83 FR 28854 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 120 (June 21, 2018)

Page Range		28854-28856
FR Document		2018-13294

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).

Federal Register, Volume 83 Issue 120 (Thursday, June 21, 2018)

[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28854-28856]
From the Federal Register Online [www.thefederalregister.org]
[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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of adverse event reports including copy of labeling and 55 1 55 1.1 61
other information as described in the guidance....................
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of recordkeeping Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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

28856 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Compounding outsourcing facility responses per burden per Total hours
respondents responses
respondent response

Submission of adverse event reports including copy of la-
beling and other information as described in the guid-
ance .................................................................................. 55 1 55 1.1 61
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Type of recordkeeping records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

Records of adverse events, including records of efforts to
obtain the data elements for each adverse event report 55 1 55 16 880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

This is the first extension of the Dated: June 14, 2018. longer marketed and requested that the
information collection and we have Leslie Kux, approval of the applications be
retained the currently approved burden Associate Commissioner for Policy. withdrawn.
estimate. Based on our review of Agency [FR Doc. 2018–13294 Filed 6–20–18; 8:45 am]
DATES: Approval is withdrawn as of July
data, we estimate that annually 55 BILLING CODE 4164–01–P
23, 2018.
outsourcing facilities (‘‘Number of
Respondents’’ and ‘‘Total Annual FOR FURTHER INFORMATION CONTACT:
Responses’’ in table 1) will submit DEPARTMENT OF HEALTH AND Florine P. Purdie, Center for Drug
adverse event reports to FDA as HUMAN SERVICES Evaluation and Research, Food and
Drug Administration, 10903 New
specified in the guidance and that
Food and Drug Administration Hampshire Ave., Bldg. 51, Rm. 6248,
preparing and submitting this
[Docket No. FDA–2018–N–2194] Silver Spring, MD 20993–0002, 301–
information will take approximately 1.1
796–3601.
hours per registrant (‘‘Average Burden
Novartis Pharmaceuticals Corporation, SUPPLEMENTARY INFORMATION: The
per Response’’ in table 1). Likewise, we
et al.; Withdrawal of Approval of Five holders of the applications listed in the
estimate that annually 55 outsourcing
New Drug Applications table have informed FDA that these drug
facilities (‘‘Number of Recordkeepers’’
in table 2) will maintain records of AGENCY: Food and Drug Administration, products are no longer marketed and
adverse events as specified in the HHS. have requested that FDA withdraw
ACTION: Notice. approval of the applications under the
guidance and that preparing and
process in § 314.150(c) (21 CFR
maintaining the records will take
SUMMARY: The Food and Drug 314.150(c)). The applicants have also,
approximately 16 hours per registrant by their requests, waived their
Administration (FDA or Agency) is
(‘‘Average Burden per Recordkeeping’’ withdrawing approval of five new drug opportunity for a hearing. Withdrawal
in table 2). applications (NDAs) from multiple of approval of an application or
applicants. The holders of the abbreviated application under
applications notified the Agency in § 314.150(c) is without prejudice to
writing that the drug products were no refiling.

Application No. Drug Applicant

NDA 020831 ...... Foradil Aerolizer (formoterol fumarate) Powder, 0.012 milli- Novartis Pharmaceuticals Corp., One Health Pl., East Han-
gram (mg)/inhalation. over, NJ 07936.
NDA 022504 ...... Axiron (testosterone) Transdermal Metered Solution, 30 mg/ Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
1.5 milliliter (mL) actuation. 46285.
NDA 050585 ...... Rocephin (ceftriaxone sodium) for Injection, equivalent to Hoffmann-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way,
(EQ) 10 gram (g) base/vial, EQ 250 mg base/vial (IV/IM), South San Francisco, CA 94080.
EQ 500 mg base/vial (IV/IM), EQ 1 g base/vial (IV/IM), EQ
2 g base/vial (IV/IM), EQ 500 mg base/vial, N/A; N/A, 1%
(Rocephin kit), EQ 1 g base/vial, N/A; N/A, 1% (Rocephin
kit).
NDA 050624 ...... Rocephin (ceftriaxone sodium) with Dextrose in Plastic Con- Do.
amozie on DSK3GDR082PROD with NOTICES1

tainer Injection, EQ 10 mg base/mL, EQ 20 mg base/mL,
and EQ 40 mg base/mL.
NDA 202763 ...... Testosterone Gel, 25 mg/2.5 g packet, 50 mg/5 g packet ...... ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN
56623.

VerDate Sep<11>2014 17:22 Jun 20, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1

Document Created: 2018-06-21 01:23:21
Document Modified: 2018-06-21 01:23:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 20, 2018.
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]
FR Citation		83 FR 28854

83 FR 28854 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 120 (June 21, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration