Document ID: FDA-2014-D-2138-0001
Agency: fda
Document Type: Notice
Title: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Posted Date: 2015-02-19T05:00Z

[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8872-8874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03419]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Adverse Event Reporting for Outsourcing Facilities Under Section 
503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for 
Industry; 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announcing the availability of a draft guidance for industry entitled 
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B 
of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must 
submit adverse event reports to FDA. This guidance explains FDA's 
current thinking on adverse event reporting for 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draft guidance before it begins work to finalize the guidance, submit 
either electronic or written comments on this draft guidance by May 20, 
2015. Submit either electronic or written comments concerning the 
collection of information proposed in the draft guidance by May 20, 
2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10001 New 
Hampshire Ave., Hillandale Building,

[[Page 8873]]

4th Floor, Silver Spring, MD 20993. 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: H. Joy Sharp, Office of Compliance, 
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 ``Adverse Event Reporting for Outsourcing Facilities Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' On November 
27, 2013, President Obama signed the Drug Quality and Security Act 
(DQSA) into law (Pub. L. 113-54). The DQSA added a new section 503B to 
the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder can 
register as an outsourcing facility with FDA. Section 503B(d)(4) of the 
FD&C Act defines an outsourcing facility, in part, as a facility that 
complies with all of the requirements of section 503B, including 
registering with FDA as an outsourcing facility and paying associated 
fees. 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), an outsourcing facility must submit 
adverse event reports to FDA in accordance with the content and format 
requirements established through guidance or regulation under section 
310.305 of title 21, Code of Federal Regulations (or any successor 
regulations). This draft guidance explains how FDA intends to implement 
Sec.  310.305 with respect to outsourcing facilities.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on this topic. 
It 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.

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) 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 must 
submit to FDA adverse event reports within 15 calendar days of 
receiving the information and must submit a followup report 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 using the existing Form FDA 3500A (which is approved by 
OMB control number 0910-0291) or an alternate method in accordance with 
Sec.  310.305(d). A copy of the current labeling of the compounded drug 
product must be included. Each form should be submitted with a cover 
letter that includes the following heading: ``Adverse event report 
submitted by human drug compounding outsourcing facility (503B).''
    Under Sec.  310.305, entities subject to the regulation must 
maintain for 10 years the records of all adverse events required to be 
reported under Sec.  310.305, including raw data and any correspondence 
relating to the adverse event. 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.
    The total estimated reporting and recordkeeping burdens for the 
draft guidance are as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
        Type of reporting            Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
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Submission of adverse event                   50               2             100             1.1             110
 reports including cover letter,
 copy of labeling, and other
 information as described in the
 draft guidance.................
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    Total.......................  ..............  ..............  ..............  ..............             110
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 8874]]

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                                                         Average burden
                                                                        Number of        Number of       Total annual         per
                       Type of recordkeeping                          recordkeepers     records per        records       recordkeeping     Total hours
                                                                                        recordkeeper                        (hours)
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Records of adverse events, including records of efforts to obtain                50                1               50               16              800
 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.

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 
can 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.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03419 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P