62636 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 19, 

2014. 

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 requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http://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 

FDA is announcing the availability of 

a draft guidance for industry (GFI #227) 

entitled ‘‘Two-Phased Chemistry, 

Manufacturing, and Controls (CMC) 

Technical Sections.’’ It is intended to 

provide recommendations to industry 

regarding CMC data submitted to CVM 

to support approval of a new animal 

drug or abbreviated new animal drug. 

As specified in the Animal Drug User 

Fee Amendments of 2013 (ADUFA III) 

and Animal Generic Drug User Fee 

Amendments of 2013 (AGDUFA II) 

respective goals letters, the Agency 

agreed to develop guidance for a twophased CMC technical section 

submission and review process by the 

end of fiscal year 2014. 

The two-phased process allows for 

two separate CMC submissions, each 

with its own review clock, and each 

including complete appropriate CMC 

information that is available for review 

at the time of submission. The draft 

guidance specifies the technical details 

of how the process works, the review 

clocks, the information that is 

appropriate for each technical section 

submission, and the possible review 

outcomes. The guidance also includes 

CVM’s recommendations for meetings 

between the Division of Manufacturing 

Technologies and the sponsor during 

this process to ensure concurrence with 

the approach used for the CMC 

technical section. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft 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 this guidance have 

been approved under 0910–0032 and 

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 draft guidance at either 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: October 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24796 Filed 10–17–14; 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 December 19, 2014. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10–29, 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: 

The Secretary’s Discretionary Advisory 

Committee on Heritable Disorders in 

Newborns and Children’s Public Health 

System Assessment Surveys OMB No. 

0915-xxxx–New 

Abstract: The purpose of the public 

health system assessment surveys is to 

inform the Secretary’s Discretionary 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(Committee) on the ability to add 

newborn screening for particular 

conditions within a state, including the 

feasibility, readiness, and overall 

capacity to screen for a new condition. 

The Committee was established under 

the Public Health Service Act, 42 U.S.C. 

217a: Advisory Councils or Committees. 

This Committee fulfills the functions 

previously undertaken by the former 

Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children, established under Section 

1111 of the Public Health Service Act 

(PHS), 42 U.S.C. 300b–10, as amended 

in the Newborn Screening Saves Lives 

Act of 2008. The Committee is governed 

by the provisions of the Federal 

Advisory Committee Act (FACA), as 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices 62637 

amended (5 U.S.C. App.), which sets 

forth standards for the formation and 

use of advisory committees. The 

purpose of the Committee is to provide 

the Secretary with recommendations, 

advice, and technical information 

regarding the most appropriate 

application of technologies, policies, 

guidelines, and standards for: (a) 

Effectively reducing morbidity and 

mortality in newborns and children 

having, or at risk for, heritable 

disorders; and (b) enhancing the ability 

of state and local health agencies to 

provide for newborn and child 

screening, counseling, and health care 

services for newborns and children 

having, or at risk for, heritable 

disorders. Specifically, the Committee 

makes systematic evidence-based 

recommendations on newborn screening 

for conditions that have the potential to 

change the health outcomes for 

newborns. 

The Committee tasks an external 

workgroup to conduct systematic 

evidence based reviews. The reviews are 

of rare, genetic conditions and their 

corresponding newborn screening 

test(s), confirmatory test(s), and 

treatment(s). Reviews also include an 

analysis of the benefits and harms of 

newborn screening for a selected 

condition at a population level and an 

assessment of state public health 

newborn screening programs’ ability to 

implement the screening of a new 

condition. 

Need and Proposed Use of the 

Information: HRSA proposes that the 

data collection surveys be administered 

by the Committee’s external Condition 

Review Workgroup to all state newborn 

screening programs in the United States. 

The surveys were developed to capture 

the following: (1) The readiness of state 

public health newborn screening 

programs to expand newborn screening 

to include the target condition; (2) 

specific requirements of screening for 

the condition would hinder or facilitate 

its implementation in each state; and (3) 

estimated timeframes needed for each 

state to complete major milestones 

toward full newborn screening of the 

condition. 

The data gathered will inform the 

Committee on the following: (1) 

Feasibility of implementing populationbased screening for the target condition; 

(2) readiness of state newborn screening 

programs to adopt screening for the 

condition; (3) identify gaps in feasibility 

or readiness to screen for the condition; 

and (4) identify areas of technical 

assistance and resources needed to 

facilitate screening for conditions with 

low feasibility or readiness. 

Likely Respondents: The respondents 

to the survey will be state newborn 

screening programs. 

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 

INITIAL Survey ..................................................................... 59 1 59 10.0 590 

FOLLOW-UP Survey ........................................................... 1 30 1 30 2.0 60 

Total .............................................................................. 59 ........................ 89 ........................ 650 

1 Up to 30 states and/or territories will be asked to complete a follow-up survey. 

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. 

Dated: October 10, 2014. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–24870 Filed 10–17–14; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than November 19, 

2014. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 


tkelley on DSK3SPTVN1PROD with NOTICES