
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–22752 Filed 9–24–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Veterinary Feed
Directive
Food and Drug Administration,

HHS.
ACTION:

Notice.

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
reporting and recordkeeping
requirements for distribution and use of
Veterinary Feed Directive (VFD) drugs
and animal feeds containing VFD drugs.
DATES: Submit electronic or written
comments on the collection of
information by November 24, 2014.
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

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SUMMARY:

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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)

SUPPLEMENTARY INFORMATION:

[Docket No. FDA–2010–N–0155]

AGENCY:

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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.

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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.
Veterinary Feed Directive—21 CFR 558;
OMB Control Number 0910–0363—
Extension
With the passage of the Animal Drug
Availability Act, Congress enacted
legislation establishing a new class of
restricted feed use drugs, VFD drugs,
which may be distributed without
involving state pharmacy laws.
Although controls on the distribution
and use of VFD drugs are similar to
those for prescription drugs regulated
under section 503(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
353(f)), the implementing VFD
regulation (21 CFR 558.6) was tailored
to the unique circumstances relating to
the distribution of medicated feeds. All
distributors of medicated feed
containing VFD drugs must notify FDA
of their intent to distribute, and records
must be maintained of the distribution
of all medicated feeds containing VFD
drugs. The VFD regulation ensures the
protection of public health while
enabling animal producers to obtain and
use needed drugs as efficiently and cost
effectively as possible.
On December 12, 2013, FDA
published a proposed rule in the
Federal Register (78 FR 75515) intended
to improve the efficiency of FDA’s VFD
program. The provisions included in the
proposed rule were based on
stakeholder input received in response
to solicitations for public comment,
including an advance notice of
proposed rulemaking on March 29, 2010
(75 FR 15387), and draft text of
proposed amendments to the current
VFD regulations on April 13, 2012 (77
FR 22247).
While FDA intends to finalize the
VFD rulemaking in 2015, the current

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