Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 133 

General advice is provided where 

modifications of the prescribing 

information for specific products are 

needed. 

FDA previously issued draft guidance 

on the prescribing information for COCs 

in March 2004 and invited public 

comment. That draft guidance was 

withdrawn in July 2015. However, the 

development of the current draft 

guidance took into consideration public 

comments submitted to the 2004 draft 

guidance that were science-based and 

consistent with current PLR and PLLR 

labeling regulations. This draft guidance 

has been broadened to incorporate the 

more general class of CHCs. 

FDA invites comments on the content 

of this draft guidance. In particular, 

FDA seeks comments on the proposed 

language under section 7.1 of labeling 

that identifies a drug interaction with all 

metabolic enzyme inducers. A variety of 

metabolic enzyme inducers have been 

reported to decrease the plasma 

concentration of the estrogen and/or 

progestin components of CHCs. FDA 

seeks comments and data regarding 

specific enzyme inducers or classes of 

inducers (e.g., cytochrome p450 3A 

strong inducers) that interact with 

CHCs; in particular, comments are 

requested on whether the CHC labeling 

should include specific inducers or 

classes of inducers, or if it should 

remain broad and essentially cover all 

possible cytochrome p (CYP) enzyme 

inducers of any pathway and potency. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 current thinking of FDA 

on labeling for CHCs. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information that 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 21 CFR 

201.56 and 201.57 (‘‘Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and Biological 

Products’’) are approved under OMB 

control number 0910–0572. The 

collections of information from the final 

rule entitled ‘‘Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products; Requirements 

for Pregnancy and Lactation Labeling’’ 

are approved under OMB control 

number 0910–0624. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov/. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28252 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2347] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and 

Cosmetic Export Certificate 

Application Process 

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 associated with 

export certificate applications for FDAregulated food and cosmetic products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 5, 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 March 5, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 5, 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– 

2014–N–2347 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food and 

Cosmetic Export Certificate Application 

Process.’’ 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 


daltland on DSKBBV9HB2PROD with NOTICES
134 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 

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 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Food and Cosmetic Export Certificate 

Application Process 

OMB Control Number 0910–0793— 

Revision 

Some countries may require 

manufacturers of FDA-regulated 

products to provide certificates for 

products they wish to export to that 

country. Accordingly, firms exporting 

products from the United States often 

ask FDA to provide such a ‘‘certificate.’’ 

In many cases, foreign governments are 

seeking official assurance that products 

exported to their countries can be 

marketed in the United States, or that 

they meet specific U.S. requirements. In 

some cases, review of an FDA export 

certificate may be required as part of the 

process to register or import a product 

into another country. An export 

certificate generally indicates that the 

particular product is marketed in the 

United States or otherwise eligible for 

export and that the particular 

manufacturer has no unresolved 

enforcement actions pending before, or 

taken by, FDA. FDA’s Center for Food 

Safety and Applied Nutrition (CFSAN) 

issues export certificates for food and 

cosmetic products. Interested persons 

may request a certificate electronically 

via the Certificate Application Process 

(CAP), a component of the FDA Industry 

Systems, or by contacting CFSAN for 

assistance. To facilitate the application 

process we have eliminated paper-based 

forms. For food products, we have 

expanded the electronic options for 

providing facility and product 

information. Respondents will now be 

able to identify facilities based on a food 

facility registration number, FDA 

Establishment Identification (FEI) 

number, or Data Universal Numbering 

System (DUNS) number. The system 

uses these identifiers to locate and autopopulate name and address information, 

eliminating the need for users to 

manually enter this information and 

reducing the time to complete the 

application. Respondents can also 

upload product information via a 

spreadsheet, which reduces the time 

needed to enter product information, 

particularly for applications that 

include multiple products. All 

information is entered using electronic 

Forms FDA 3613d, 3613e, 3613g, and 

3613l and used to evaluate certificate 

requests. 

While burden associated with 

information collection activities for 

export certificates issued for other FDAregulated products is approved under 

OMB control no. 0910–0498, this 

collection specifically supports export 

certificates issued by CFSAN. Also, 

because we have eliminated paperbased forms, respondents who require 

assistance with completing export 

certificate applications online may 

contact CFSAN directly by email 

(CFSANExportCertification@

fda.hhs.gov) or telephone (240–402– 

2307). Instructions for Form FDA 3613d 

are available online at https://

www.fda.gov/cosmetics/ 

internationalactivities/exporters/ 

ucm353912.htm and instructions for 

Form FDA 3613e are available online at 

https://www.fda.gov/Food/ 

GuidanceRegulation/ImportsExports/ 

Exporting/ucm260280.htm. Draft 

screenshots of Form FDA 3613g and 

3613l are available for comment online 

at https://www.fda.gov/Food/ 

GuidanceRegulation/ImportsExports/ 

Exporting/default.htm. 

