18238 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 

of marketed and investigational human 

drug products for use in the treatment 

of cancer. 

G. Science Advisory Board to the 

National Center for Toxicological 

Research: Reviews and advises the 

Agency on the establishment, 

implementation and evaluation of the 

research programs and regulatory 

responsibilities as it relates to NCTR. 

The Board will also provide an extraAgency review in ensuring that the 

research programs at NCTR are 

scientifically sound and pertinent. 

H. Vaccines and Related Biological 

Products Advisory Committee: Reviews 

and evaluates data concerning the 

safety, effectiveness, and appropriate 

use of vaccines and related biological 

products which are intended for use in 

the prevention, treatment, or diagnosis 

of human diseases, as well as considers 

the quality and relevance of FDA’s 

research program which provides 

scientific support for the regulation of 

these products. 

II. Criteria for Members 

Persons nominated for membership as 

consumer representatives on 

committees or panels should meet the 

following criteria: (1) Demonstrate ties 

to consumer and community-based 

organizations, (2) be able to analyze 

technical data, (3) understand research 

design, (4) discuss benefits and risks, 

and (5) evaluate the safety and efficacy 

of products under review. The 

consumer representative should be able 

to represent the consumer perspective 

on issues and actions before the 

advisory committee; serve as a liaison 

between the committee and interested 

consumers, associations, coalitions, and 

consumer organizations; and facilitate 

dialogue with the advisory committees 

on scientific issues that affect 

consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

or nonvoting member to represent 

consumer interests should send a letter 

stating that interest to FDA (see 

ADDRESSES) within 30 days of 

publication of this document. 

Within the subsequent 30 days, FDA 

will compile a list of consumer 

organizations that will participate in the 

selection process and will forward to 

each such organization a ballot listing at 

least two qualified nominees selected by 

the Agency based on the nominations 

received, together with each nominee’s 

current curriculum vitae or resume. 

Ballots are to be filled out and returned 

to FDA within 30 days. The nominee 

receiving the highest number of votes 

ordinarily will be selected to serve as 

the member representing consumer 

interests for that particular advisory 

committee or panel. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Agency’s advisory committees or 

panels. Self-nominations are also 

accepted. Nominations should include a 

cover letter and a current curriculum 

vitae or resume for each nominee, 

including a current business and/or 

home address, telephone number, and 

email address if available, and a list of 

consumer or community-based 

organizations for which the candidate 

can demonstrate active participation. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

Nominations should also specify the 

advisory committee(s) or panel(s) for 

which the nominee is recommended. In 

addition, nominations should include 

confirmation that the nominee is aware 

of the nomination, unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 

permit evaluation of possible sources of 

conflicts of interest. Members will be 

invited to serve for terms up to 4 years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. Upon 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

Dated: March 30, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07605 Filed 4–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–0929] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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