Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products, 5824-5827 [2022-02055]
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5824
Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
Data (OMB #0970–0389; expiration 6/
30/2022). There are minor updates to
the existing Form 1.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Section 511(h)(2)(A) of
Title V of the Social Security Act
ADDRESSES:
created the MIECHV Program and
authorizes the Secretary of HHS to
award grants to Indian tribes (or a
consortium of Indian tribes), tribal
organizations, or urban Indian
organizations to conduct an early
childhood home visiting program. The
legislation set aside 3 percent of the
total MIECHV program appropriation for
grants to tribal entities. Tribal MIECHV
grants, to the greatest extent practicable,
are to be consistent with the
requirements of the MIECHV grants to
states and jurisdictions and include
conducting a needs assessment and
establishing quantifiable, measurable
benchmarks. ACF’s OCC, in
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, awards grants
for the Tribal MIECHV Program. The
Tribal MIECHV grant awards support 5year cooperative agreements to conduct
community needs assessments; plan for
and implement high-quality, culturally
relevant, evidence-based home visiting
programs in at-risk tribal communities;
and participate in research and
evaluation activities to build the
knowledge base on home visiting among
Native populations.
In Year 1 of the cooperative
agreement, grantees must (1) conduct a
comprehensive community needs and
readiness assessment, and (2) develop a
plan to respond to identified needs.
Following each year that Tribal
MIECHV grantees implement home
visiting services, they must submit Form
1: Demographic and Service Utilization
Data. The Form 1 data are used to help
ACF better understand the population
receiving services from Tribal MIECHV
grantees and the degree to which they
are using services, as well as better
understand the Tribal MIECHV
workforce. Overall, this information
collection will provide valuable
information to HHS that will guide
understanding of the Tribal MIECHV
Program and the provision of technical
assistance to Tribal MIECHV Program
grantees. Changes from the previous
form are minor, including adding a
virtual home visit field and revising
certain terms and definitions to make
reporting on the areas more concise and
easier for grantees to report.
Respondents: Tribal MIECHV Program
Grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual number
of responses
per respondent
Average
burden hours
per response
Annual
burden hours
Tribal MIECHV Form 1 ..................................................................................
23
1
500
11,500
Estimated Total Annual Burden
Hours: 11,500.
Authority: Title V of the Social
Security Act, sections 511(e)(8)(A) and
511(h)(2)(A).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–02157 Filed 2–1–22; 8:45 am]
BILLING CODE 4184–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2012–D–0429]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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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
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 information
collection aspects of the ‘‘Guidance on
Meetings with Industry and
Investigators on the Research and
Development of Tobacco Products.’’
DATES: Submit either electronic or
written comments on the collection of
information by April 4, 2022.
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 April 4, 2022.
The https://www.regulations.gov
SUMMARY:
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electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 4, 2022. 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.
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
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
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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–
2012–D–0429 for ‘‘Guidance on
Meetings with Industry and
Investigators on the Research and
Development of Tobacco Products.’’
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, 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
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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.
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
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collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products
OMB Control Number 0910–0731—
Extension
The Family Smoking Prevention and
Tobacco Control Act (Pub. L. 111–31)
offers tobacco product manufacturers
several pathways to obtain an order
from FDA to authorize the marketing of
a new tobacco product before it may be
introduced or delivered into interstate
commerce. To provide assistance with
these pathways to market products, FDA
will meet with tobacco product
manufacturers, importers, researchers,
and investigators (or their
representatives) when appropriate as
described in ‘‘Guidance on Meetings
with Industry and Investigators on the
Research and Development of Tobacco
Products.’’ This guidance is intended to
assist persons who seek meetings with
FDA relating to their research to inform
the regulation of tobacco products, or to
support the development or marketing
of tobacco products. The original
guidance issued in 2012 was revised for
updating and clarity in July 2016.
In the guidance, the Agency
discusses, among other things:
• What information FDA
recommends persons include in a
meeting request;
• How and when to submit a request;
and
• What information FDA
recommends persons submit prior to a
meeting.
