Product-Specific Guidance for Cilastatin Sodium; Imipenem; Relebactam; Draft Guidance for Industry; Availability, 38102-38103 [2021-15170]
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38102
Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices
American Academy of Pediatrics (AAP)
with support from CDC. The curriculum
uses a Train-the-Trainer model whereby
attending physicians at developmental
continuity clinics receive in-depth
training and then facilitate training of
first-year pediatric residents in their
own clinics.
In Phase One, training for attending
physicians will be organized around
four presentations by experts in the
identification, diagnosis, and care of
children with FASD and their families.
Pre/post-test assessments will be
obtained for each presentation, followed
by an overall assessment at the end of
the training day.
In Phase Two, the attending
physicians will implement a curriculum
of continuing medical education
activities with their first-year pediatric
residents. Required activities for
residents include viewing three prerecorded video presentations. Changes
in residents’ knowledge of training
content will be assessed both before and
after the video presentations.
Pre/post-test data will be collected
through paper-and-pencil surveys for inperson training of attending physicians,
and by secure email for resident
trainees. Attending physicians will also
be asked to participate in a final project
debriefing conference call.
The purpose and use of the
assessment data will be to assure that
specific information in the FASD
training curriculum is conveyed and
understood by participants. The public
health goal is to strengthen the
identification, referral, and care of
children with prenatal exposure to
alcohol.
OMB approval is requested for three
years. Approximately 10 clinics will be
recruited each year. Respondents will be
one attending physician per clinic, and
approximately 25 pediatric residents per
clinic. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annualized burden is 223 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Pediatrician (Attending Physician) ...
Attending Physicians Screening & Diagnosis Pretest ..
Attending Physicians Screening & Diagnosis Posttest
Attending Physicians Treatment Across Lifespan Pretest.
Attending Physicians Treatment Across Lifespan
Posttest.
Attending Physicians Overcoming Social Attitudes
Pretest.
Attending Physicians Overcoming Social Attitudes
Posttest.
Attending Physicians Educational Care Pretest ...........
Attending Physicians Educational Care Posttest .........
Attending Physicians Training Program Assessment ...
Attending Physicians Overall Program Assessment ....
Attending Physicians Debriefing Guide ........................
Attending Physicians Application (A15) ........................
Resident Overall Effects & Prevalence Video Pretest
Resident Overall Effects & Prevalence Video Posttest
Resident Overall Program Assessment ........................
Pediatrician (Resident) .....................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–15227 Filed 7–16–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Submit either electronic or
written comments on the draft guidance
by September 17, 2021 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
Product-Specific Guidance for
Cilastatin Sodium; Imipenem;
Relebactam; Draft Guidance for
Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
18:23 Jul 16, 2021
Jkt 253001
announcing the availability of a draft
guidance for industry entitled ‘‘Draft
Guidance for Cilastatin Sodium;
Imipenem; Relebactam.’’ The draft
guidance, when finalized, will provide
product-specific recommendations on,
among other things, the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for cilastatin sodium;
imipenem; relebactam for injection.
DATES:
[Docket No. FDA–2007–D–0369]
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Type of respondent
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00116
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Avg. burden
per response
(in hours)
10
10
10
1
1
1
10/60
10/60
10/60
10
1
10/60
10
1
10/60
10
1
10/60
10
10
10
10
10
10
250
250
250
1
1
1
1
1
1
1
1
1
10/60
10/60
15/60
20/60
1
10/60
15/60
15/60
15/60
• 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
E:\FR\FM\19JYN1.SGM
19JYN1
Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
lotter on DSK11XQN23PROD with NOTICES1
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–
2007–D–0369 for ‘‘Draft Guidance for
Cilastatin Sodium; Imipenem;
Relebactam.’’ 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-201509-18/pdf/2015-23389.pdf.
VerDate Sep<11>2014
18:23 Jul 16, 2021
Jkt 253001
38103
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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,
4th Floor, Silver Spring, MD 20993–
0002. 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.
FOR FURTHER INFORMATION CONTACT:
Christine Le, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4714, Silver Spring,
MD 20993–0002, 301–796–2398 and/or
PSG-QUESTIONS@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on, among other things, the design of BE
studies to support ANDAs for cilastatin
sodium; imipenem; relebactam for
injection. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs.
As described in that guidance, FDA
adopted this process to develop and
disseminate product-specific guidances
and to provide a meaningful
opportunity for the public to consider
and comment on the guidances. This
notice announces the availability of a
draft guidance on a generic Cilastatin
Sodium; Imipenem; Relebactam for
injection.
FDA initially approved new drug
application 212819 RECARBRIO
(cilastatin sodium; imipenem;
relebactam for injection) in July 2019.
We are now issuing a draft guidance for
industry on generic cilastatin sodium;
imipenem; relebactam for injection
(‘‘Draft Guidance on Cilastatin Sodium;
Imipenem; Relebactam’’).
This draft guidance is being issued
consistent with FDA’s good guidance
[FR Doc. 2021–15170 Filed 7–16–21; 8:45 am]
PO 00000
Frm 00117
Fmt 4703
Sfmt 4703
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: July 12, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
SUMMARY:
E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 38102-38103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidance for Cilastatin Sodium; Imipenem;
Relebactam; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Draft
Guidance for Cilastatin Sodium; Imipenem; Relebactam.'' The draft
guidance, when finalized, will provide product-specific recommendations
on, among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs) for cilastatin
sodium; imipenem; relebactam for injection.
DATES: Submit either electronic or written comments on the draft
guidance by September 17, 2021 to ensure that the Agency considers your
comment 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
[[Page 38103]]
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-2007-D-0369 for ``Draft Guidance for Cilastatin Sodium; Imipenem;
Relebactam.'' 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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, 4th Floor, Silver Spring, MD 20993-0002. 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.
FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398 and/or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a draft guidance on a generic
Cilastatin Sodium; Imipenem; Relebactam for injection.
FDA initially approved new drug application 212819 RECARBRIO
(cilastatin sodium; imipenem; relebactam for injection) in July 2019.
We are now issuing a draft guidance for industry on generic cilastatin
sodium; imipenem; relebactam for injection (``Draft Guidance on
Cilastatin Sodium; Imipenem; Relebactam'').
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 current thinking of FDA on, among other
things, the design of BE studies to support ANDAs for cilastatin
sodium; imipenem; relebactam for injection. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: July 12, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15170 Filed 7-16-21; 8:45 am]
BILLING CODE 4164-01-P
