[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48619-48620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Adverse Event Reporting for 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 October 
26, 2018.

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 OMB control number 0910-0800. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA

[[Page 48620]]

has submitted the following proposed collection of information to OMB 
for review and clearance.

Guidance for Industry: Adverse Event Reporting for Outsourcing 
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act

OMB Control Number 0910-0800--Extension

    This information collection supports Agency implementation of the 
Drug Quality and Security Act (Pub. L. 113-54), which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding new section 
503B (21 U.S.C. 353b). Under section 503B(b) of the FD&C Act, 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 (NDAs) or abbreviated new drug 
applications (ANDAs)). 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).
    Under section 503B(b)(5) of the FD&C Act, an outsourcing facility 
must submit adverse event reports to FDA in accordance with the content 
and format requirements established through guidance or regulation 
under Sec.  310.305 (21 CFR 310.305) (or any successor regulations). 
Accordingly, we developed the document, ``Guidance for Industry: 
Adverse Event Reporting for Outsourcing Facilities Under Section 503B 
of the Federal Food, Drug, and Cosmetic Act.'' For a copy of guidance 
documents, go to https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, insert the title of the guidance document in the 
``Search'' box and follow the prompts. The guidance explains electronic 
reporting of adverse events in accordance with Sec.  310.305 with 
respect to outsourcing facilities.
    Under Sec.  310.305(c)(1), manufacturers, packers, and distributors 
of marketed prescription drug products that are not the subject of an 
approved NDA or ANDA, including, as set forth in the guidance, 
outsourcing facilities must submit to FDA adverse event reports within 
15 calendar days of receiving the information and must submit follow-up 
reports within 15 calendar days of receipt of new information about the 
adverse event, or as requested by FDA. Outsourcing facilities must 
submit the adverse event report in an electronic format that FDA can 
process, review, and archive (collection of information is approved by 
OMB control number 0910-0291). A copy of the current labeling of the 
compounded drug product must be provided.
    Under Sec.  310.305(f), entities subject to the regulation must 
maintain for 10 years the records of all adverse events required to be 
reported under Sec.  310.305. The outsourcing facility should also 
maintain records of its efforts to obtain the data elements described 
in the draft guidance for each adverse event report.
    In the Federal Register of August 21, 2018 (83 FR 28854), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden for the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \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
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Submission of adverse event reports' including copy of labeling and              55                1               55              1.1               61
 other information as described in the guidance....................
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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 Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                       Type of recordkeeping                            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Records of adverse events, including records of efforts to obtain                55                1               55               16              880
 the data elements for each adverse event report...................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This is the first extension of the information collection and we 
have retained the currently approved burden estimate. Based on our 
review of Agency data, we estimate that annually 55 outsourcing 
facilities (``Number of Respondents'' and ``Total Annual Responses'' in 
table 1) will submit adverse event reports to FDA as specified in the 
guidance and that preparing and submitting this information will take 
approximately 1.1 hours per registrant (``Average Burden per Response'' 
in table 1). Likewise, we estimate that annually 55 outsourcing 
facilities (``Number of Recordkeepers'' in table 2) will maintain 
records of adverse events as specified in the guidance and that 
preparing and maintaining the records will take approximately 16 hours 
per registrant (``Average Burden per Recordkeeping'' in table 2).

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20909 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P