This guidance describes two
collections of information: (1) The
submission of a meeting request
containing certain information and (2)
the submission of an information
package in advance of the meeting. The
purpose of this proposed information
collection is to allow FDA to conduct
meetings with tobacco manufacturers,
importers, researchers, and investigators
in an effective and efficient manner.
FDA issued this guidance and the
revisions consistent with FDA’s good
guidance practices regulations (21 CFR
10.115).
Meeting Requests: The guidance sets
forth FDA’s recommendations for
materials to be included in a request for
a meeting with FDA to discuss the
research and development of tobacco
products. In the guidance, FDA
recommends that the following
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information be included in the meeting
request:
1. Product name
2. FDA-assigned Submission Tracking
Number(s) of prior submissions (e.g.,
premarket applications, meeting
requests) for the product and relevant
product version(s) (if applicable);
3. Product category (e.g., cigarettes,
smokeless tobacco) (if applicable);
4. Product use (indicate for consumer
use or for further manufacturing);
5. Contact information for the
authorized point of contact for the
company requesting the meeting;
6. The topic of the meeting being
requested (e.g., a new tobacco product
application, an application for
permission to market a modified risk
tobacco product, or investigational use
of a new tobacco product);
7. A brief statement of the purpose of
the meeting, which could include a
discussion of the types of studies or data
to be discussed at the meeting, the
general nature of the primary questions
to be asked, and where the meeting fits
in the overall product development
plans;
8. A preliminary list of the specific
objectives/outcomes expected from the
meeting;
9. A preliminary proposed agenda,
including an estimate of the time
needed and a designated speaker for
each agenda item;
10. A preliminary list of specific
critical questions, grouped by discipline
(e.g., chemistry, clinical, nonclinical);
11. A list of all individuals who will
attend the meeting on behalf of the
tobacco product manufacturer, importer,
researcher, or investigator, including
titles and responsibilities;
12. The date on which the meeting
information package will be received by
FDA; and
13. Suggested format of the meeting
(e.g., conference call, in-person meeting
at FDA offices, video conference, or
written response) and suggested dates
and times for the meeting. Meetings are
usually scheduled for 1 hour. FDA is
proposing a meeting request include the
FDA-assigned submission tracking
numbers of relevant product version(s),
if applicable, to allow for FDA to
reference such information to better
assess and respond to the issues and
questions raised in the meeting request.
This information will be used by the
Agency to: (1) Determine the utility of
the meeting, (2) identify Agency staff
necessary to discuss proposed agenda
items, and (3) schedule the meeting.
Meeting Information Packages: An
individual submitting a meeting
information package to FDA in advance
of a meeting should provide summary
information relevant to the product and
supplementary information pertaining
to any issue raised by the individual or
FDA to be discussed at the meeting. As
stated in the guidance, FDA
recommends that meeting information
packages generally include updates of
information that was submitted with the
meeting request and, as applicable:
1. Product composition and design
data summary;
2. Manufacturing and process control
data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data
summary;
6. User and nonuser perception data
summary; and
7. Investigational plans for studies
and surveillance of the tobacco product,
including a summary of proposed study
protocols containing the following
information (as applicable):
a. Study objective(s);
b. Study hypotheses;
c. Study design;
d. Study population (inclusion/
exclusion criteria, comparison group(s));
e. Human subject protection
information, including Institutional
Review Board information;
f. Primary and secondary endpoints
(definition and success criteria);
g. Sample size calculation;
h. Data collection procedures;
i. Duration of follow up and baseline
and follow up assessments, and
j. Data analysis plan(s).
The purpose of the information
package is to provide Agency staff the
opportunity to adequately prepare for
the meeting, including the review of
relevant data concerning the product. In
the Agency’s experience, reviewing
such information is critical to achieving
a productive meeting. If the information
package was previously submitted in
the meeting request, it should be
revised, as applicable, so that the
information reflects the most current
and accurate information available.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
Meeting Requests
Combining and Sending Meeting Request Letters for Manufacturers, Importers, and Researchers ..........................
60
1
60
10
600
Meeting Information Packages
Combining and Submitting Meeting Information Packages
for Manufacturers, Importers, and Researchers ..............
60
1
60
18
1,080
Total ..............................................................................
........................
........................
........................
........................
