Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 18239 

comments should be received within 30 

days of this notice. 

Proposed Project 

World Trade Center Health Program 

Petition for the Addition of a New WTCRelated Health Condition for Coverage 

under the World Trade Center (WTC) 

Health Program (OMB No. 0920–0929, 

expiration 04/30/2015)—Revision— 

Centers for Disease Control and 

Prevention (CDC), National Institutes for 

Occupational Safety and Health 

(NIOSH). 

Background and Brief Description 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII establishing the WTC 

Health Program within the Department 

of Health and Human Services (HHS). 

The WTC Health Program provides 

medical monitoring and treatment 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery, and 

cleanup workers who responded to the 

September 11, 2001, terrorist attacks in 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania (responders), 

and to eligible persons who were 

present in the dust or dust cloud on 

September 11, 2001 or who worked, 

resided, or attended school, childcare, 

or adult daycare in the New York City 

disaster area (survivors). 

PHS Act § 3312(a)(3) identifies a list 

of health conditions for which 

individuals who are enrolled in the 

WTC Health Program may be monitored 

or treated. PHS Act § 3312(a)(6)(B) 

specifies that interested parties may 

petition the Administrator of the WTC 

Health Program to request that a new 

health condition be added to the List of 

WTC-Related Health Conditions in 42 

CFR 88.1. To aid the petitioner, the 

WTC Health Program provides a 

petition form to be completed and then 

sent to the Administrator for review. 

However, the petitioner is not required 

to use the form, and may submit a 

petition in a different format, provided 

it contains all of the data elements 

requested on the form. 

Data elements include the interested 

party’s name, contact information, 

signature, and a statement about the 

medical basis for the relationship/

association between the 9/11 exposure 

and the proposed health condition, 

which the Administrator of the WTC 

Health Program will use to determine 

whether to propose a rule to add the 

condition, to not to add the condition, 

or to seek a recommendation from the 

Scientific/Technical Advisory 

Committee (STAC). 

The petition form is amended slightly 

to reflect a WTC Health Program policy 

change. The current form asks 

respondents to offer reference to ‘‘a 

peer-reviewed, published, 

epidemiologic study.’’ The revised form 

will ask respondents to reference ‘‘peerreviewed, published, epidemiologic 

and/or direct observational studies.’’ 

The submission of a petition is purely 

voluntary, and is not required or 

otherwise compelled by NIOSH or the 

WTC Health Program. 

NIOSH expects to receive no more 

than 20 submissions annually. 

Petitioners include prospective and 

enrolled WTC responders, screeningeligible survivors, certified-eligible 

survivors, or members of groups who 

advocate on behalf of responders or 

survivors, such as physicians. It is 

estimated that an individual spends an 

average of 40 hours gathering 

information to substantiate a request to 

add a health condition and assembling 

the petition. The total estimated 

annualized burden hours are 800. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Responder/Survivor/Advocate (physician) ...... Petition for the addition of health conditions 20 1 40 

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. 2015–07670 Filed 4–2–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0566] 

Residual Solvents in Animal Drug 

Products; Questions and Answers; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

#211 entitled ‘‘Residual Solvents in 

Animal Drug Products; Questions and 

Answers.’’ The questions and answers 

guidance addresses the United States 

Pharmacopeia (USP) General Chapter 

<467> Residual Solvents that applies to 

both human and veterinary drugs and to 

compendial and non-compendial drug 

products. This document answers 

questions regarding the Center for 

Veterinary Medicine’s (CVM) 

implementation of USP <467> Residual 

Solvents. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Heather Longstaff, Center for Veterinary 

Medicine (HFV–145), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0651, 

email: heather.longstaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 3, 

2010 (75 FR 75482), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Residual Solvents in Animal 

Drug Products; Questions and Answers’’ 

giving interested persons until February 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 


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