Document ID: FDA-2014-D-2138-0017
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2018-06-21T04:00Z

[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28854-28856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13294]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2014-D-2138]

Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on adverse event reporting for outsourcing facilities 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by August 20, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 20, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA 2014-D-2138 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry: Adverse 
Event Reporting for Outsourcing Facilities Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential

[[Page 28855]]

with a heading or cover note that states ``THIS DOCUMENT CONTAINS 
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including 
the claimed confidential information, in its consideration of comments. 
The second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted 
on https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. If you do not wish your name and contact information 
to be made publicly available, you can provide this information on the 
cover sheet and not in the body of your comments and you must identify 
this information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under 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 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 concerning each proposed collection of information, including 
each proposed extension of an existing 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 following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (DQSA) (Pub. L. 113-54), which amended 
the FD&C Act by adding new section 503B (21 U.S.C. 353b).
    This notice solicits comments on adverse event reporting for 
outsourcing facilities under section 503B of the FD&C Act.
    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 (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 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''.\1\ The guidance explains electronic reporting of 
adverse events in accordance with Sec.  310.305 with respect to 
outsourcing facilities.
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    \1\ Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.
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    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(g), 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.
    We estimate the burden of the information collection as follows:

[[Page 28856]]

                                                      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: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13294 Filed 6-20-18; 8:45 am]
BILLING CODE 4164-01-P