1,680
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents for meeting requests in
table 1 is based on the number of
meeting requests received and projected
over the next 3 years. FDA estimates
that 60 preapplication meetings will be
requested.
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The hours per response for combining
and sending meeting request letters are
estimated at 10 hours each, and the total
burden hours for meeting requests are
expected to be 600 hours. Based on
FDA’s experience, the Agency expects it
will take respondents this amount of
time to prepare, gather, copy, and
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submit brief statements about the
product and a description of the
purpose and details of the meeting.
FDA estimates that 60 respondents
will compile meeting information
packages and submit to FDA at 18 hours
per response. Based on FDA’s
experience, the Agency expects that it
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
will take respondents, collectively,
1,080 hours to gather, copy, and submit
brief statements about the product, a
description of the details of the
anticipated meeting, and data and
information, including identifying prior
FDA submissions for the product or
relevant versions of the product, that
generally would already have been
generated for the planned research and/
or product development.
The total number of burden hours for
this collection of information is
estimated to be 1,680 hours (600 hours
to prepare and submit meeting requests
and 1,080 hours to prepare and submit
information packages). Our estimated
burden for the information collection
reflects an overall decrease of 644 hours.
We attribute this adjustment to a
decrease in the number of submissions
we received over the last few years and
our projections for the next 3 years.
[FR Doc. 2022–02055 Filed 2–1–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0079]
Hikma Pharmaceuticals USA, Inc., et
al.; Withdrawal of Approval of 29 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 29 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
SUMMARY:
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
March 4, 2022.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 006134 ........................
Hikma Pharmaceuticals USA, Inc., 1809 Wilson Rd.,
Columbus, OH 43228.
NDA 006882 ........................
Dolophine (methadone hydrochloride (HCl)) Tablets, 5
milligrams (mg), and 10 mg.
Dolophine (methadone HCl) Syrup, 10 mg/30 milliliter
(mL).
Phisohex (hexachlorophene) Emulsion, 3% ...................
NDA 009818 ........................
Kemadrin (procyclidine HCl) Tablets, 2 mg, and 5 mg ..
NDA 012301 ........................
Librium (chlordiazepoxide HCl), Injection, 100 mg/ampule.
Norgesic (orphenadrine citrate, aspirin, and caffeine)
Tablets, 25 mg/385 mg/30 mg.
Norgesic Forte (orphenadrine citrate, aspirin, and caffeine) Tablets, 50 mg/770 mg/60 mg.
Spandin (aspirin and sodium salicylate) Time-released
Tablets, 7.5 grains/2.5 grains.
Talwin (pentazocine lactate) Injection, equivalent to
(EQ) 30 mg base/mL.
Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40
mg, 60 mg, 80 mg, and 90 mg.
Resectisol (mannitol) Irrigation Solution, 5 grams (g)/
100 mL.
Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40
mg, 60 mg, and 80 mg.
Micronor (norethindrone) Tablets, 0.35 mg ....................
NDA 013416 ........................
NDA 014228 ........................
NDA 016194 ........................
NDA 016418 ........................
NDA 016704 ........................
NDA 016762 ........................
NDA 016954 ........................
NDA 017013 ........................
NDA 017683 ........................
NDA 018423 ........................
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Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
5827
Sodium Chloride Injection, 20 g/100 mL ........................
Inderal (propranolol HCL) Tablets, 10 mg, 20 mg, 40
mg, 60 mg, and 80 mg.
Hibiclens (chlorhexidine gluconate) Sponge, 4% ...........
NDA 018703 ........................
Zantac (ranitidine HCl) Tablets, EQ 150 mg base, and
EQ 300 mg base.
NDA 019387 ........................
Profenal (suprofen) Ophthalmic Solution, 1% ................
NDA 019530 ........................
NDA 019675 ........................
Ucephan (sodium benzoate and sodium phenylacetate)
Solution, 100 mg/mL; 100 mg/mL.
Zantac (ranitidine HCl) Syrup, EQ 15 mg base/mL ........
NDA 019814 ........................
NDA 019927 ........................
Betagan (levobunolol HCl) Ophthalmic Solution, 0.25%
Nizoral (ketoconazole) Shampoo, 2% ............................
