48090 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Application ....................................................................................................... 52 1 40 2,080

Annual Report .................................................................................................. 52 1 24 1,248 

Estimated Total Annual Burden 

Hours: 3,328. 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 330 C Street SW., 

Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. Email 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on (a) whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Mary Jones, 

ACF/OPRE Reports Clearance Officer. 

[FR Doc. 2017–22294 Filed 10–13–17; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0329] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Fees for Human Drug 

Compounding Outsourcing Facilities 

Under 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 0910–0776. 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, 10A63, 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 Fees for 

Human Drug Compounding 

Outsourcing Facilities Under Sections 

503B and 744K of the FD&C Act OMB 

Control Number 0910–0776—Extension 

This information collection supports 

the Agency’s guidance on fees for 

human drug compounding outsourcing 

facilities under the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act). On 

November 27, 2013, the President 

signed the Drug Quality and Security 

Act (DQSA) (Pub. L. 113–54) into law. 

The DQSA added a new section, 503B 

(21 U.S.C. 353B), to the FD&C Act, 

creating a category of entities called 

‘‘outsourcing facilities.’’ Outsourcing 

facilities, as defined in section 

503B(d)(4) of the FD&C Act, are 

facilities that meet certain requirements 

described in section 503B, including 

registering with FDA as an outsourcing 

facility and paying associated fees. Drug 

products compounded in an 

outsourcing facility can qualify for 

exemptions from the FDA approval 

requirements in section 505 of the FD&C 

Act (21 U.S.C. 355), and 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)), if the requirements in section 

503B of the FD&C Act are met. 

The guidance is intended for entities 

that compound human drugs and elect 

to register as outsourcing facilities 

under section 503B of the FD&C Act. 

Once an entity has elected to register as 

an outsourcing facility, it must pay 

certain fees to be registered as an 

outsourcing facility. The guidance 

describes the types and amounts of fees 

that outsourcing facilities must pay, the 

adjustments to fees required by law, the 

way in which outsourcing facilities may 

submit payment to FDA, the 

consequences of outsourcing facilities’ 

failure to pay fees, and the way an 

outsourcing facility may qualify as a 

small business to obtain a reduction in 

fees. 

In the Federal Register of June 15, 

2017 (82 FR 27493), we published a 60- 

day notice requesting public comment 

on the proposed extension of this 

collection of information. No comments 

were received. We therefore estimate the 

burden associated with the information 

collection as follows: 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices 48091 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—ESTABLISHMENT FEE 1

Type of reporting Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Payment of annual establishment fee ........................... 60 1 60 .5 (30 minutes) 30 

Request for Small Business Establishment Fee Reduction (Form FDA 3908) ................................................ 15 1 15 25 375 

Total ........................................................................ ........................ ........................ ........................ .............................. 405 

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

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—RE-INSPECTION FEE AND DISPUTE RESOLUTION REQUESTS 1

Type of reporting Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Payment of re-inspection fee ......................................... 15 1 15 .5 (30 minutes) 7.50 

Reconsideration request ................................................ 3 1 3 1 3 

Appeal request ............................................................... 1 1 1 1 1 

Total ........................................................................ ........................ ........................ ........................ .............................. 11.50 

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

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

record per 

recordkeeper 

Total annual 

records 

Average 

burden per 

record 

Total hours 

Copy of small business designation letter ..................... 15 1 15 .5 (30 minutes) 7.50 

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

As described in section III.A of the 

guidance, upon receiving registration 

information from a facility seeking to 

register as an outsourcing facility, FDA 

will send an invoice for an 

establishment fee to the outsourcing 

facility. The invoice contains 

instructions for paying the 

establishment fee, as discussed in 

section III.E of the guidance. This 

process would be repeated annually 

under the timeframes described in the 

guidance. An outsourcing facility is not 

considered registered until the required 

establishment fee is paid for that fiscal 

year. 

We estimate that annually a total of 60 

outsourcing facilities (‘‘no. of 

respondents’’ in table 1, row 1) will pay 

to FDA 60 establishment fees (‘‘total 

annual responses’’ in table 1, row 1) as 

described in the guidance. We also 

estimate that it will take an outsourcing 

facility 0.5 hour to prepare and submit 

to FDA each establishment fee (‘‘average 

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

As described in section III.C of the 

guidance, outsourcing facilities that are 

re-inspected will be assessed a reinspection fee for each re-inspection. 

The re-inspection fee is designed to 

reimburse FDA when it must visit a 

particular outsourcing facility more than 

once because of noncompliance 

identified during a previous inspection. 

A re-inspection fee will be incurred for 

each re-inspection that occurs. After 

FDA conducts a re-inspection, we will 

send an invoice to the email address 

indicated in the facility’s registration 

file. The invoice contains instructions 

for paying the re-inspection fee, as 

discussed in section III.E of the 

guidance. 

We estimate that annually a total of 15 

outsourcing facilities (‘‘no. of 

respondents’’ in table 2, row 1) will pay 

to FDA 15 re-inspection fees (‘‘total 

annual responses’’ in table 2, row 1) as 

described in the guidance. We also 

estimate that it will take an outsourcing 

facility 0.5 hour to prepare and submit 

to FDA each re-inspection fee (‘‘average 

burden per response’’ in table 2, row 1). 

As described in section III.D of the 

guidance, certain outsourcing facilities 

may qualify for a small business 

reduction in the amount of the annual 

establishment fee. To qualify for this 

reduction, an outsourcing facility must 

submit to FDA a written request 

certifying that the entity meets the 

requirements for the reduction. For 

every fiscal year that the firm seeks to 

qualify as a small business and receive 

the fee reduction, the written request 

must be submitted to FDA by April 30 

of the preceding fiscal year. For 

example, an outsourcing facility must 

submit a written request for the small 

business reduction by April 30, 2015, to 

qualify for a reduction in the fiscal year 

2016 annual establishment fee. As 

described in the guidance, section 744K 

of the FD&C Act (21 U.S.C. 379j–62) also 

requires an outsourcing facility to 

submit its written request for a small 

business reduction in a format specified 

by FDA in the guidance. The guidance 

specifies that Form FDA 3908 is the 

format for submitting requests for a 

small business fee reduction. 

We estimate that annually a total of 15 

outsourcing facilities (‘‘no. of 

respondents’’ in table 1, row 2) will 

submit to FDA a request for a small 

business reduction in the amount of the 

annual establishment fee. We estimate 

that 15 outsourcing facilities will submit 

Form FDA 3908 (‘‘total annual 

responses’’ in table 1, row 2) to FDA 

annually, as described in the guidance, 

and that it will take an outsourcing 

facility 25 hours to prepare and submit 

to FDA each Form FDA 3908 (‘‘average 

burden per response’’ in table 1, row 2). 


ethrower on DSK3G9T082PROD with NOTICES
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 


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