Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 77009 

Place: NCHS Headquarters, 3311 

Toledo Road, Hyattsville, Maryland 

20782. 

Status: This meeting is open to the 

public; however, visitors must be 

processed in accordance with 

established federal policies and 

procedures. For foreign nationals or 

non-U.S. citizens, pre-approval is 

required (please contact Gwen Mustaf, 

301–458–4500, glm4@cdc.gov, or 

Virginia Cain, vcain@cdc.gov at least 10 

days in advance for requirements). All 

visitors are required to present a valid 

form of picture identification issued by 

a state, federal or international 

government. As required by the Federal 

Property Management Regulations, title 

41, Code of Federal Regulation, subpart 

101–20.301, all persons entering in or 

on Federal controlled property and their 

packages, briefcases, and other 

containers in their immediate 

possession are subject to being x-rayed 

and inspected. Federal law prohibits the 

knowing possession or the causing to be 

present of firearms, explosives and other 

dangerous weapons and illegal 

substances. The meeting room 

accommodates approximately 100 

people. 

Purpose: This committee is charged 

with providing advice and making 

recommendations to the Secretary, 

Department of Health and Human 

Services; the Director, CDC; and the 

Director, NCHS, regarding the scientific 

and technical program goals and 

objectives, strategies, and priorities of 

NCHS. 

Matters for Discussion: The agenda 

will include: 

1. Welcome remarks by the Director, 

NCHS 

2. An update on health insurance 

coverage data 

3. A presentation on Statistical Policy 

Directive No. 1: ‘‘Fundamental 

Responsibilities of Federal 

Statistical Agencies and Recognized 

Statistical Units’’. 

Requests to make oral presentations 

should be submitted in writing to the 

contact person listed below. All requests 

must contain the name, address, 

telephone number, and organizational 

affiliation of the presenter. 

Written comments should not exceed 

five single-spaced typed pages in length 

and must be received by January 8, 

2015. 

The agenda items are subject to 

change as priorities dictate. 

Contact Person for More Information: 

Virginia S. Cain, Ph.D., Director of 

Extramural Research, NCHS/CDC, 3311 

Toledo Road, Room 7208, Hyattsville, 

Maryland 20782, telephone (301) 458– 

4500, fax (301) 458–4024. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2014–29963 Filed 12–22–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Grant Reviewer Recruitment 

Form. 

OMB No.: NEW. 

Description: The Administration for 

Children and Families’s Children’s 

Bureau (CB) is responsible for 

administering the review of eligible 

grant applications submitted in 

response to funding opportunity 

announcements issued by CB. CB 

ensures that the objective review 

process is independent, efficient, 

effective, economical, and complies 

with the applicable statutes, regulations, 

and policies. Applications are reviewed 

by subject experts knowledgeable in 

child welfare and related fields. Review 

findings are advisory to CB; CB is 

responsible for making award decisions. 

This announcement is a request for 

approval of the proposed information 

collection system, the Reviewer 

Recruitment Module (RRM). CB will use 

a web-based data collection form and 

database to gather critical reviewer 

information in drop down menu format 

for data such as: degree, occupation, 

affiliations with organizations and 

institutions that serve special 

populations, and demographic 

information that may be voluntarily 

provided by a potential reviewer. 

These data elements will help CB find 

and select expert grant reviewers for 

objective review committees. The webbased system will permit reviewers to 

access and update their information at 

will and as needed. The RRM will be 

accessible by the general public via 

https://rrm.grantsolutions.gov/

AgencyPortal/cb.aspx. 

Respondents: Generally, our 

reviewers are current or retired 

professionals with backgrounds in child 

welfare and related fields and in some 

instances current or former foster care 

parents or clients. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

Reviewer recruitment module .......................................................................... 500 1 .25 125 

Estimated Total Annual Burden 

Hours: 125. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

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77010 Federal Register / Vol. 79, No. 246 / Tuesday, December 23, 2014 / Notices 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–29978 Filed 12–22–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1076] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 22, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0563. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Formal 

Dispute Resolution: Scientific and 

Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice (OMB Control 

Number 0910–0563)—Extension 

The guidance is intended to provide 

information to manufacturers of 

veterinary and human drugs, including 

human biological drug products, on 

how to resolve disputes of scientific and 

technical issues relating to current good 

manufacturing practice (CGMP). 

