Attachment I - 60-day FRN

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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices

1, 2011, to comment on the draft
guidance. FDA received one comment
on the draft guidance and that comment
was considered as the guidance was
finalized. Two of the questions and
answers were revised, in addition to a
few editorial changes made to improve
clarity. The guidance announced in this
notice finalizes the draft guidance dated
December 2, 2010.
On July 1, 2008, the USP
implemented a requirement for the
control of residual solvents in drug
products marketed in the United States.
Once implemented, the requirement,
USP General Chapter <467> Residual
Solvents, became a statutory
requirement under section 501(b) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 351(b)). This
document answers questions regarding
CVM’s implementation of USP <467>
Residual Solvents.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Residual Solvents
in Animal Drug Products; Questions and
Answers.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.

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III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 514 have been approved
under OMB control number 0910–0032;
the collections of information in section
512(n)(1) of the FD&C Act (21 U.S.C.
360k) have been approved under OMB
control number 0910–0669.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to http://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at http://
www.regulations.gov.

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V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
http://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
http://www.regulations.gov.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07632 Filed 4–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than June 8, 2015.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 10C–03, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Shortage Designation Management
System OMB No. 0906–xxxx–New.
SUMMARY:

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Abstract: HRSA’s Bureau of Health
Workforce (BHW) is committed to
improving the health of the nation’s
underserved communities and
vulnerable populations by developing,
implementing, evaluating, and refining
programs that strengthen the nation’s
health workforce. The Department of
Health and Human Services relies on
two federal shortage designations to
identify and dedicate resources to areas
and populations in greatest need of
providers: Health Professional Shortage
Area (HPSA) designations and
Medically Underserved Area/Medically
Underserved Population (MUA/P)
designations. HPSA designations are
geographic areas, population groups,
and facilities that are experiencing a
shortage of health professionals. MUA/
P designations are areas, or populations
within areas, that are experiencing a
shortage of health care services. MUAs
are designated for the entire population
of a particular geographic area. MUP
designations are limited to particular
groups of underserved people within an
area. These designations are currently
used in a number of departmental
programs that provide both federal and
state government grant/program benefits
for communities, health care facilities,
and providers. BHW has the
responsibility for designating and dedesignating HPSAs and MUA/Ps on
behalf of the Secretary.
HPSA designations are required to be
reviewed and updated regularly to
reflect current data. Individual states—
through their Primary Care Office
(PCO)—have primary responsibility for
initiating an application for a new or
updated HPSA designation, or
withdrawing HPSAs that no longer meet
the designation criteria. HRSA reviews
the application and makes the final
determination on the HPSA designation.
Requests come from the PCOs who have
access to the online application and
review system, Shortage Designation
Management System (SDMS). Requests
that come from other sources are
referred to the PCOs for their review and
concurrence. In addition, interested
parties, including the Governor, the
State Primary Care Association, and
state professional associations are
notified of each request submitted for
their comments and recommendations.
In order to obtain a federal shortage
designation for an area, population, or
facility, PCOs must submit a shortage
designation application through SDMS
for review and approval by BHW. Both
the HPSA and MUA/P application
request local, state, and national data on
the population that is experiencing a
shortage of health professionals and the
number of health professionals relative

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18241

Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
to the population covered by the
proposed designation. The information
collected on the applications is used to
determine which areas, populations,
and facilities have shortages.
The lists of designated HPSAs are
annually published in the Federal
Register. In addition, lists of HPSAs are
updated on the HRSA Web site,
http://www.hrsa.gov/shortage/, so that
interested parties can access the
information.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to obtain
information to designate HPSAs and
MUA/Ps. The information obtained
from the SDMS Application is used to
determine which areas, populations,
and facilities have critical shortages of
health professionals. The SDMS HPSA

application and SDMS MUA/P
Application are used for these
designation determinations. Applicants
must submit a SDMS application to
BHW to obtain a federal shortage
designation. The application asks for
local, state, and national data required
to determine the applicant’s eligibility
to obtain a federal shortage designation.
In addition, applicants must enter in
detailed information explaining how the
area, population, or facility faces a
critical shortage of health professionals.
Likely Respondents: State Primary
Care Offices interested in obtaining a
primary care, dental, or mental HPSA
designation or a MUA/P in their state.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
Number of
respondents

Form name

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Designation Planning and Preparation ................................
SDMS Application ................................................................

54
54

1
23

54
1,242

4.25
1.75

229.50
2,173.50

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

54

—

1,296

—

2,403.00

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–07673 Filed 4–2–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
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Number of
responses per
respondent

requested. 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
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. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose

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confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; UDALL Center Review.
Date: April 22–23, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel & Spa, 1600 King
Street, Alexandria, VA 22314.
Contact Person: Birgit Neuhuber, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
INDS/NIH/DHHS/Neuroscience Center, 6001
Executive Boulevard, Suite 3208, MSC 9529,
Bethesda, MD 20892–9529, 301–496–3562,
[email protected].

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: March 30 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07627 Filed 4–2–15; 8:45 am]
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National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting

Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: HIV/AIDS Innovative Research
Applications.
Date: April 7, 2015.
Time: 11:00 a.m. to 3:00 p.m..
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for

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