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 


amozie on DSK3GDR082PROD with NOTICES1
41078 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 

information. No comments were 

received. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Submission of controlled correspondence Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

Generic drug manufacturers, related industry, and representatives ...................................................................... 390 3.8 1,496 5 7,480 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

This is the first extension of the 

information collection. We base our 

estimate on a review of Agency data of 

Fiscal Year submissions for 2014, 2015, 

and 2016, which reflects an increase in 

submissions that we attribute to an 

increase in generic drug development. 

Accordingly, we estimate 390 generic 

drug manufacturers and related industry 

(e.g., contract research organizations 

conducting bioanalytical or 

bioequivalence clinical trials) or their 

representatives will each submit an 

average of 3.8 inquiries annually for a 

total of 1,496 inquiries [1,496 ÷ 390 = 

3.8]. Information submitted with each 

inquiry varies widely in content, 

depending on the complexity of the 

request. Inquiries that are defined as 

controlled correspondence may range 

from a simple inquiry on generic drug 

labeling to a more complex inquiry for 

a formulation assessment for a specific 

proposed generic drug product. As a 

result, these inquiries can vary between 

1 and 10 burden hours. 

Because the content of inquiries 

considered controlled correspondence is 

widely varied, we are providing an 

average burden hour for each inquiry. 

We estimate that it will take an average 

of 5 hours per inquiry for industry to 

gather necessary information, prepare 

the request, and submit the request to 

FDA. As a result, we estimate that it will 

take an average of 7,480 hours annually 

for industry to prepare and submit 

inquiries considered controlled 

correspondence. 

Dated: August 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17787 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–2310] 

Process To Request a Review of Food 

and Drug Administration’s Decision 

Not To Issue Certain Export 

Certificates for Devices; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Process to Request a 

Review of FDA’s Decision Not to Issue 

Certain Export Certificates for Devices; 

Draft Guidance for Industry and Food 

and Drug Administration Staff.’’ FDA is 

issuing this draft guidance to comply 

with changes to the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) as 

amended by the FDA Reauthorization 

Act of 2017 (FDARA), to specify the 

process afforded to persons denied a 

Certificate to Foreign Government (CFG) 

for a device. This draft guidance 

describes the information that the 

Center for Devices and Radiological 

Health (CDRH) and the Center for 

Biologics Evaluation and Research 

(CBER) will provide to a person whose 

request for a CFG for a device is denied, 

and the process for seeking review of 

such a denial. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 16, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–2310 for ‘‘Process to Request a 

Review of FDA’s Decision Not to Issue 

Certain Export Certificates for Devices; 

Draft Guidance for Industry and Food 

and Drug Administration Staff.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 


amozie on DSK3GDR082PROD with NOTICES1