Description of Respondents: The 

respondents to this collection of 

information are firms interested in 

exporting U.S.-manufactured food and 

cosmetic products to foreign countries 

that require export certificates. 

FDA estimates the burden of this 

collection of information as follows: 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 135 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent FDA Form No.2 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Cosmetics ........................... FDA 3613d ......................... 270 3 810 0.5 405 

Food .................................... FDA 3613e, 3613g, 3613l .. 881 5 4,405 0.5 2,203 

Total ............................. ............................................. ........................ ........................ ........................ ........................ 2,608 

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

2All forms are submitted electronically via the Certificate Application Process (CAP). 

We have revised the currently 

approved burden estimate for the 

information collection to reflect the 

elimination of paper-based forms. 

Specifically, and based on our 

experience with the information 

collection, we have reduced the 

estimated time to prepare a submission 

from 1.5 hours to 0.5 hour. The previous 

estimate was based on the time 

necessary to prepare a paper 

submission, but all firms requesting 

export certificates now provide 

submissions electronically via CAP. We 

believe that the time to prepare an 

electronic submission is under 0.25 

hour, but are estimating 0.5 hour as a 

conservative approach to address all 

scenarios. We base our estimates of the 

total annual responses on our 

experience with certificate applications 

received in the past 3 fiscal years. 

We expect that most firms requesting 

export certificates in the next 3 years 

will choose to take advantage of the 

option of electronic submission via 

CAP. If a firm is unable to submit their 

information via CAP, they may contact 

CFSAN and request assistance. CFSAN 

will assist firms in entering their 

information into the electronic system 

so that the firm may receive their export 

certificates in a timely manner. Our 

burden estimates in Table 1 are based 

on the expectation of 100 percent 

participation in the electronic 

submission process. Providing the 

opportunity to submit the information 

in electronic format has reduced our 

previous estimates for the time to 

prepare each submission. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28258 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; 

Neuroendocrinology, Neuroimmunology, 

Rhythms and Sleep Study Section. 

Date: February 1–2, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: New Orleans Marriott, 555 Canal 

Street, New Orleans, LA 70130. 

Contact Person: Michael Selmanoff, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5164, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1119, mselmanoff@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group; Macromolecular Structure 

and Function A Study Section. 

Date: February 1–2, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Dallas Downtown, 

1015 Elm Street, Dallas, TX 75202. 

Contact Person: David R. Jollie, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4166, 

MSC 7806, Bethesda, MD 20892, (301)–408– 

9072, jollieda@csr.nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Medical Imaging 

Study Section. 

Date: February 1–2, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Catamaran Resort, 3999 Mission 

Boulevard, San Diego, CA 92109. 

Contact Person: Xiang-Ning Li, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5112, 

MSC 7854, Bethesda, MD 20892, 301–435– 

1744, lixiang@csr.nih.gov. 

Name of Committee: Population Sciences 

and Epidemiology Integrated Review Group; 

Social Sciences and Population Studies A 

Study Section. 

Date: February 1, 2018. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Marines’ Memorial Club & Hotel, 

609 Sutter Street, San Francisco, CA 94102. 

Contact Person: Suzanne Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

1712, ryansj@csr.nih.gov. 

Name of Committee: Vascular and 

Hematology Integrated Review Group; 

Atherosclerosis and Inflammation of the 

Cardiovascular System Study Section. 

Date: February 1–2, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Delfina Santa Monica 

Hotel, 530 West Pico Boulevard, Santa 

Monica, CA 90405. 

Contact Person: Natalia Komissarova, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5207, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1206, komissar@mail.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 

Group; Developmental Therapeutics Study 

Section. 

Date: February 1–2, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Bayside, 4875 North 

Harbor Drive, San Diego, CA 92106. 

Contact Person: Sharon K. Gubanich, 

Ph.D., Scientific Review Officer, Center for 


daltland on DSKBBV9HB2PROD with NOTICES