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Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
Monarch Pharmaceuticals, LLC, c/o Pfizer, Inc., 235
East 42nd St., New York, NY 10017.
Bausch Health US, LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
Bausch Health US, LLC.
Abbott Healthcare Pvt. Ltd., c/o G&L Scientific, Independence Blvd., 4th Floor, Warren, NJ 07059.
Hospira Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
Wyeth Pharmaceuticals LLC, 235 E. 42nd St., New
York, NY 10017.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
Wyeth Pharmaceuticals LLC.
Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Abbott Healthcare Pvt. Ltd., c/o G&L Scientific.
Wyeth Pharmaceuticals LLC.
Mo¨lnlycke Health Care, 5445 Triangle Pkwy., Suite
400, Peachtree Corners, GA 30092.
GlaxoSmithKline Intellectual Property Ltd. England, c/o
GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA
19112.
Alcon Laboratories, Inc., 6201 South Freeway, Fort
Worth, TX 76134–2099.
B. Braun Medical Inc.
GlaxoSmithKline Intellectual Property Ltd. England, c/o
GlaxoSmithKline.
Allergan, Inc.
Janssen Pharmaceuticals, Inc.
E:\FR\FM\02FEN1.SGM
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Agencies
[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5824-5827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02055]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0429]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Meetings With Industry and Investigators
on the Research and Development of Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 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 information collection aspects of the
``Guidance on Meetings with Industry and Investigators on the Research
and Development of Tobacco Products.''
DATES: Submit either electronic or written comments on the collection
of information by April 4, 2022.
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 April 4, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 4, 2022. 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.
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
[[Page 5825]]
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-2012-D-0429 for ``Guidance on Meetings with Industry and
Investigators on the Research and Development of Tobacco Products.''
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, 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: 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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance on Meetings With Industry and Investigators on the Research
and Development of Tobacco Products
OMB Control Number 0910-0731--Extension
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) offers tobacco product manufacturers several pathways to obtain an
order from FDA to authorize the marketing of a new tobacco product
before it may be introduced or delivered into interstate commerce. To
provide assistance with these pathways to market products, FDA will
meet with tobacco product manufacturers, importers, researchers, and
investigators (or their representatives) when appropriate as described
in ``Guidance on Meetings with Industry and Investigators on the
Research and Development of Tobacco Products.'' This guidance is
intended to assist persons who seek meetings with FDA relating to their
research to inform the regulation of tobacco products, or to support
the development or marketing of tobacco products. The original guidance
issued in 2012 was revised for updating and clarity in July 2016.
In the guidance, the Agency discusses, among other things:
What information FDA recommends persons include in a
meeting request;
How and when to submit a request; and
What information FDA recommends persons submit prior to a
meeting.
This guidance describes two collections of information: (1) The
submission of a meeting request containing certain information and (2)
the submission of an information package in advance of the meeting. The
purpose of this proposed information collection is to allow FDA to
conduct meetings with tobacco manufacturers, importers, researchers,
and investigators in an effective and efficient manner. FDA issued this
guidance and the revisions consistent with FDA's good guidance
practices regulations (21 CFR 10.115).
Meeting Requests: The guidance sets forth FDA's recommendations for
materials to be included in a request for a meeting with FDA to discuss
the research and development of tobacco products. In the guidance, FDA
recommends that the following
[[Page 5826]]
information be included in the meeting request:
1. Product name
2. FDA-assigned Submission Tracking Number(s) of prior submissions
(e.g., premarket applications, meeting requests) for the product and
relevant product version(s) (if applicable);
3. Product category (e.g., cigarettes, smokeless tobacco) (if
applicable);
4. Product use (indicate for consumer use or for further
manufacturing);
5. Contact information for the authorized point of contact for the
company requesting the meeting;
6. The topic of the meeting being requested (e.g., a new tobacco
product application, an application for permission to market a modified
risk tobacco product, or investigational use of a new tobacco product);
7. A brief statement of the purpose of the meeting, which could
include a discussion of the types of studies or data to be discussed at
the meeting, the general nature of the primary questions to be asked,
and where the meeting fits in the overall product development plans;
8. A preliminary list of the specific objectives/outcomes expected
from the meeting;
9. A preliminary proposed agenda, including an estimate of the time
needed and a designated speaker for each agenda item;
10. A preliminary list of specific critical questions, grouped by
discipline (e.g., chemistry, clinical, nonclinical);
11. A list of all individuals who will attend the meeting on behalf
of the tobacco product manufacturer, importer, researcher, or
investigator, including titles and responsibilities;
12. The date on which the meeting information package will be
received by FDA; and
13. Suggested format of the meeting (e.g., conference call, in-
person meeting at FDA offices, video conference, or written response)
and suggested dates and times for the meeting. Meetings are usually
scheduled for 1 hour. FDA is proposing a meeting request include the
FDA-assigned submission tracking numbers of relevant product
version(s), if applicable, to allow for FDA to reference such
information to better assess and respond to the issues and questions
raised in the meeting request.
