18240 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on the draft guidance and that comment 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notice finalizes the draft guidance dated 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. 

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. 

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] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: 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 

paperwork@hrsa.gov 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 paperwork@hrsa.gov 

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. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 18241 

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 

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: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Designation Planning and Preparation ................................ 54 1 54 4.25 229.50 

SDMS Application ................................................................ 54 23 1,242 1.75 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] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

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. 

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, 

neuhuber@ninds.nih.gov. 

(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] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

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. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES