Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48093 

comment on the proposed collection of 

information. No comments were 

received. 

We therefore estimate the burden 

associated with the information 

collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Compounding outsourcing facility Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Electronic Submission of Registration Information Using 

SPL Format ...................................................................... 62 1 62 4.5 279 

Waiver Request From Electronic Submission of Registration Information ................................................................. 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 280 

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

We estimate that approximately 62 

outsourcing facilities (‘‘number of 

respondents’’ and ‘‘total annual 

responses’’ in table 1, row 1) will 

annually submit to FDA registration 

information using the SPL format as 

specified in the guidance, and that 

preparing and submitting this 

information will take approximately 4.5 

hours per registrant (‘‘average burden 

per response’’ in table 1, row 1). We 

expect to receive no more than one 

waiver request from the electronic 

submission process annually (‘‘number 

of respondents’’ and ‘‘total annual 

responses’’ in table 1, row 2), and that 

each request should take approximately 

1 hour to prepare and submit to us 

(‘‘average burden per response’’ in table 

1, row 2). 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22284 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5226] 

Department of Health and Human 

Services, Supply Service Center et al.; 

Withdrawal of Approval of 27 

Abbreviated New Drug Applications; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

entitled ‘‘Department of Health and 

Human Services, Supply Service Center 

et al.; Withdrawal of Approval of 27 

Abbreviated New Drug Applications’’ 

that appeared in the Federal Register of 

September 21, 2017 (82 FR 44185). The 

document announced the withdrawal of 

approval of 27 abbreviated new drug 

applications (ANDAs) from multiple 

applicants. The document was 

published with the incorrect docket 

number. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 3330, Silver Spring, 

MD 20993–0002, 301–796–9115, 

lisa.granger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Thursday, 

September 21, 2017, in FR Doc. 2017– 

20107, on page 44185 the following 

correction is made: 

On page 44185, in the second column, 

under the docket number FDA–2017–N– 

5526 is corrected to read ‘‘FDA–2017– 

N–5226’’. 

Dated: October 11, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22299 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5928] 

Post-Complete Response Letter 

Meetings Between the Food and Drug 

Administration and Abbreviated New 

Drug Application Applicants Under the 

Generic Drug User Fee Act; Draft 

Guidance for Industry; 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 a draft 

guidance for industry entitled ‘‘PostComplete Response Letter Meetings 

Between FDA and ANDA Applicants 

Under GDUFA.’’ This guidance is 

intended to clarify the criteria for 

granting post-complete response letter 

(CRL) meeting requests and the scope of 

discussions for granted meeting 

requests. This guidance provides 

procedures that will promote wellmanaged post-CRL meetings and help 

ensure that such meetings are scheduled 

and conducted in accordance with the 

time frames set forth in the GDUFA 

Reauthorization Performance Goals and 

Program Enhancements Fiscal Years 

2018–2022 (GDUFA II Goals or 

Commitment Letter). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 15, 2017 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 


ethrower on DSK3G9T082PROD with NOTICES
48094 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

1Available at http://www.fda.gov/downloads/ 

ForIndustry/UserFees/GenericDrugUserFees/ 

UCM525234.pdf. 

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– 

2017–D–5928 for ‘‘Post-Complete 

Response Letter Meetings Between FDA 

and ANDA Applicants Under GDUFA; 

Draft Guidance for Industry; 

Availability.’’ 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 

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)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Tamara R. Coley, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Building 75, Rm. 1668, 

Silver Spring, MD 20903, 240–402– 

6903. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Post-Complete Response Letter 

Meetings Between FDA and ANDA 

Applicants Under GDUFA.’’ The 

Generic Drug User Fee Amendments of 

2017 (GDUFA II), reauthorizing generic 

drug user fees for Fiscal Years 2018– 

2022, was signed into law on August 18, 

2017, to facilitate timely access to 

quality, affordable generic medicines. In 

accordance with the GDUFA II 

Commitment Letter 1 that accompanied 

the legislation, FDA agreed to certain 

review goals and procedures for the 

review of post-CRL meetings received 

on or after October 1, 2017. 

The GDUFA II Commitment Letter 

adds time frames within which FDA 

will provide a scheduled date for, and 

will conduct, post-CRL meetings. Under 

GDUFA I, FDA committed to close out 

a certain number of teleconference 

requests in fiscal year (FY) 2015 through 

FY 2017. In accordance with the 

GDUFA II Commitment Letter, FDA 

committed to schedule and conduct 90 

percent of post-CRL meetings within 

prescribed time frames. 

As described in the GDUFA II 

Commitment Letter, post-CRL meetings 

will be used by applicants ‘‘to seek 

clarification concerning deficiencies 

identified in a CRL.’’ Under GDUFA II, 

post-CRL meetings are available for both 

major and minor CRLs and for first and 

subsequent review cycles. FDA will 

grant any complete post-CRL meeting 

request that satisfies the criteria 

outlined in section IV. FDA will only 

grant post-CRL meeting requests that 

pose questions to clarify identified 

deficiencies. Other issues, including 

questions requiring further Agency 

review, disputes about classification of 

complete response amendments, or new 

information submitted by the applicant, 

will not be addressed in a post-CRL 

meeting. 

