Document ID: FDA-2013-N-1429-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Posted Date: 2013-12-04T05:00Z

[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72899-72900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28962]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]

Draft Guidance for Industry on Registration for Human Drug 
Compounding Outsourcing Facilities Under Section 503B of the Federal 
Food, Drug, and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Registration for Human Drug Compounding Outsourcing Facilities Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft 
guidance addresses new provisions in the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as amended by the Drug Quality and 
Security Act (DQSA). The draft guidance is intended to assist human 
drug compounders that choose to register as outsourcing facilities 
(outsourcing facilities) in registering with FDA. The draft guidance 
provides information on how an outsourcing facility should submit 
facility registration information electronically.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 3, 2014. Submit either electronic or written 
comments concerning the collection of information proposed in the draft 
guidance by February 3, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Soo Jin Park, Drug Registration and 
Listing Team, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-3100.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Registration for Human Drug Compounding Outsourcing 
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' The draft guidance is being issued to implement new provisions 
added to the FD&C Act in the DQSA. In the newly enacted legislation, 
Congress created a new statutory category of ``outsourcing facilities'' 
that compound human drugs. New section 503B of the FD&C Act (21 U.S.C. 
353b) allows compounders to register with FDA as outsourcing 
facilities. The draft guidance discusses the process for registration 
of outsourcing facilities.
    The 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 Agency's current thinking on registration 
for outsourcing facilities under section 503B of the FD&C Act. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.
    Elsewhere in this issue of the Federal Register, the Agency is 
making available for comment a draft guidance on interim product 
reporting for human drug compounding outsourcing facilities under 
section 503B of the FD&C Act.

II. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
document, FDA invites comments on the following topics: (1) Whether the 
proposed information collected is necessary for the proper performance 
of FDA's functions, including whether the information will have 
practical utility; (2) the accuracy of FDA's estimated burden of the 
proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Under the draft guidance, 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, within the next 
calendar year, drugs that appear on FDA's drug shortage list in effect 
under section 506E of the FD&C Act (21 U.S.C. 356e); and
     An indication of whether the facility compounds from bulk 
drug substances, and if so, whether it compounds sterile drugs from 
bulk drug substances.
    After initial registration, outsourcing facilities should register 
annually between October 1 and December 31 of each year. 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.'' 
FDA is also providing an alternative interim registration mechanism for 
use after initial passage of the DQSA because registration is a new 
requirement for those outsourcing facilities that elect to register 
under section 503B and because FDA wants to encourage registration of 
outsourcing

[[Page 72900]]

facilities. This alternative interim registration method relies on 
email and is only intended for use in the near term while outsourcing 
facilities unfamiliar with registration familiarize themselves with the 
SPL format. FDA encourages outsourcing facilities that choose to use 
this alternative interim method to begin using the SPL format no later 
than September 30, 2014. In addition, outsourcing facilities may 
request a waiver from the electronic submission process by submitting a 
written request to FDA explaining why the use of electronic means is 
not reasonable.
    Because human drug compounders are not currently required to 
register and report as outsourcing facilities, it is difficult to 
anticipate the number of outsourcing facilities that will participate 
in the process.
    Estimated reporting burden until September 30, 2014. We estimate 
that approximately 15 outsourcing facilities (``number of respondents'' 
and ``total responses'' in table 1 row 1) will submit registration 
information to FDA using email as specified in the draft guidance, and 
that preparing and submitting this information will take approximately 
15 minutes (``average burden per response'' in table 1 row 1). We also 
estimate that approximately 5 outsourcing facilities (``number of 
respondents'' and ``total responses'' in table 1, row 2) will submit to 
FDA registration information using the SPL format as specified in the 
draft guidance, and that preparing and submitting this information will 
take approximately 4.5 hours per registrant (``average burden per 
response'' in table 1, row 2). We expect to receive no more than one 
waiver request from the electronic submission process during this time 
period (``number of respondents'' and ``total responses'' in table 1, 
row 3), and that each request should take approximately 1 hour to 
prepare and submit to us (``average burden per response'' in table 1, 
row 3).
    Estimated annual reporting burden after September 30, 2014. We 
estimate that approximately 20 outsourcing facilities (``number of 
respondents'' and ``total annual responses'' in table 2, row 1) will 
annually submit to FDA registration information using the SPL format as 
specified in the draft guidance, and that preparing and submitting this 
information will take approximately 4.5 hours per registrant (``average 
burden per response'' in table 2, 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 2, 
row 2), and that each request should take approximately 1 hour to 
prepare and submit to us (``average burden per response'' in table 2, 
row 2).

                        Table 1--Estimated Reporting Burden Until September 30, 2014 \1\
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                                                     Number of
Compounding outsourcing facility     Number of     responses per       Total      Average burden    Total hours
                                    respondents     respondent       responses     per response
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Alternative Interim Registration              15               1              15            0.25            3.75
 Method Using Email.............
Electronic Submission of                       5               1               5             4.5           22.50
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           27.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                     Table 2--Estimated Annual Reporting Burden After September 30, 2014 \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
----------------------------------------------------------------------------------------------------------------
Electronic Submission of                      20               1              20             4.5              90
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              91
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28962 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P