Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements, 5784-5785 [2018-02589]
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5784
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
10.75, Request for review of a scientific dispute ................
1
4
4
10
40
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the next 3 years, CVM anticipates
receiving one or fewer requests for
review of a scientific dispute per year,
on average. We base our estimate on
CVM’s experience over the past 6 years
in handling formal appeals for scientific
disputes. The burden of this collection
has changed. The number of
respondents decreased from two to one
annually, the number of responses per
respondent remained at four annually,
the hours per response remained at 10
annually, and the total number of hours
decreased from 80 to 40. This decrease
in the total hours is the result of a
natural fluctuation in the number of
respondents taking advantage of this
dispute resolution process.
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02593 Filed 2–8–18; 8:45 am]
BILLING CODE 4164–01–P
Fax written comments on the
collection of information by March 12,
2018.
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 0910–0770. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0334]
Postmarketing Safety Reports for
Human Drug and Biological Products:
Waivers From Electronic Submission
Requirements
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Safety Reports for Human Drug and
Biological Products: Electronic
Submission Requirements
OMB Control Number 0910–0770—
Extension
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.
This information collection supports
information collection found in FDA
regulations. In the Federal Register of
June 10, 2014 (79 FR 33072), FDA
published a final rule entitled
‘‘Postmarketing Safety Reports for
Human Drug and Biological Products:
Electronic Submission Requirements.’’
The final rule amended FDA’s
postmarketing safety reporting
regulations for human drug and
biological products under 21 CFR parts
310, 314, and 600 and added part 329
1 FDA currently has OMB approval for
submission of postmarketing safety reports under
parts 310, 314, and 600. The information collection
for parts 310 and 314 is approved under OMB
Control Numbers 0910–0291 and 0910–0230. The
information collection for part 600 is approved
under OMB Control Numbers 0910–0291 and 0910–
0308. Submissions required by section 760 of the
AGENCY:
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
Notice.
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16:57 Feb 08, 2018
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to require that persons subject to
mandatory reporting requirements
submit safety reports in an electronic
format that FDA can process, review,
and archive. Specifically, this includes:
• Manufacturers; packers;
distributors; applicants with approved
new drug applications, abbreviated new
drug applications, and biologics
licensing applications (BLAs); and those
that market prescription drugs for
human use without an approved
application must submit postmarketing
safety reports to the Agency (§§ 310.305,
314.80, 314.98, and 600.80);
• manufacturers, packers, or
distributors whose name appears on the
label of nonprescription human drug
products marketed without an approved
application must report serious adverse
events associated with their products
(section 760 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
379aa)); and
• applicants with approved BLAs
must submit biological lot distribution
reports to the Agency (§ 600.81).
Under §§ 310.305(e)(2), 314.80(g)(2),
329.100(c)(2), 600.80(h)(2), and
600.81(b)(2), of the regulations, those
who are subject to these postmarketing
safety reporting requirements may
request a waiver from the electronic
format requirement. While FDA
currently has OMB approval for the
collection of postmarketing safety
reports,1 this information collection
supports respondents seeking waivers
from submitting those reports in
electronic format as required by the
regulations.
In the Federal Register of October 30,
2017 (82 FR 50141), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received in response to the notice.
We therefore estimate the burden of
this collection of information as follows:
FD&C Act have been approved under OMB Control
Number 0910–0636.
E:\FR\FM\09FEN1.SGM
09FEN1
5785
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total
hours
310.305(e)(2) .......................................................................
314.80(g)(2) .........................................................................
329.100(c)(2) ........................................................................
600.80(h)(2) .........................................................................
600.81(b)(2) .........................................................................
1
5
1
5
1
1
1
1
1
1
1
5
1
5
1
1
1
1
1
1
1
5
1
5
1
Total ..............................................................................
........................
........................
........................
........................
13
1 There
are no capital or operating and maintenance costs associated with this collection of information.
In table 1, we estimate the burden
associated with the submission of
waiver requests for postmarketing safety
reports in electronic format under
§§ 310.305(e)(2), 314.80(g)(2),
329.100(c)(2), 600.80(h)(2), and
600.81(b)(2). We expect few waiver
requests. We estimate only one
manufacturer will request a waiver
annually under §§ 310.305(e)(2),
329.100(c)(2), and 600.81(b)(2), and
approximately five manufacturers will
request waivers annually under
§§ 314.80(g)(2) and 600.80(h)(2). We
estimate that each waiver request takes
1 hour to prepare and submit. The
burden for this information collection
has not increased since the last
collection.
