41076 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert A. Sargis, 

Report Clearance Officer. 

[FR Doc. 2018–17768 Filed 8–16–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: LIHEAP Carryover 

and Reallotment Report FRN1 

Clearance. 

Title: Low Income Home Energy 

Assistance Program (LIHEAP) Carryover 

and Reallotment Report. 

OMB No.: 0970–0106. 

Description: The LIHEAP statute and 

regulations require LIHEAP grantees to 

report certain information to HHS 

concerning funds forwarded and funds 

subject to reallotment. The 1994 

reauthorization of the LIHEAP statute, 

the Human Service Amendments of 

1994 (Pub. L. 103–252), requires that the 

carryover and reallotment report for one 

fiscal year be submitted to HHS by the 

grantee before the Allotment for the next 

fiscal year may be awarded. 

We are requesting no changes in the 

collection of data with the Carryover 

and Reallotment Report for FY 2018, a 

form for the collection of data, and the 

Simplified Instructions for Timely 

Obligations of FY 2019 LIHEAP Funds 

and Reporting Funds for Carryover and 

Reallotment. The form clarifies the 

information being requested and 

ensures the submission of all the 

required information. The form 

facilitates our response to numerous 

queries each year concerning the 

amounts of obligated funds. Use of the 

form is voluntary. Grantees have the 

option to use another format. 

Respondents: State, Local or Tribal 

Government. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Carryover & Reallotment ................................................................................. 177 1 3 531 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 531 

In compliance with the requirements 

of the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. Chap 35), the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW, 

Washington DC 20201. Attn: ACF 

Reports Clearance Officer. Email 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert A. Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–17777 Filed 8–16–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0001] 

Science and Regulation of Live 

Microbiome-Based Products Used To 

Prevent, Treat, or Cure Diseases in 

Humans; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for 

Biologics Evaluation and Research and 

the National Institutes of Health, 

National Institute of Allergy and 

Infectious Diseases (NIAID) are 

announcing a public workshop entitled 

‘‘Science and Regulation of Live 

Microbiome-Based Products Used to 

Prevent, Treat, or Cure Diseases in 

Humans.’’ The purpose of the public 

workshop is to exchange information 

with the scientific community about the 

clinical, manufacturing, and regulatory 

considerations associated with live 

microbiome-based products, when 

administered to prevent, treat, or cure a 

disease or condition in humans. The 

public workshop will bring together 

government Agencies, academia, 

industry, and other stakeholders 

involved in research, development, and 

regulation of live microbiome-based 

products for such uses. 

DATES: The public workshop will be 

held on September 17, 2018, from 9 a.m. 

to 5 p.m. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: The public workshop will 

be held at the NIAID Conference Center, 

5601 Fishers Lane, Rm. 1D13, Rockville, 

MD 20852. Entrance for public 

workshop participants is through the 

lobby, where routine security check 

procedures will be performed. For 

parking and security information, please 

refer to https://www.niaid.nih.gov/ 

about/visitor-information. 

FOR FURTHER INFORMATION CONTACT: Loni 

Warren Henderson or Sherri Revell, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 1118, Silver Spring, 

MD 20993, 240–402–8010, email: 

CBERPublicEvents@fda.hhs.gov (subject 


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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41077 

line: Live Microbiome-Based Products 

Workshop). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Live microbiome-based products used 

to prevent, treat, or cure a disease or 

condition in humans are biological 

products. There is increasing interest in 

the use of such products for the 

treatment and/or prevention of 

conditions such as necrotizing 

enterocolitis and diarrhea. Historically, 

these products have presented with 

unique scientific and regulatory 

challenges. 

II. Topics for Discussion at the Public 

Workshop 

The topics for discussion at the public 

workshop include the clinical, 

manufacturing, and regulatory 

considerations for live microbiomebased products to prevent, treat, or cure 

a disease or condition in humans, and 

the objective is to provide a forum for 

the exchange of information and 

perspectives on these topics. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit the following 

website: https://www.eventbrite.com/e/ 

science-and-regulation-of-livemicrobiome-based-products-used-toprevent-treat-or-cure-diseases-in-tickets44649072578. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by August 28, 2018, midnight 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. There will be no onsite 

registration. 

If you need special accommodations 

due to a disability, please contact Loni 

Warren Henderson or Sherri Revell no 

later than September 10, 2018 (See FOR

FURTHER INFORMATION CONTACT). 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17732 Filed 8–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1592] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Controlled Correspondence 

Related to Generic Drug Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 September 

17, 2018. 

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 0910–0797. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10a.m.–12 midnight, 

11601 Landsdown St., North Bethesda, 

MD 20852, 301–796–5733, 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: Controlled 

Correspondence Related to Generic 

Drug Development 

OMB Control Number 0910–0797— 

Extension 

This information collection supports 

the above captioned Agency guidance. 

FDA has agreed to specific program 

enhancements and performance goals 

specified in the Generic Drug User Fee 

Reauthorization (GDUFA II) 

Commitment Letter. One of the 

performance goals applies to controlled 

correspondence related to generic drug 

development. The GDUFA II 

Commitment Letter includes details on 

FDA’s commitment to respond to 

questions submitted as controlled 

correspondence within certain 

timeframes. To support these program 

goals, we have developed the guidance 

entitled ‘‘Controlled Correspondence 

Related to Generic Drug Development.’’ 

The guidance document is intended to 

facilitate FDA’s prompt consideration of 

controlled correspondence and to assist 

in meeting the prescribed timeframes by 

providing procedural recommendations 

to include the following information in 

the inquiry: (1) Name, title, address, 

phone number, and entity of the person 

submitting the inquiry; (2) a letter of 

authorization, if applicable; (3) the FDAassigned control number and 

submission date of any previous, related 

controlled correspondence that was 

accepted for substantial review and 

response, if any, as well as a copy of 

that previous controlled correspondence 

and FDA’s response, if any; (4) the 

relevant reference listed drug(s), as 

applicable, including the application 

number, proprietary (brand) name, 

manufacturer, active ingredient, dosage 

form, and strength(s); (5) a statement 

that the controlled correspondence is 

related to a potential abbreviated new 

drug application (ANDA) submission to 

the Office of Generic Drugs and the 

ANDA number, if applicable; (6) a 

concise statement of the inquiry; (7) a 

recommendation of the appropriate FDA 

review discipline; and (8) relevant prior 

research and supporting materials. 

The GDUFA II Commitment Letter 

also includes details on FDA’s 

commitment to respond to requests to 

clarify ambiguities in FDA’s controlled 

correspondence response within certain 

timeframes. To facilitate FDA’s prompt 

consideration of the request and to 

assist in meeting the prescribed 

timeframes, the guidance document 

recommends including the following 

information in the inquiry: (1) Name, 

title, address, phone number, and entity 

of the person submitting the inquiry; (2) 

a letter of authorization, if applicable; 

(3) the FDA-assigned control number, 

submission date of the controlled 

correspondence on which the requestor 

is seeking clarification, a copy of that 

previous controlled correspondence, 

and FDA’s response to the controlled 

correspondence; and (4) the clarifying 

questions and the corresponding 

section(s) of FDA’s controlled 

correspondence response on which the 

requestor is seeking clarification. 

In the Federal Register of May 22, 

2018, (83 FR 23692), we published a 60- 

day notice requesting public comment 

on the proposed collection of 


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