[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Notices]
[Pages 50523-50525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 202-395-7285, or emailed to [email protected]. 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 protected].

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).

[[Page 50524]]

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:

[[Page 50525]]



                                 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