Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Extension of Comment Period, 35936-35937 [2020-12750]
Download as PDF
<(1) and Sec. 811 [42 U.S.C. 2992].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–12739 Filed 6–11–20; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4533]
Compounding Animal Drugs From
Bulk Drug Substances; Draft Guidance
for Industry; Availability; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability that published in
the Federal Register on November 20,
2019. In that notice, FDA requested
comments on the draft guidance for
industry (GFI) #256 entitled
‘‘Compounding Animal Drugs from Bulk
Drug Substances.’’ FDA is taking this
action in response to requests for an
extension to allow interested persons
additional time to submit comments.
DATES: FDA is further extending the
comment period on the document
published November 20, 2019 (84 FR
64085), which was reopened in a
document published February 20, 2020
(85 FR 9783). Submit either electronic
or written comments on the draft
guidance by October 15, 2020, to ensure
that the Agency considers your
comments on this draft guidance before
it begins work on the final version of the
guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
17:43 Jun 11, 2020
Jkt 250001
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–
2018–D–4533 for ‘‘Compounding
Animal Drugs From Bulk Drug
Substances.’’ Received comments 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, 240–402–7500.
• 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
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
Eric
Nelson, Division of Compliance (HFV–
230), Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
402–7001, cvmcompliance@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of November 20, 2019,
FDA published a notice announcing the
availability of draft GFI #256 entitled
‘‘Compounding Animal Drugs From
Bulk Drug Substances’’ with a 90-day
comment period. We requested
comments on the draft guidance with
respect to animal drug compounding
from bulk drug substances under certain
circumstances when no other medically
appropriate treatment option exists.
Interested persons were originally
given until February 18, 2020, to
comment on the draft guidance. The
Agency received requests to allow
interested persons additional time to
comment. The requests conveyed
concern that the initial 90-day comment
period did not allow sufficient time to
develop a comprehensive response.
FDA considered these requests and
reopened the comment period for an
additional 120 days, until June 17, 2020
(85 FR 9783).
Since then, FDA has received
additional requests to further extend the
comment period. FDA has considered
the requests and is extending the
comment period for the notice of
availability for another 120 days, until
October 15, 2020. The Agency believes
that a further extension of 120 days
allows adequate time for interested
persons to submit comments.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12JNN1.SGM
12JNN1
35937
Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
Dated: June 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12750 Filed 6–11–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0144]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary Qualified
Importer Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: Submit written comments
(including recommendations) on the
collection of information by July 13,
2020.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0840. Also include
the FDA docket number found in
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
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.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA’s Voluntary
Qualified Importer Program
OMB Control Number 0910–0840—
Extension
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
helping to ensure the safety and security
of the food supply. It enables FDA to
focus more on preventing food safety
problems rather than relying primarily
on reacting to problems after they occur.
FSMA recognizes the important role
industry plays in ensuring the safety of
the food supply, including the adoption
of modern systems of preventive
controls in food production. Under
FSMA, those that import food have a
responsibility to ensure that their
suppliers produce food that meets U.S.
safety standards.
FSMA also requires FDA to establish
a voluntary, fee-based program for the
expedited review and importation of
foods by importers who achieve and
maintain a high level of control over the
safety and security of their supply
chains. This control includes
importation of food from facilities that
have been certified under FDA’s
accredited third-party certification
program, as well as other measures that
support a high level of confidence in the
safety and security of the food they
import. Expedited entry incentivizes
importers to adopt a robust system of
supply chain management and further
benefits public health by allowing FDA
to focus its resources on food entries
that pose a higher risk to public health.
Section 302 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding new section 806,
Voluntary Qualified Importer Program
(VQIP) (21 U.S.C. 384b). Section
806(a)(1) of the FD&C Act directs FDA
to establish this voluntary program for
the expedited review and importation of
food, and to establish a process for the
issuance of a facility certification to
accompany food offered for importation
by importers participating in VQIP.
