
[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69857-69859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1428]


Electronic Product Reporting for Human Drug Compounding 
Outsourcing Facilities; Draft Guidance

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announcing the availability of a revised draft guidance entitled 
``Electronic Product Reporting for Human Drug Compounding Outsourcing 
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' The revised draft guidance addresses provisions in the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality 
and Security Act (DQSA) and updates reporting instructions for drug 
compounders that choose to register as outsourcing facilities. Such 
compounders must report information on the drugs they have compounded 
in Structured Product Labeling (SPL) format using FDA's electronic 
submissions system. This revised draft guidance supersedes a draft 
guidance entitled ``Interim Product Reporting for Human Drug 
Compounding Outsourcing Facilities Under Section 503B of the Federal 
Food, Drug, and Cosmetic Act.''

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 comments on 
this revised draft guidance, submit either electronic or written 
comments on the revised draft guidance by January 23, 2015. Submit 
either electronic or written comments concerning the collection of 
information proposed in the revised draft guidance by January 23, 2015.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance document to the Division of Drug Information, Center for 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 request. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the revised draft guidance.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov.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: Lysette Deshields, 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 revised draft guidance for 
industry entitled ``Electronic Product Reporting for Human Drug 
Compounding Outsourcing Facilities Under Section 503B of the Federal 
Food, Drug, and Cosmetic Act.'' In the Federal Register of December 4, 
2013 (78 FR 72897), FDA issued a notice announcing the availability of 
an initial draft of this guidance entitled ``Interim Product Reporting 
for Human Drug Compounding Outsourcing Facilities Under Section 503B of 
the Federal Food, Drug, and Cosmetic Act.'' That draft guidance 
addressed new provisions in the FD&C Act added by the DQSA and set 
forth an interim submission method for human drug compounders that 
choose to register as outsourcing facilities.
    The comment period on the initial draft guidance ended on February 
3, 2014. FDA received six comments on the draft. In response to 
received comments or on its own initiative, FDA made the following 
changes and updates in the revised draft guidance: (1) Modified the 
scope of the guidance to refer to product reports submitted in SPL 
format; (2) clarified the following elements required in a product 
report: ``Strength of the active ingredient per unit,'' ``package 
description,'' and

[[Page 69858]]

``number of individual units produced''; (3) included language that 
discusses the time period during which outsourcing facilities must 
submit product reports; (4) included the appropriate SPL document type 
category for outsourcing facilities submitting a product report and a 
reference to detailed instructions on how to submit information using 
SPL; (5) clarified that reports submitted under section 503B(b)(2) of 
the FD&C Act (21 U.S.C. 353b(b)(2)) are exempt from inspection unless 
the Secretary finds that such an exemption would be inconsistent with 
the protection of the public health; and (6) made grammatical and other 
minor editorial changes for clarity.
    In some cases, received comments raised issues that were not 
directly pertinent to the topics addressed in the draft. This revised 
draft guidance explains that registered outsourcing facilities must 
provide reports to FDA on compounded drugs in SPL format using FDA's 
electronic submissions system. It supersedes the draft guidance 
entitled ``Interim Product Reporting for Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.''
    Section 503B(b)(2)(B) of the FD&C Act provides that a facility that 
elects to register with FDA as an outsourcing facility is required to 
report to FDA information about the drugs compounded at that 
outsourcing facility in the form and manner as FDA may ``prescribe by 
regulation or guidance.'' Congress gave FDA explicit statutory 
authority to establish binding requirements on this topic in guidance. 
Therefore, this guidance is not subject to the usual restrictions in 
FDA's good guidance practice regulations (e.g., the requirements that 
guidances not establish legally enforceable responsibilities and that 
guidances prominently display a statement of the document's nonbinding 
effect); see 21 CFR 10.115(d)(1)).
    As provided in section 503B of the DQSA, this revised draft 
guidance explains the form and manner in which registered outsourcing 
facilities are required to submit drug reporting information. This 
revised draft guidance, when finalized, will prescribe the form and 
manner for submitting drug product reports to FDA under section 503B of 
the FD&C Act and will have binding effect under section 503B(b)(2)(B). 
Until this draft guidance is finalized, FDA will accept drug product 
reports submitted in accordance with the form and manner described in 
FDA's initial draft guidance on this subject. However, FDA strongly 
encourages outsourcing facilities to submit drug product reports as 
described in this revised draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is making 
available a final guidance on registration 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 revised draft guidance, registered outsourcing facilities 
must submit to FDA a report identifying all drugs compounded by the 
facility during the previous 6-month period. The report must be 
submitted upon initial registration as an outsourcing facility, once in 
June, and once in December of each year. The report must include the 
following information for all drugs compounded at the outsourcing 
facility during the previous 6-month period:
     The active ingredient and strength of active ingredient 
per unit
     The source of the active ingredient (bulk or finished)
     The National Drug Code (NDC) number of the source drug or 
bulk active ingredient, if available
     The dosage form and route of administration
     The package description
     The number of individual units produced
     The NDC number of the final product, if assigned
    Product reports must be submitted to FDA electronically in SPL 
format, as described in the revised draft guidance. Outsourcing 
facilities can 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 for them.
    Based on our familiarity with outsourcing facilities, we estimate 
that annually a total of approximately 50 outsourcing facilities 
(``number of respondents'' in table 1, row 1) will submit to FDA at the 
time of initial registration a report identifying all drugs compounded 
in the facility. We also estimate that these outsourcing facilities 
will submit a total of approximately 50 reports for compounded drugs 
containing the information specified in the draft guidance (``total 
annual responses'' in table 1, row 1). We estimate that preparing and 
submitting this information electronically will take approximately 2 
hours per report (``average burden per response'' in table 1, row 1). 
We expect to receive no more than one waiver request from this 
electronic submission process (``total annual responses'' in table 1, 
row 2), and each request should take approximately 1 hour to prepare 
and submit to us (``average burden per response'' in table 1, row 2).
    We also estimate that a total of approximately 50 outsourcing 
facilities (``number of respondents'' in table 2, row 1) will submit to 
FDA a report twice each year identifying all drugs compounded at the 
facility. We estimate that these outsourcing facilities will submit a 
total of approximately 50 reports in December and 50 reports in June 
containing the information specified in the draft revised guidance 
(``total annual responses'' in table 2, row 1). We estimate that 
preparing and submitting this information electronically will take 
approximately 2 hours per report (``average burden per response'' in 
table 2, row 1). We expect to receive no more than one waiver request 
from the electronic submission process (``total annual responses'' in 
table 2, row 2), and each request should take approximately 1 hour to 
prepare and submit to us (``average burden per response'' in table 2, 
row 2).

[[Page 69859]]



                                Table 1--Estimated One-Time Reporting Burden \1\
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      Product reporting for                          Number of                        Average
     compounding outsourcing         Number of     responses per   Total annual     burden per      Total hours
           facilities               respondents     respondent       responses       response
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Submission of Initial Product                 50               1              50               2             100
 Report.........................
Waiver Request from Electronic                 1               1               1               1               1
 Submission of Initial Product
 Report.........................
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    Total.......................  ..............  ..............  ..............  ..............             101
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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 \1\
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      Product reporting for                          Number of
     compounding outsourcing         Number of     responses per   Total annual   Average burden    Total hours
           facilities               respondents     respondent       responses     per response
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Submission of December Product                50               1              50               2             100
 Report.........................
Submission of June Product                    50               1              50               2             100
 Report.........................
Waiver Request from Electronic                 1               1               1               1               1
 Submission of Product Reports..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             201
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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 can 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 
can be viewed at 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 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27691 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P


