[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72897-72899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Interim Product Reporting for 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announcing the availability of a draft guidance for industry entitled 
``Interim Product Reporting 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 The draft guidance addresses new provisions in the Federal Food, 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), and sets forth an interim electronic 
submission method for human drug compounders that choose to register as 
outsourcing facilities (outsourcing facilities).

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draft guidance before it begins work on a draft guidance describing the 
updated format for long-term use, submit either electronic or written 
comments on this draft guidance by February 3, 2014.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proposed in the draft guidance by February 3, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Lysette Deshields, 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 ``Interim Product Reporting 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 drugs. New section 503B of the FD&C Act (21 
U.S.C. 353b) allows compounders to register with FDA as outsourcing 
facilities and, among other things, imposes reporting requirements on 
these entities if they choose to register. The draft guidance is 
intended to assist registered outsourcing facilities in implementing 
drug reporting. The draft guidance describes how an outsourcing 
facility should provide interim electronic reports while FDA modifies 
its existing electronic drug registration and listing system to 
accommodate reporting of product information by registered outsourcing 
facilities under section 503B of the FD&C Act. When the Agency has 
modified its current electronic submission system to allow outsourcing 
facilities to submit information electronically through a Structured 
Product Labeling file, FDA intends to issue a draft guidance describing 
the updated format for long-term use. When such guidance is issued in 
final form, it will specify the form of reporting that outsourcing 
facilities are to follow from that point forward.
    The draft guidance 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 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 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)

[[Page 72898]]

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, registered outsourcing facilities should 
submit to FDA a report identifying all drugs compounded by the facility 
during the previous 6-month period. This product report should be 
submitted upon initial registration as an outsourcing facility and once 
during the months of June and December of each year. The report should 
include the following information for all drugs compounded by 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 
drug);
     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; and
     The NDC number of the final product, if assigned.
    Product reports should be submitted to FDA electronically using an 
Excel spreadsheet and via an email attachment, as described in the 
draft guidance. 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 required to register and 
report as outsourcing facilities, it is difficult to anticipate the 
number of outsourcing facilities that will participate in the process. 
We estimate that a total of approximately 20 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 
by the facility. We also estimate that these outsourcing facilities 
will submit a total of approximately 20 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 10 
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 20 outsourcing 
facilities (``number of respondents'' in table 2, row 1) will annually 
submit to FDA a report identifying all drugs compounded by the 
facility. We estimate that these outsourcing facilities will submit a 
total of approximately 20 reports in June and 20 reports in December 
containing the information specified in the draft guidance (``total 
annual responses'' in table 2, row 1). We estimate that preparing and 
submitting this information electronically will take approximately 10 
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).

                                Table 1--Estimated One-Time 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 Initial Product                 20               1              20              10             200
 Report.........................
Waiver Request from Electronic                 1               1               1               1               1
 Submission of Initial Product
 Report.........................
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    Total.......................  ..............  ..............  ..............  ..............             201
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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
----------------------------------------------------------------------------------------------------------------
Submission of June Product                    20               1              20              10             200
 Report.........................
Submission of December Product                20               1              20              10             200
 Report.........................
Waiver Request from Electronic                 1               1               1               1               1
 Submission of Product Reports..
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    Total.......................  ..............  ..............  ..............  ..............             401
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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.


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    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28960 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P