Section 806(a)(2) directs FDA to issue a
guidance document related to
participation in, revocation of such
participation in, reinstatement in, and
compliance with VQIP. Accordingly, in
the Federal Register of November 14,
2016 (81 FR 79502), FDA published a
notice announcing the availability of a
final guidance for industry entitled
‘‘FDA’s Voluntary Qualified Importer
Program.’’ The guidance is available
from our website at: https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-fdas-voluntaryqualified-importer-program.
In the Federal Register of February 5,
2020 (85 FR 6556) we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received. We estimate the burden of the
information collection as follows:
TABLE 1—ONE-TIME RECORDKEEPING BURDEN 1
Number of
respondents
Information collection activity
Quality Assurance Program (QAP) preparation ..................
jbell on DSKJLSW7X2PROD with NOTICES
1 There
Number of
responses per
respondent
200
Total annual
responses
1
200
Average
burden per
response
160
Total hours
32,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our one-time
recordkeeping burden estimate. On
average, the preparation of a QAP by a
VQIP applicant is estimated at
approximately 160 hours (110 + 40 +
10). In estimation of the one-time
recordkeeping burden to prepare a QAP
manual, we assume that VQIP importers
VerDate Sep<11>2014
17:43 Jun 11, 2020
Jkt 250001
do not already have a similar manual in
place (e.g., food safety plan under the
Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based
Preventive Controls for Human Food
regulation (21 CFR part 117); food
defense plan under the Focused
Mitigation Strategies to Protect Food
Against Intentional Adulteration
regulation (IA regulation) (21 CFR part
121)). We continue to use the
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
recordkeeping burden of preparing a
food safety plan under part 117, 110
hours, as a proxy for the burden to
prepare QAP Food Safety Policies and
Procedures. We continue to estimate
that, on average, it would take 40 hours
for an applicant to prepare the food
defense portion of the VQIP QAP,
similar to the estimated burden for
preparing a food defense plan under the
IA regulation. We also continue to
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35936-35937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12750]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4533]
Compounding Animal Drugs From Bulk Drug Substances; Draft
Guidance for Industry; Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
published in the Federal Register on November 20, 2019. In that notice,
FDA requested comments on the draft guidance for industry (GFI) #256
entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is
taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.
DATES: FDA is further extending the comment period on the document
published November 20, 2019 (84 FR 64085), which was reopened in a
document published February 20, 2020 (85 FR 9783). Submit either
electronic or written comments on the draft guidance by October 15,
2020, to ensure that the Agency considers your comments on this draft
guidance before it begins work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2018-D-4533 for ``Compounding Animal Drugs From Bulk Drug
Substances.'' Received comments 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, 240-402-7500.
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 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.govinfo.gov/content/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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Eric Nelson, Division of Compliance
(HFV-230), Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7001,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of November 20,
2019, FDA published a notice announcing the availability of draft GFI
#256 entitled ``Compounding Animal Drugs From Bulk Drug Substances''
with a 90-day comment period. We requested comments on the draft
guidance with respect to animal drug compounding from bulk drug
substances under certain circumstances when no other medically
appropriate treatment option exists.
Interested persons were originally given until February 18, 2020,
to comment on the draft guidance. The Agency received requests to allow
interested persons additional time to comment. The requests conveyed
concern that the initial 90-day comment period did not allow sufficient
time to develop a comprehensive response. FDA considered these requests
and reopened the comment period for an additional 120 days, until June
17, 2020 (85 FR 9783).
Since then, FDA has received additional requests to further extend
the comment period. FDA has considered the requests and is extending
the comment period for the notice of availability for another 120 days,
until October 15, 2020. The Agency believes that a further extension of
120 days allows adequate time for interested persons to submit
comments.
[[Page 35937]]
Dated: June 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12750 Filed 6-11-20; 8:45 am]
BILLING CODE 4164-01-P