Disputes related to scientific and 

technical issues may arise during FDA 

inspections of pharmaceutical 

manufacturers to determine compliance 

with CGMP requirements, or during 

FDA’s assessment of corrective actions 

undertaken as a result of such 

inspections. The guidance provides 

procedures that encourage open and 

prompt discussion of disputes and lead 

to their resolution. The guidance 

describes procedures for raising such 

disputes to the Office of Regulatory 

Affairs (ORA) and center levels and for 

requesting review by the dispute 

resolution (DR) Panel. 

When a scientific or technical issue 

arises during an FDA inspection, the 

manufacturer should initially attempt to 

reach agreement on the issue informally 

with the investigator. Certain scientific 

or technical issues may be too complex 

or time consuming to resolve during the 

inspection. If resolution of a scientific or 

technical issue is not accomplished 

through informal mechanisms prior to 

the issuance of Form FDA 483, the 

manufacturer can formally request DR 

and can use the formal two-tiered DR 

process described in the guidance. 

Tier one of the formal DR process 

involves scientific or technical issues 

raised by a manufacturer to the ORA 

and center levels. If a manufacturer 

disagrees with the tier-one decision, 

tier-two of the formal DR process would 

then be available for appealing that 

decision to the DR panel. The written 

request for formal DR to the appropriate 

ORA unit should be made within 30 

days of the completion of an inspection, 

and should include all supporting 

documentation and arguments for 

review, as described in this document. 

The written request for formal DR to the 

DR Panel should be made within 60 

days of receipt of the tier-one decision 

and should include all supporting 

documentation and arguments, as 

described in the following paragraphs. 

All requests for formal DR should be 

in writing and include adequate 

information to explain the nature of the 

dispute and to allow FDA to act quickly 

and efficiently. Each request should be 

sent to the appropriate address listed in 

the guidance and include the following: 

• Cover sheet that clearly identifies 

the submission as either a request for 

tier-one DR or a request for tier-two DR; 

• name and address of manufacturer 

inspected (as listed on FDA Form 483); 

• date of inspection (as listed on 

Form FDA 483); 

• date Form FDA 483 issued (from 

Form FDA 483); 

• facility Establishment Identifier 

Number, if available (from Form FDA 

483); 

• FDA employee names and titles that 

conducted inspection (from Form FDA 

483); 

• office responsible for the inspection 

(e.g., district office, as listed on Form 

FDA 483); 

• application number if the 

inspection was a preapproval 

inspection; 

• comprehensive statement of each 

issue to be resolved: 

Æ Identify the observation in dispute; 

Æ clearly present the manufacturer’s 

scientific position or rationale 

concerning the issue under dispute with 

any supporting data; 

Æ state the steps that have been taken 

to resolve the dispute, including any 

informal DR that may have occurred 

before the issuance of Form FDA 483; 

Æ identify possible solutions; and 

Æ state expected outcome. 

• Name, title, telephone and FAX 

number, and email address (as 

available) of manufacturer contact. 

The guidance was initiated in 

response to industry’s request for a 

formal DR process to resolve differences 

related to scientific and technical issues 

that arise between investigators and 

pharmaceutical manufacturers during 

FDA inspections of foreign and 

domestic manufacturers. In addition to 

encouraging manufacturers to use 

currently available DR processes, the 

guidance describes the formal twotiered DR process explained previously. 

The guidance also covers the following 

topics: 

• The suitability of certain issues for 

the formal DR process, including 

examples of some issues with a 

discussion of their appropriateness for 

the DR process. 

• Instructions on how to submit 

requests for formal DR and a list of the 

supporting information that should 

accompany these requests. 

• Public availability of decisions 

reached during the DR process to 

promote consistent application and 

interpretation of drug quality-related 

regulations. 

Description of Respondents: 

Pharmaceutical manufacturers of 

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