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02589 Filed 2–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of
additional draft and revised draft
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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16:57 Feb 08, 2018
Jkt 244001
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website. The guidances
identified in this notice were developed
using the process described in that
guidance.
Submit either electronic or
written comments on the draft guidance
by April 10, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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:
PO 00000
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• 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 ‘‘Product-Specific
Guidances; Draft and Revised Draft
Guidances for Industry.’’ 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.
• 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
E:\FR\FM\09FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5784-5785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0334]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Safety
Reports for Human Drug and Biological Products: Electronic Submission
Requirements
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 March
12, 2018.
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 0910-0770.
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.
Postmarketing Safety Reports for Human Drug and Biological Products:
Waivers From Electronic Submission Requirements
OMB Control Number 0910-0770--Extension
This information collection supports information collection found
in FDA regulations. In the Federal Register of June 10, 2014 (79 FR
33072), FDA published a final rule entitled ``Postmarketing Safety
Reports for Human Drug and Biological Products: Electronic Submission
Requirements.'' The final rule amended FDA's postmarketing safety
reporting regulations for human drug and biological products under 21
CFR parts 310, 314, and 600 and added part 329 to require that persons
subject to mandatory reporting requirements submit safety reports in an
electronic format that FDA can process, review, and archive.
Specifically, this includes:
Manufacturers; packers; distributors; applicants with
approved new drug applications, abbreviated new drug applications, and
biologics licensing applications (BLAs); and those that market
prescription drugs for human use without an approved application must
submit postmarketing safety reports to the Agency (Sec. Sec. 310.305,
314.80, 314.98, and 600.80);
manufacturers, packers, or distributors whose name appears
on the label of nonprescription human drug products marketed without an
approved application must report serious adverse events associated with
their products (section 760 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379aa)); and
applicants with approved BLAs must submit biological lot
distribution reports to the Agency (Sec. 600.81).
Under Sec. Sec. 310.305(e)(2), 314.80(g)(2), 329.100(c)(2),
600.80(h)(2), and 600.81(b)(2), of the regulations, those who are
subject to these postmarketing safety reporting requirements may
request a waiver from the electronic format requirement. While FDA
currently has OMB approval for the collection of postmarketing safety
reports,\1\ this information collection supports respondents seeking
waivers from submitting those reports in electronic format as required
by the regulations.
---------------------------------------------------------------------------
\1\ FDA currently has OMB approval for submission of
postmarketing safety reports under parts 310, 314, and 600. The
information collection for parts 310 and 314 is approved under OMB
Control Numbers 0910-0291 and 0910-0230. The information collection
for part 600 is approved under OMB Control Numbers 0910-0291 and
0910-0308. Submissions required by section 760 of the FD&C Act have
been approved under OMB Control Number 0910-0636.
---------------------------------------------------------------------------
In the Federal Register of October 30, 2017 (82 FR 50141), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
We therefore estimate the burden of this collection of information
as follows:
[[Page 5785]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
310.305(e)(2)................... 1 1 1 1 1
314.80(g)(2).................... 5 1 5 1 5
329.100(c)(2)................... 1 1 1 1 1
600.80(h)(2).................... 5 1 5 1 5
600.81(b)(2).................... 1 1 1 1 1
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 13
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
In table 1, we estimate the burden associated with the submission
of waiver requests for postmarketing safety reports in electronic
format under Sec. Sec. 310.305(e)(2), 314.80(g)(2), 329.100(c)(2),
600.80(h)(2), and 600.81(b)(2). We expect few waiver requests. We
estimate only one manufacturer will request a waiver annually under
Sec. Sec. 310.305(e)(2), 329.100(c)(2), and 600.81(b)(2), and
approximately five manufacturers will request waivers annually under
Sec. Sec. 314.80(g)(2) and 600.80(h)(2). We estimate that each waiver
request takes 1 hour to prepare and submit. The burden for this
information collection has not increased since the last collection.
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02589 Filed 2-8-18; 8:45 am]
BILLING CODE 4164-01-P
