Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26699 

to respond to, a collection of information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB 

control No. 

Date 

approval 

expires 

Biological Products—General Records and Postmarket Adverse Experience Reporting ...................................... 0910–0308 4/30/2021 

Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application 

Review .................................................................................................................................................................. 0910–0389 4/30/2021 

Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 ..................................... 0910–0498 4/30/2021 

Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy 

and Lactation Labeling ......................................................................................................................................... 0910–0624 4/30/2021 

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics .................................... 0910–0629 4/30/2021 

Guidance of Industry: Expedited Programs for Serious Conditions—Drugs and Biologics ................................... 0910–0765 4/30/2021 

Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign .......................................................... 0910–0851 4/30/2021 

Dated: June 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12338 Filed 6–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0232] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Interstate Shellfish 

Dealer’s Certificate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of the Interstate 

Shellfish Dealer’s Certificate. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 7, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 7, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of August 7, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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– 

2009–N–0232 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Interstate 

Shellfish Dealer’s Certificate.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 


amozie on DSK3GDR082PROD with NOTICES1
26700 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Interstate Shellfish Dealer’s Certificate 

OMB Control Number 0910–0021— 

Extension 

Under Section 243 of the Public 

Health Service Act (42 U.S.C. 243), FDA 

is required to cooperate with and aid 

State and local authorities in the 

enforcement of their health regulations 

and are authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the molluscan shellfish 

industry in the National Shellfish 

Sanitation Program (NSSP). 

NSSP is a voluntary, cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish processors. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

processors and issues certificates for 

those that meet the State or foreign 

shellfish control authority’s criteria. 

Each participating State and nation 

provides a certificate of its certified 

shellfish processors to FDA on Form 

FDA 3038, ‘‘Interstate Shellfish Dealer’s 

Certificate.’’ FDA uses this information 

to publish the ‘‘Interstate Certified 

Shellfish Shippers List,’’ a monthly 

comprehensive listing of all molluscan 

shellfish processors certified under the 

cooperative program. If FDA did not 

collect the information necessary to 

compile this list, participating States 

would not be able to identify and keep 

out shellfish processed by uncertified 

processors in other States and foreign 

nations. Consequently, NSSP would not 

be able to control the distribution of 

uncertified and possibly unsafe shellfish 

in interstate commerce, and its 

effectiveness would be nullified. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity FDA Form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average burden 

per response Total hours 

Submission of Interstate Shellfish Dealer’s Certificate.3038 40 57 2,280 0.10 (6 minutes) ............. 228 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. We 

estimate that 40 respondents will 

submit 2,280 Interstate Shellfish 

Dealer’s Certificates annually, for a total 

burden of 228 hours (2,280 submissions 

× 0.10 hours = 228 hours). This estimate 

is based on our experience with this 

information collection and the number 

of certificates received in the past 3 

years, which has remained constant. 

Dated: June 4, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12340 Filed 6–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Advancing Translational Sciences Special 


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