Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Availability; Establishment of Public Docket; Request for Comments, 60094-60095 [2019-24332]
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60094
Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of Collection
Agreement for Shipment of Devices for Sterilization ..............................................................................................
Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed ..........
Clinical Laboratory Improvement Amendments Waiver Applications .....................................................................
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and
Listing of Ingredients in Tobacco Products .........................................................................................................
Tobacco Health Document Submission ..................................................................................................................
Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence Requirements for Tobacco Products ..................................................................................
Exemptions From Substantial Equivalence Requirements for Tobacco Products .................................................
Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity
New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts and
351(k) Biologics License Applications in Biosimilars User Fee Act ....................................................................
Medical Device Accessories ....................................................................................................................................
Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
comment on the draft best practices in
drug and biological product postmarket
safety surveillance.
[FR Doc. 2019–24263 Filed 11–6–19; 8:45 am]
DATES:
Submit either electronic or
written comments on the draft
document by January 6, 2020 to ensure
that the Agency considers your
comment on this draft document before
it begins work on the final version.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ADDRESSES:
Best Practices in Drug and Biological
Product Postmarket Safety
Surveillance for Food and Drug
Administration Staff; Draft Document;
Availability; Establishment of Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
establishment of public docket; request
for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments on a draft document that
details best practices for drug safety
surveillance entitled ‘‘Best Practices in
Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff.’’ The
21st Century Cures Act (Cures Act) was
enacted on December 13, 2016, and
requires that FDA make publicly
available on its internet website best
practices for drug safety surveillance
activities. The draft document sets forth
risk-based principles by which FDA
conducts ongoing postmarketing safety
surveillance for drug and biological
products to address the Cures Act
requirements. FDA is seeking public
SUMMARY:
VerDate Sep<11>2014
17:55 Nov 06, 2019
Jkt 250001
You may submit comments
as follows:
[Docket No. FDA–2019–N–3768]
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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9/30/2022
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0910–0650
0910–0654
9/30/2022
9/30/2022
0910–0673
0910–0684
9/30/2022
9/30/2022
0910–0746
0910–0823
9/30/2022
9/30/2022
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–
2019–N–3768 for ‘‘Best Practices in
Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff.’’
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
E:\FR\FM\07NON1.SGM
07NON1
Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Eileen Wu, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 3472, Silver Spring,
MD 20993–0002, 301–796–2345,
eileen.wu@fda.hhs.gov; or Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is establishing a public docket to
collect comments on a draft document
entitled ‘‘Best Practices in Drug and
Biological Product Postmarket Safety
Surveillance for FDA Staff.’’ Title IX,
section 915 of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) added a new section
505(r) to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(r)), requiring FDA to prepare a
summary analysis of the adverse drug
reaction reports received for a drug by
18 months after approval or after use of
the drug by 10,000 individuals,
whichever is later. The analysis
includes identification of any new risks
not previously identified, potential new
risks, or known risks reported in
unusual number.
The Cures Act (Pub. L. 114–255) was
enacted on December 13, 2016, and has
the goal of advancing medical product
VerDate Sep<11>2014
19:40 Nov 06, 2019
Jkt 250001
innovation, as well as ensuring patient
access to safe and effective treatments as
soon as possible. Section 3075 of the
Cures Act amended section 505(r)(2)(D)
of the FD&C Act to eliminate the
requirement for summary analyses for
drugs as required by FDAAA. In place
of the summary analyses, section 3075
amended section 505(r)(2)(D) of the
FD&C Act to include the requirement
that FDA make publicly available on its
internet website best practices for drug
safety surveillance activities for drugs
approved under section 505 of the FD&C
Act or section 351 of the Public Health
Service Act (PHS Act).
Section 3075 of the Cures Act also
amended section 505(k)(5) of the FD&C
Act to strike ‘‘bi-weekly screening’’, as
required by FDAAA, and insert
‘‘screenings’’; it also added the
requirement that FDA make publicly
available on its internet website
guidelines, developed with input from
experts qualified by scientific training
and experience to evaluate the safety
and effectiveness of drugs, that detail
best practices for drug safety
surveillance using the Adverse Event
Reporting System.
The draft document entitled ‘‘Best
Practices in Drug and Biological Product
Postmarket Safety Surveillance for FDA
Staff’’ sets forth risk-based principles by
which FDA conducts ongoing
postmarketing safety surveillance for
drug and biological products to address
the Cures Act requirements. Although
section 3075 of the Cures Act only
references drugs approved under section
505 of the FD&C Act or section 351 of
the PHS Act, the draft document
additionally provides a high-level
discussion regarding other products,
including over-the-counter monograph,
compounded, and homeopathic drug
products. The draft document also
includes a high-level overview of other
data sources, tools, and methods, as
well as drug safety surveillance
activities that extend beyond use of the
Adverse Event Reporting System (and
its successors). These additional topics
are included to provide context and a
general overview of FDA’s safety
surveillance process. FDA is seeking
public comment on the draft best
practices document before it begins
work on the final version, which will be
made publicly available.
