48092 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

As described in section III.D of the 

guidance, those outsourcing facilities 

that request a small business reduction 

in the amount of the annual 

establishment fee will receive a small 

business designation letter notifying the 

facility of FDA’s decision. Outsourcing 

facilities eligible to pay a reduced fee 

should maintain a copy of the small 

business designation letter applicable to 

that fiscal year for their records. 

We estimate that annually a total of 15 

outsourcing facilities (‘‘no. of 

recordkeepers’’ in table 3) will keep a 

copy of their small business designation 

letter (‘‘total annual records’’ in table 3), 

and that maintaining each record will 

take 0.5 hour (‘‘average burden per 

recordkeeping’’ in table 3). 

As described in section V.B of the 

guidance, an outsourcing facility may 

request reconsideration under 21 CFR 

10.75 of an FDA decision related to the 

fee provisions of section 744K of the 

FD&C Act. As explained in the 

guidance, the request should state the 

facility’s rationale for its position that 

the decision was in error and include 

any additional information that is 

relevant to the outsourcing facility’s 

argument. 

We estimate that a total of three 

outsourcing facilities (‘‘no. of 

respondents’’ in table 2, row 2) annually 

will submit to FDA a request for 

reconsideration as described in the 

guidance. We estimate that it will take 

an outsourcing facility approximately 1 

hour to prepare and submit to FDA each 

request for reconsideration (‘‘average 

burden per response’’ in table 2, row 2). 

As described in section V.B of the 

guidance, an outsourcing facility may 

appeal, as set forth in § 10.75, an FDA 

denial of a request for reconsideration of 

an FDA decision related to the fee 

provisions of section 744K of the FD&C 

Act. 

We estimate that a total of one 

outsourcing facility (‘‘no. of 

respondents’’ in table 2, row 3) annually 

will submit an appeal of an FDA denial 

of a request for reconsideration. We 

estimate that it will take an outsourcing 

facility 1 hour to prepare and submit 

each appeal under § 10.75 (‘‘average 

burden per response’’ in table 2, row 3). 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22283 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–2013–N–1429] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Registration of Human 

Drug Compounding Outsourcing 

Facilities Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act 

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. 

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 0910–0777. 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–12M, 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 on Registration 

of Human Drug Compounding 

Outsourcing Facilities Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act OMB Control Number 

0910–0777—Extension 

This information collection supports 

the above captioned Agency guidance. 

A facility that compounds drugs may 

elect to register with FDA as an 

outsourcing facility under section 503B 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 353b), as 

added by the Drug Quality and Security 

Act (DQSA). Drug products 

compounded in a registered outsourcing 

facility can qualify for exemptions from 

the FDA approval requirements in 

section 505 of the FD&C Act (21 U.S.C. 

355), the requirement to label products 

with adequate directions for use under 

section 502(f)(1) of the FD&C Act (21 

U.S.C. 352(f)(1)), and drug supply chain 

security requirements in section 582 of 

the FD&C Act (21 U.S.C. 360eee) if the 

requirements in section 503B of the 

FD&C Act are met. 

After the initial registration, under 

section 503B(b) of the FD&C Act, a 

facility that elects to register with FDA 

as an outsourcing facility must also do 

so annually between October 1 and 

December 31. Upon registration, the 

outsourcing facility must provide its 

name, place of business, a unique 

facility identifier, and a point of contact 

email address and phone number. The 

outsourcing facility must also indicate 

whether it intends to compound, within 

the next calendar year, a drug that 

appears on FDA’s drug shortage list in 

effect under section 506E of the FD&C 

Act (21 U.S.C. 356e), and whether it 

compounds from bulk drug substances, 

and, if so, whether it compounds sterile 

or non-sterile drugs from bulk drug 

substances. 

Outsourcing facilities that elect to 

register should submit the following 

registration information to FDA for each 

facility: 

• Name of the facility; 

• Place of business; 

• Unique facility identifier; 

• Point of contact email address and 

phone number; 

• Whether the facility intends to 

compound drugs that appear on FDA’s 

drug shortage list in effect under section 

506E of the FD&C Act; and 

• An indication of whether the 

facility compounds from bulk drug 

substances, and if so, whether it 

compounds sterile or nonsterile drugs 

from bulk drug substances. 

Registration information should be 

submitted to FDA electronically using 

the Structured Product Labeling (SPL) 

format and in accordance with section 

IV of the FDA guidance entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Drug Establishment 

Registration and Drug Listing.’’ Under 

the final guidance, outsourcing facilities 

may request a waiver from the SPL 

electronic submission process by 

submitting a written request to FDA 

explaining why the use of electronic 

means is not reasonable. 

In the Federal Register of June 20, 

2017 (82 FR 28076), FDA published a 

60-day notice requesting public 


ethrower on DSK3G9T082PROD with NOTICES
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 


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