Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Registering With the Center for Veterinary Medicine's Electronic Submission System, 55160-55161 [2019-22371]
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Notices
when determining priorities for
updating guidance documents and will
revise these as resources permit.
Consistent with the Good Guidance
Practices regulation at 21 CFR
10.115(f)(4), CDRH would appreciate
suggestions that CDRH revise or
withdraw an already existing guidance
document. We request that the
suggestion clearly explain why the
guidance document should be revised or
withdrawn and, if applicable, how it
should be revised. While we are
requesting feedback on the list of
previously issued final guidances
located in the annual agenda website,
feedback on any guidance is appreciated
and will be considered.
In FY 2019, CDRH received comments
regarding guidances issued in 2009,
1999, and 1989, and has withdrawn
three guidance documents in response
to comments received and because these
guidance documents were determined
to no longer represent the Agency’s
current thinking. The revision of several
guidance documents is also being
considered as resources permit.
III. Website Location of Guidance Lists
khammond on DSKJM1Z7X2PROD with NOTICES
This notice announces the website
location of the document that provides
the A and B lists of guidance
documents, which CDRH is intending to
publish during FY 2020. To access these
two lists, visit FDA’s website at https://
www.fda.gov/medical-devices/guidancedocuments-medical-devices-andradiation-emitting-products/cdrhproposed-guidance-development. We
note that the topics on this and past
guidance priority lists may be removed
or modified based on current priorities,
as well as comments received regarding
these lists. Furthermore, FDA and CDRH
priorities are subject to change at any
time (e.g., newly identified safety
issues). The Agency is not required to
publish every guidance on either list if
the resources needed would be to the
detriment of meeting quantitative
review timelines and statutory
obligations. In addition, the Agency is
not precluded from issuing guidance
documents that are not on either list.
Dated: October 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22370 Filed 10–11–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4839]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Registering With the
Center for Veterinary Medicine’s
Electronic Submission System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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
14, 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 0910–0454. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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:
Guidance for Industry on Registering
With the Center for Veterinary
Medicine’s Electronic Submission
System—21 CFR 11.2
OMB Control Number 0910–0454—
Extension
FDA’s ‘‘Electronic Records; Electronic
Signatures’’ regulation (21 CFR part 11)
requires that we identify in the
Electronic Submission Docket (Docket
No. FDA–1992–S–0039) the types of
documents or parts of documents
acceptable for official electronic
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submission. FDA’s Center for Veterinary
Medicine (CVM) has placed
notifications in that docket identifying
documents acceptable for electronic
submission to the Center, as required by
21 CFR 11.2. CVM’s ability to receive
and process information submitted
electronically is limited by its current
information technology capabilities and
the requirements of FDA’s ‘‘Electronic
Records; Electronic Signatures’’
regulation.
The FDA Electronic Submissions
Gateway (ESG) is an Agency-wide
solution for accepting electronic
regulatory submissions. The FDA ESG
enables the secure submission of
premarket and postmarket regulatory
information for review. The FDA ESG is
the central transmission point for
sending information electronically to
FDA. Within that context, the FDA ESG
is a conduit along which submissions
travel to reach the proper FDA Center or
Office. The CVM’s Electronic
Submission System (ESS) is a Centerwide solution for accepting electronic
regulatory submissions. The CVM ESS
is used to accept electronic submissions
for animal and veterinary products.
Our Guidance for Industry (GFI) #108
entitled ‘‘Registering with the Center for
Veterinary Medicine’s Electronic
Submission System’’ outlines general
standards to be used for the submission
of any electronic information to CVM
using the FDA ESG, including how to
register with the CVM ESS using Form
FDA 3538, ‘‘Electronic Submission
System Participant Management.’’
Registering with the CVM ESS allows
respondents to send electronic
regulatory submissions to the Office of
New Animal Drug Evaluation, the Office
of Surveillance and Compliance’s
Division of Animal Feeds and Division
of Surveillance, and the Office of Minor
Use and Minor Species Animal Drug
Development.
Respondents use GFI #108 and Form
FDA 3538 to facilitate the electronic
submission of regulatory information.
We use the information collected with
Form FDA 3538 to register respondents
to use the CVM ESS.
Description of Respondents: The
respondents are submitters of regulatory
information to CVM.
In the Federal Register of April 16,
2019 (84 FR 15621), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Notices
55161
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
FDA form No.
11.2 ...................
Form FDA 3538 .............
1 There
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22371 Filed 10–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0086]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Potential Tobacco
Product Violations Reporting Form
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
193
1.3
Total
annual
responses
Average burden per
response
251
0.08 (5 minutes) .............
Total hours
20
are no capital costs or operating and maintenance costs associated with this collection of information.