II. Electronic Access
Persons with access to the internet
may obtain the draft document entitled
‘‘Best Practices in Drug and Biological
Product Postmarket Safety Surveillance
for FDA Staff’’ at https://www.fda.gov/
media/130216/download.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
60095
Dated: November 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–24332 Filed 11–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Healthy Start Evaluation
and Quality Improvement, OMB No.
0915–0338—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than December 9,
2019.
SUMMARY:
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Healthy Start Evaluation and Quality
Improvement. OMB No. 0915–0338—
Revision.
Abstract: The National Healthy Start
Program, funded through HRSA’s
Maternal and Child Health Bureau
(MCHB), has the goal of reducing racial
and ethnic disparities in infant
mortality and other adverse perinatal
outcomes. The program began as a
demonstration project with 15 grantees
in 1991 and since then has expanded to
101 grantees serving communities in 34
states, Washington, DC, and Puerto
ADDRESSES:
E:\FR\FM\07NON1.SGM
07NON1
Agencies
[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60094-60095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3768]
Best Practices in Drug and Biological Product Postmarket Safety
Surveillance for Food and Drug Administration Staff; Draft Document;
Availability; Establishment of Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; establishment of public docket; request
for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to collect comments on a draft document
that details best practices for drug safety surveillance entitled
``Best Practices in Drug and Biological Product Postmarket Safety
Surveillance for FDA Staff.'' The 21st Century Cures Act (Cures Act)
was enacted on December 13, 2016, and requires that FDA make publicly
available on its internet website best practices for drug safety
surveillance activities. The draft document sets forth risk-based
principles by which FDA conducts ongoing postmarketing safety
surveillance for drug and biological products to address the Cures Act
requirements. FDA is seeking public comment on the draft best practices
in drug and biological product postmarket safety surveillance.
DATES: Submit either electronic or written comments on the draft
document by January 6, 2020 to ensure that the Agency considers your
comment on this draft document before it begins work on the final
version.
ADDRESSES: You may submit comments 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-2019-N-3768 for ``Best Practices in Drug and Biological Product
Postmarket Safety Surveillance for FDA Staff.'' 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
[[Page 60095]]
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Eileen Wu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 3472, Silver Spring, MD 20993-0002, 301-796-2345,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is establishing a public docket to collect comments on a draft
document entitled ``Best Practices in Drug and Biological Product
Postmarket Safety Surveillance for FDA Staff.'' Title IX, section 915
of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
added a new section 505(r) to the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(r)), requiring FDA to prepare a summary
analysis of the adverse drug reaction reports received for a drug by 18
months after approval or after use of the drug by 10,000 individuals,
whichever is later. The analysis includes identification of any new
risks not previously identified, potential new risks, or known risks
reported in unusual number.
The Cures Act (Pub. L. 114-255) was enacted on December 13, 2016,
and has the goal of advancing medical product innovation, as well as
ensuring patient access to safe and effective treatments as soon as
possible. Section 3075 of the Cures Act amended section 505(r)(2)(D) of
the FD&C Act to eliminate the requirement for summary analyses for
drugs as required by FDAAA. In place of the summary analyses, section
3075 amended section 505(r)(2)(D) of the FD&C Act to include the
requirement that FDA make publicly available on its internet website
best practices for drug safety surveillance activities for drugs
approved under section 505 of the FD&C Act or section 351 of the Public
Health Service Act (PHS Act).
Section 3075 of the Cures Act also amended section 505(k)(5) of the
FD&C Act to strike ``bi-weekly screening'', as required by FDAAA, and
insert ``screenings''; it also added the requirement that FDA make
publicly available on its internet website guidelines, developed with
input from experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, that detail best
practices for drug safety surveillance using the Adverse Event
Reporting System.
The draft document entitled ``Best Practices in Drug and Biological
Product Postmarket Safety Surveillance for FDA Staff'' sets forth risk-
based principles by which FDA conducts ongoing postmarketing safety
surveillance for drug and biological products to address the Cures Act
requirements. Although section 3075 of the Cures Act only references
drugs approved under section 505 of the FD&C Act or section 351 of the
PHS Act, the draft document additionally provides a high-level
discussion regarding other products, including over-the-counter
monograph, compounded, and homeopathic drug products. The draft
document also includes a high-level overview of other data sources,
tools, and methods, as well as drug safety surveillance activities that
extend beyond use of the Adverse Event Reporting System (and its
successors). These additional topics are included to provide context
and a general overview of FDA's safety surveillance process. FDA is
seeking public comment on the draft best practices document before it
begins work on the final version, which will be made publicly
available.
II. Electronic Access
Persons with access to the internet may obtain the draft document
entitled ``Best Practices in Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff'' at https://www.fda.gov/media/130216/download.
Dated: November 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24332 Filed 11-6-19; 8:45 am]
BILLING CODE 4164-01-P