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 ‘‘Post-Complete Response Letter 

Meetings Between FDA and ANDA 

Applicants Under GDUFA.’’ 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 found in FDA regulations. 

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 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48095 

Dated: October 3, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22288 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0094] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Channels of Trade 

Policy for Commodities With Residues 

of Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by November 

15, 2017. 

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 0910–0562. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Channels of Trade Policy for 

Commodities With Residues of 

Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

OMB Control Number 0910–0562— 

Extension 

The Food Quality Protection Act of 

1996, which amended the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) and the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), 

established a new safety standard for 

pesticide residues in food, with an 

emphasis on protecting the health of 

infants and children. The 

Environmental Protection Agency (EPA) 

is responsible for regulating the use of 

pesticides (under FIFRA) and for 

establishing tolerances or exemptions 

from the requirement for tolerances for 

residues of pesticide chemicals in food 

commodities (under the FD&C Act). 

EPA may, for various reasons, e.g., as 

part of a systematic review or in 

response to new information concerning 

the safety of a specific pesticide, 

reassess whether a tolerance for a 

pesticide residue continues to meet the 

safety standard in section 408 of the 

FD&C Act (21 U.S.C. 346a). When EPA 

determines that a pesticide’s tolerance 

level does not meet that safety standard, 

the registration for the pesticide may be 

canceled under FIFRA for all or certain 

uses. In addition, the tolerances for that 

pesticide may be lowered or revoked for 

the corresponding food commodities. 

Under section 408(l)(2) of the FD&C Act, 

when the registration for a pesticide is 

canceled or modified due to, in whole 

or in part, dietary risks to humans posed 

by residues of that pesticide chemical 

on food, the effective date for the 

revocation of such tolerance (or 

exemption in some cases) must be no 

later than 180 days after the date such 

cancellation becomes effective or 180 

days after the date on which the use of 

the canceled pesticide becomes 

unlawful under the terms of the 

cancellation, whichever is later. 

When EPA takes such actions, food 

derived from a commodity that was 

lawfully treated with the pesticide may 

not have cleared the channels of trade 

by the time the revocation or new 

tolerance level takes effect. The food 

could be found by FDA, the Agency that 

is responsible for monitoring pesticide 

residue levels and enforcing the 

pesticide tolerances in most foods (the 

U.S. Department of Agriculture has 

responsibility for monitoring residue 

levels and enforcing pesticide tolerances 

in egg products and most meat and 

poultry products), to contain a residue 

of that pesticide that does not comply 

with the revoked or lowered tolerance. 

We would normally deem such food to 

be in violation of the law by virtue of 

it bearing an illegal pesticide residue. 

The food would be subject to FDA 

enforcement action as an ‘‘adulterated’’ 

food. However, the channels of trade 

provision of the FD&C Act addresses the 

circumstances under which a food is not 

unsafe solely due to the presence of a 

residue from a pesticide chemical for 

which the tolerance has been revoked, 

suspended, or modified by EPA. The 

channels of trade provision (section 408 

(l)(5) of the FD&C Act) states that food 

containing a residue of such a pesticide 

shall not be deemed ‘‘adulterated’’ by 

virtue of the residue, if the residue is 

within the former tolerance, and the 

responsible party can demonstrate to 

FDA’s satisfaction that the residue is 

present as the result of an application of 

the pesticide at a time and in a manner 

that were lawful under FIFRA. 

In the Federal Register of May 18, 

2005 (70 FR 28544), we announced the 

availability of a guidance document 

entitled ‘‘Channels of Trade Policy for 

Commodities With Residues of Pesticide 

Chemicals, for Which Tolerances Have 

Been Revoked, Suspended, or Modified 

by the Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations.’’ The guidance 

represents FDA’s current thinking on its 

planned enforcement approach to the 

channels of trade provision of the FD&C 

Act and how that provision relates to 

FDA-regulated products with residues 

of pesticide chemicals for which 

tolerances have been revoked, 

suspended, or modified by EPA under 

dietary risk considerations. The 

guidance can be found at the following 

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

GuidanceRegulation/ 

GuidanceDocuments

RegulatoryInformation/ 

ChemicalContaminantsMetalsNatural

ToxinsPesticides/ucm077918.htm. We 

anticipate that food bearing lawfully 

applied residues of pesticide chemicals 

that are the subject of future EPA action 

to revoke, suspend, or modify their 

tolerances, will remain in the channels 

of trade after the applicable tolerance is 

revoked, suspended, or modified. If we 

encounter food bearing a residue of a 

pesticide chemical for which the 

tolerance has been revoked, suspended, 

or modified, we intend to address the 

situation in accordance with provisions 

of the guidance. In general, we 

anticipate that the party responsible for 

food found to contain pesticide 


ethrower on DSK3G9T082PROD with NOTICES