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 


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Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41079 

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 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy 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 ’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002 or the 

Office of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Joann Belt, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3658, Silver Spring, 

MD 20993–0002, exportcert@

cdrh.fda.gov, 301–796–7400, option 3; 

or Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this draft guidance to 

comply with section 704 of FDARA 

(Pub. L. 115–52), which amended 

section 801 of the FD&C Act, to specify 

the process afforded to persons denied 

a CFG for a device. This draft guidance 

describes the information that CDRH 

and 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 applies to the process for 

persons denied CFGs requested 

pursuant to section 801(e)(4)(A) of the 

FD&C Act (21 U.S.C. 381(e)(4)(A) for 

devices manufactured in an 

establishment registered under section 

510 of the FD&C Act (21 U.S.C. 360) 

(i.e., FDA-approved, cleared, or 

exempted devices) that are exported 

from the United States. This draft 

guidance supplements the FDA’s 

guidance ‘‘FDA Export Certificates,’’ 

which is available at: https://

www.fda.gov/RegulatoryInformation/ 

Guidances/ucm125789.htm. This draft 

guidance is not final nor is it in effect 

at this time. 

II. Significance of Guidance 

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 the process for persons denied a 

certificate to foreign government for a 

device. 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. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

CDRH guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. This 

guidance document is also available at 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘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’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 17044 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information. These collections of 

information 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 sections 

801(e) and 802 (21 U.S.C. 382) of the 

FD&C Act have been approved under 

OMB control number 0910–0498; the 

collections of information in 21 CFR 

part 807, subparts A through E, have 

been approved under OMB control 

number 0910–0625; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; and the collections 

of information in the guidance ‘‘Center 

for Devices and Radiological Health 

Appeals Processes’’ have been approved 

under OMB control number 0910–0738. 

Dated: August 13, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17796 Filed 8–16–18; 8:45 am] 

BILLING CODE 4164–01–P 


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