In the 60-day notice published April
16, 2019, we based our estimate of 179
respondents per year on our experience
with the submission of electronic
information using the CVM ESS and the
number of electronic registration or
change requests received between
January 1, 2018, and November 30,
2018. We are now adjusting our estimate
to 193 respondents per year to better
reflect the data for the time period
January 1 to December 31, 2018. Using
these new figures, our estimated burden
for the information collection reflects an
overall increase from the previous OMB
approval of 17 hours and a
corresponding increase of 213
responses. We attribute this adjustment
to the reauthorizations of both the
Animal Drug User Fee Act and the
Animal Generic Drug User Fee Act,
which require sponsors to submit
information electronically to the CVM’s
Office of New Animal Drug Evaluation.
Because of this requirement, sponsors
are now registering to use the CVM ESS
in greater numbers than in previous
years.
AGENCY:
Number of
responses per
respondent
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16:25 Oct 11, 2019
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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 the Potential
Tobacco Product Violations Reporting
Form.
Submit either electronic or
written comments on the collection of
information by December 16, 2019.
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 December 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 16, 2019.
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.
DATES:
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’’).
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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–N–0086 for ‘‘Potential Tobacco
Product Violations Reporting Form.’’
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
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
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]]>Agencies
[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55160-55161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22371]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4839]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Registering With the Center for Veterinary Medicine's Electronic
Submission System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 14, 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 0910-0454.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Guidance for Industry on Registering With the Center for Veterinary
Medicine's Electronic Submission System--21 CFR 11.2
OMB Control Number 0910-0454--Extension
FDA's ``Electronic Records; Electronic Signatures'' regulation (21
CFR part 11) requires that we identify in the Electronic Submission
Docket (Docket No. FDA-1992-S-0039) the types of documents or parts of
documents acceptable for official electronic submission. FDA's Center
for Veterinary Medicine (CVM) has placed notifications in that docket
identifying documents acceptable for electronic submission to the
Center, as required by 21 CFR 11.2. CVM's ability to receive and
process information submitted electronically is limited by its current
information technology capabilities and the requirements of FDA's
``Electronic Records; Electronic Signatures'' regulation.
The FDA Electronic Submissions Gateway (ESG) is an Agency-wide
solution for accepting electronic regulatory submissions. The FDA ESG
enables the secure submission of premarket and postmarket regulatory
information for review. The FDA ESG is the central transmission point
for sending information electronically to FDA. Within that context, the
FDA ESG is a conduit along which submissions travel to reach the proper
FDA Center or Office. The CVM's Electronic Submission System (ESS) is a
Center-wide solution for accepting electronic regulatory submissions.
The CVM ESS is used to accept electronic submissions for animal and
veterinary products.
Our Guidance for Industry (GFI) #108 entitled ``Registering with
the Center for Veterinary Medicine's Electronic Submission System''
outlines general standards to be used for the submission of any
electronic information to CVM using the FDA ESG, including how to
register with the CVM ESS using Form FDA 3538, ``Electronic Submission
System Participant Management.'' Registering with the CVM ESS allows
respondents to send electronic regulatory submissions to the Office of
New Animal Drug Evaluation, the Office of Surveillance and Compliance's
Division of Animal Feeds and Division of Surveillance, and the Office
of Minor Use and Minor Species Animal Drug Development.
Respondents use GFI #108 and Form FDA 3538 to facilitate the
electronic submission of regulatory information. We use the information
collected with Form FDA 3538 to register respondents to use the CVM
ESS.
Description of Respondents: The respondents are submitters of
regulatory information to CVM.
In the Federal Register of April 16, 2019 (84 FR 15621), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 55161]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
11.2.................. Form FDA 3538.................. 193 1.3 251 0.08 (5 minutes)............... 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In the 60-day notice published April 16, 2019, we based our
estimate of 179 respondents per year on our experience with the
submission of electronic information using the CVM ESS and the number
of electronic registration or change requests received between January
1, 2018, and November 30, 2018. We are now adjusting our estimate to
193 respondents per year to better reflect the data for the time period
January 1 to December 31, 2018. Using these new figures, our estimated
burden for the information collection reflects an overall increase from
the previous OMB approval of 17 hours and a corresponding increase of
213 responses. We attribute this adjustment to the reauthorizations of
both the Animal Drug User Fee Act and the Animal Generic Drug User Fee
Act, which require sponsors to submit information electronically to the
CVM's Office of New Animal Drug Evaluation. Because of this
requirement, sponsors are now registering to use the CVM ESS in greater
numbers than in previous years.
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22371 Filed 10-11-19; 8:45 am]
BILLING CODE 4164-01-P
