Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 54612-54613 [2019-22189]
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Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices
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Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22187 Filed 10–9–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–1428]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
Food and Drug Administration,
VerDate Sep<11>2014
20:53 Oct 09, 2019
Jkt 250001
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 November
12, 2019.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0827. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
OMB Control Number 0910–0827—
Extension
Food and Drug Administration
HHS.
Notice.
Electronic Drug Product Reporting for
Human Drug Compounding
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act
BILLING CODE 4164–01–P
AGENCY:
ACTION:
The Drug Quality and Security Act
added section 503B to the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353b) creating a category of
entities called ‘‘outsourcing facilities.’’
Outsourcing facilities, as defined in
section 503B(d)(4) of the FD&C Act, are
facilities that must meet all the
requirements described in section 503B,
including registering with FDA as an
outsourcing facility and submitting
regular reports identifying the drugs
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
compounded by the outsourcing facility
during the previous 6-month period.
The first of these reports must be
submitted upon initial registration as an
outsourcing facility. Thereafter,
semiannual product reports must be
submitted, once during the month of
June and once during the month of
December, for as long as an
establishment remains registered as an
outsourcing facility.
In addition, drug products
compounded in an outsourcing facility
can qualify for exemptions from the
FDA approval requirements in section
505 of the FD&C Act (21 U.S.C. 355) and
the requirement to label products with
adequate directions for use under
section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)) if the requirements in
section 503B are met.
To help respondents understand the
statutory requirements, how we
interpret them, and the associated
information collection, we developed
the guidance document entitled
‘‘Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
The guidance is available from our
website at: https://www.fda.gov/media/
90173/download. The guidance
explains that, once an entity has elected
to register as an outsourcing facility, it
must submit reports identifying the
drugs compounded by the outsourcing
facility. The guidance also
communicates who must report, the
format of the report, the content to
include in each report, when to report,
how reports are submitted to FDA, and
the consequences of outsourcing
facilities’ failure to submit reports.
In the Federal Register of July 17,
2019 (84 FR 34184), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We therefore estimate the burden of
the information collection as follows:
E:\FR\FM\10OCN1.SGM
10OCN1
54613
Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Product reporting for compounding outsourcing facilities
Average
burden per
response
Total annual
responses
Total hours
Initial product reports ...........................................................
Waiver request from electronic submission of initial product reports ........................................................................
June product reports ............................................................
December product reports ...................................................
Waiver request from electronic submission of product reports ..................................................................................
75
1.01
76
2
152
1
75
75
1
1.01
1.01
1
76
76
1
0.5
0.5
1
38
38
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
230
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on current data for outsourcing
facilities, we estimate that 75
outsourcing facilities will submit an
initial report identifying all drugs
compounded in the facility in the
previous 6 months. For the purposes of
this estimate, each product’s structured
product labeling (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
each facility will average 76 products.
Our estimate is based on current
product reporting data.
We expect each product report will
consist of multiple SPL responses per
facility and estimate that preparing and
submitting this information
electronically may take up to 2 hours for
each initial SPL response. We also
estimate that the 75 registered
outsourcing facilities will submit a
report twice each year identifying all
drugs compounded at the facility in the
previous 6 months.
As stated above, we estimate on
average 76 SPL responses per facility
and that preparing and submitting this
information electronically will take
approximately 30 minutes per response.
We have reduced our burden estimate
for semiannual product submissions
because 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 the RootID
and version number (both SPL
metadata), effective date (to identify the
reporting period), and the number of
units produced, along with other data as
appropriate, to appropriate values for
the reporting period. 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.
VerDate Sep<11>2014
19:50 Oct 09, 2019
Jkt 250001
We expect to receive no more than
one waiver request, each, from the
electronic submission process for initial
product reports and semiannual reports,
and that each waiver request will take
1 hour to prepare and submit.
Based on submissions we have
received, we have reduced the number
of responses significantly since our
original estimate establishing the
collection. This results in an overall
reduction to the information collection
by 36,072 hours.
