Document ID: FDA-2013-N-1429-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of Federal Food, Drug, and Cosmetic Act
Posted Date: 2017-10-16T04:00Z

[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48092-48093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22284]

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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.

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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

[[Page 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 Burden\1\
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                                                     Number of
Compounding outsourcing facility     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Electronic Submission of                      62               1              62             4.5             279
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
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    Total.......................  ..............  ..............  ..............  ..............             280
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\1\ There 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