[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Notices]
[Pages 50523-50525]
[FR Doc No: 2016-18048]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Electronic Drug Product Reporting 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 August
31, 2016.

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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the title. Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown Street, North Bethesda, MD 20852<EMAIL_ADDRESS>
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: Electronic Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act; Availability--OMB Control Number 0910--
(NEW)

    On November 27, 2013, the President signed the Drug Quality and
Security Act (DQSA) into law (Pub. L. 113-54).

The DQSA added a new section 503B to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353b). Under section 503B(b), a
compounder can register as an outsourcing facility with FDA. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications or abbreviated new drug
applications. Drugs compounded in outsourcing facilities are not exempt
from the requirements of section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice
for drugs).
    In the Federal Register of November 24, 2014 (79 FR 69857), FDA
announced the availability of a revised draft guidance for industry
entitled ``Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' Under section 503B of the FD&C Act, and as
described in the revised draft guidance, an outsourcing facility must,
at the time of initial registration and twice each year, in June and
December, submit to FDA a report identifying the drugs compounded by
the facility during the previous six-month period. For each identified
drug, the outsourcing facility must provide certain information, which
is listed in section 503B(b)(2)(A)(ii) of the FD&C Act and in the
revised draft guidance.
    Each facility that elects to register as an outsourcing facility
must report the following information to FDA for each product that it
compounds:
     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.
    Compounded product information must 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,'' available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064994.htm. Under
the revised draft 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 for the person requesting the waiver.
    In response to the November 24, 2014, Federal Register notice, FDA
received three comments on the revised draft guidance. Comments that
addressed the information collection provisions are identified and
discussed here.
    One comment expressed concern about being unable to submit a
product report within the required 30-day reporting period because of
the extensive amount of time to create a product report, especially for
facilities with large product portfolios. The comment suggested that
FDA did not recognize that each outsourcing facility will have numerous
SPL entries into the electronic reporting system to make up a product
report.
    In consideration of the comment, we have increased our burden
estimate as reflected in the tables 1 and 2. We have also explained in
the guidance that there are ways to simplify the submission of product
reporting information and reduce the number of responses and total
burden of submitting product reporting information.
    Initially, the creation of product report submissions can be time
consuming, but submissions can be saved, updated, and resubmitted for
subsequent reporting periods instead of creating a new submission each
time. In addition, multiple strengths of the same drug, package sizes,
and source NDC numbers can be consolidated into a single product
submission in SPL.
    Based on current data for outsourcing facilities, we estimate
approximately 55 outsourcing facilities will submit to FDA an initial
report identifying all drugs compounded in the facility in the previous
6 months. By our calculation, each product's SPL submission is
considered a separate response and therefore each facility's product
report will include multiple responses. Taking into account that a
particular product that is compounded into different strengths from
different sources of active ingredient can be reported in a single SPL
response, we estimate that the number of products reported per facility
will average 220 products per facility. This estimate is based on
current data in product reports.
    Concerning the comment that each outsourcing facility will have
numerous SPL entries, again we have revised our previous estimate to
account for the fact that each product report will consist of multiple
SPL responses per facility. We estimate that preparing and submitting
this information electronically could take up to approximately 2 hours
for each initial SPL response.
    We also estimate that approximately 55 outsourcing facilities will
submit to FDA a report twice each year identifying all drugs compounded
at the facility in the previous 6 months. As described previously, we
estimate on average 220 SPL responses per facility. We estimate that
preparing and submitting this information electronically will take
approximately one half hour per response. At the same time, we have
reduced the burden for semi-annual product submissions reasoning that
outsourcing facilities can save each SPL response once initially
created and submitted. For subsequent reports, an outsourcing facility
may resubmit the same file(s) after changing only the following data
elements to appropriate values for the reporting period (along with
other data as appropriate): RootID and version number (both SPL
metadata); effective date (to identify the reporting period); and the
number of units produced. Furthermore, if a product was not compounded
during a particular reporting period, no SPL response needs be sent for
that product during that reporting period.
    Finally, we expect to receive no more than one waiver request from
the electronic submission process for initial product reports and semi-
annual reports, and estimate each request will take 1 hour to prepare
and submit to FDA.
    Therefore, we estimate the burden of this collection of information
as follows:

                                 Table 1--Estimated Initial Reporting Burden \1\
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                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Submission of Initial Product                 55             220          12,100               2          24,200
 Report.........................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Initial Product
 Report.........................
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    Total.......................  ..............  ..............  ..............  ..............          24,201
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                   Number of
        Information collection activity            Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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Submission for June Product Report............              55             220          12,100  0.5 (30 minutes)........................           6,050
Submission for December Product Report........              55             220          12,100  0.5 (30 minutes)........................           6,050
Waiver Request From Electronic Submission of                 1               1               1  1.......................................               1
 Product Reports.
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    Total.....................................  ..............  ..............  ..............  ........................................          12,101
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    Dated: July 26, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-18048 Filed 7-29-16; 8:45 am]
 BILLING CODE 4164-01-P