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22189 Filed 10–9–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0944]
Electronic Submissions
Investigational In Vitro Diagnostics in
Oncology Trials: Streamlined
Submission Process for Study Risk
Determination; Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Investigational In Vitro Diagnostics in
Oncology Trials: Streamlined
Submission Process for Study Risk
Determination.’’ This guidance,
developed by the Oncology Center of
Excellence at FDA, describes an
optional streamlined submission
process to determine whether use of an
investigational in vitro diagnostic in an
oncology clinical trial is considered
significant risk, nonsignificant risk, or
exempt from investigational device
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
The announcement of the
guidance is published in the Federal
Register on October 10, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
BILLING CODE 4164–01–P
AGENCY:
exemption requirements. In the
streamlined process, the sponsor
submits all information about the
oncology trial (including information
about the investigational in vitro
diagnostic) to the investigational new
drug application (IND). As part of IND
review, the Center for Biologics
Evaluation and Research (CBER) works
with the Center for Drug Evaluation and
Research (CDER), or CDER or CBER
works with the Center for Devices and
Radiological Health (CDRH), as
appropriate, to determine if the
investigational in vitro diagnostic is
significant risk, nonsignificant risk, or
exempt.
Sfmt 4703
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
E:\FR\FM\10OCN1.SGM
10OCN1
]]>Agencies
[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54612-54613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22189]
-----------------------------------------------------------------------
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; Electronic Drug
Product Reporting for Human Drug Compounding Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
November 12, 2019.
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 0910-0827.
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 has
submitted the following proposed collection of information to OMB for
review and clearance.
Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act
OMB Control Number 0910-0827--Extension
The Drug Quality and Security Act added section 503B to the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) creating a
category of entities called ``outsourcing facilities.'' Outsourcing
facilities, as defined in section 503B(d)(4) of the FD&C Act, are
facilities that must meet all the requirements described in section
503B, including registering with FDA as an outsourcing facility and
submitting regular reports identifying the drugs compounded by the
outsourcing facility during the previous 6-month period. The first of
these reports must be submitted upon initial registration as an
outsourcing facility. Thereafter, semiannual product reports must be
submitted, once during the month of June and once during the month of
December, for as long as an establishment remains registered as an
outsourcing facility.
In addition, drug products compounded in an outsourcing facility
can qualify for exemptions from the FDA approval requirements in
section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to
label products with adequate directions for use under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section
503B are met.
To help respondents understand the statutory requirements, how we
interpret them, and the associated information collection, we developed
the guidance document entitled ``Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.'' The guidance is available from
our website at: https://www.fda.gov/media/90173/download. The guidance
explains that, once an entity has elected to register as an outsourcing
facility, it must submit reports identifying the drugs compounded by
the outsourcing facility. The guidance also communicates who must
report, the format of the report, the content to include in each
report, when to report, how reports are submitted to FDA, and the
consequences of outsourcing facilities' failure to submit reports.
In the Federal Register of July 17, 2019 (84 FR 34184), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We therefore estimate the burden of the information collection as
follows:
[[Page 54613]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Product reporting for Number of
compounding outsourcing Number of responses per Total annual Average burden Total hours
facilities respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Initial product reports......... 75 1.01 76 2 152
Waiver request from electronic 1 1 1 1 1
submission of initial product
reports........................
June product reports............ 75 1.01 76 0.5 38
December product reports........ 75 1.01 76 0.5 38
Waiver request from electronic 1 1 1 1 1
submission of product reports..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 230
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on current data for outsourcing facilities, we estimate that
75 outsourcing facilities will submit an initial report identifying all
drugs compounded in the facility in the previous 6 months. For the
purposes of this estimate, each product's structured product labeling
(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 each facility will average
76 products. Our estimate is based on current product reporting data.
We expect each product report will consist of multiple SPL
responses per facility and estimate that preparing and submitting this
information electronically may take up to 2 hours for each initial SPL
response. We also estimate that the 75 registered outsourcing
facilities will submit a report twice each year identifying all drugs
compounded at the facility in the previous 6 months.
As stated above, we estimate on average 76 SPL responses per
facility and that preparing and submitting this information
electronically will take approximately 30 minutes per response. We have
reduced our burden estimate for semiannual product submissions because
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 the RootID and version
number (both SPL metadata), effective date (to identify the reporting
period), and the number of units produced, along with other data as
appropriate, to appropriate values for the reporting period.
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.
We expect to receive no more than one waiver request, each, from
the electronic submission process for initial product reports and
semiannual reports, and that each waiver request will take 1 hour to
prepare and submit.
Based on submissions we have received, we have reduced the number
of responses significantly since our original estimate establishing the
collection. This results in an overall reduction to the information
collection by 36,072 hours.
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22189 Filed 10-9-19; 8:45 am]
BILLING CODE 4164-01-P