This information will be used by the Agency to: (1) Determine the
utility of the meeting, (2) identify Agency staff necessary to discuss
proposed agenda items, and (3) schedule the meeting.
Meeting Information Packages: An individual submitting a meeting
information package to FDA in advance of a meeting should provide
summary information relevant to the product and supplementary
information pertaining to any issue raised by the individual or FDA to
be discussed at the meeting. As stated in the guidance, FDA recommends
that meeting information packages generally include updates of
information that was submitted with the meeting request and, as
applicable:
1. Product composition and design data summary;
2. Manufacturing and process control data summary;
3. Nonclinical data summary;
4. Clinical data summary;
5. Behavioral and product use data summary;
6. User and nonuser perception data summary; and
7. Investigational plans for studies and surveillance of the
tobacco product, including a summary of proposed study protocols
containing the following information (as applicable):
a. Study objective(s);
b. Study hypotheses;
c. Study design;
d. Study population (inclusion/exclusion criteria, comparison
group(s));
e. Human subject protection information, including Institutional
Review Board information;
f. Primary and secondary endpoints (definition and success
criteria);
g. Sample size calculation;
h. Data collection procedures;
i. Duration of follow up and baseline and follow up assessments,
and
j. Data analysis plan(s).
The purpose of the information package is to provide Agency staff
the opportunity to adequately prepare for the meeting, including the
review of relevant data concerning the product. In the Agency's
experience, reviewing such information is critical to achieving a
productive meeting. If the information package was previously submitted
in the meeting request, it should be revised, as applicable, so that
the information reflects the most current and accurate information
available.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Meeting Requests
----------------------------------------------------------------------------------------------------------------
Combining and Sending Meeting 60 1 60 10 600
Request Letters for
Manufacturers, Importers, and
Researchers....................
----------------------------------------------------------------------------------------------------------------
Meeting Information Packages
----------------------------------------------------------------------------------------------------------------
Combining and Submitting Meeting 60 1 60 18 1,080
Information Packages for
Manufacturers, Importers, and
Researchers....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,680
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA's estimate of the number of respondents for meeting requests in
table 1 is based on the number of meeting requests received and
projected over the next 3 years. FDA estimates that 60 preapplication
meetings will be requested.
The hours per response for combining and sending meeting request
letters are estimated at 10 hours each, and the total burden hours for
meeting requests are expected to be 600 hours. Based on FDA's
experience, the Agency expects it will take respondents this amount of
time to prepare, gather, copy, and submit brief statements about the
product and a description of the purpose and details of the meeting.
FDA estimates that 60 respondents will compile meeting information
packages and submit to FDA at 18 hours per response. Based on FDA's
experience, the Agency expects that it
[[Page 5827]]
will take respondents, collectively, 1,080 hours to gather, copy, and
submit brief statements about the product, a description of the details
of the anticipated meeting, and data and information, including
identifying prior FDA submissions for the product or relevant versions
of the product, that generally would already have been generated for
the planned research and/or product development.
The total number of burden hours for this collection of information
is estimated to be 1,680 hours (600 hours to prepare and submit meeting
requests and 1,080 hours to prepare and submit information packages).
Our estimated burden for the information collection reflects an overall
decrease of 644 hours. We attribute this adjustment to a decrease in
the number of submissions we received over the last few years and our
projections for the next 3 years.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02055 Filed 2-1-22; 8:45 am]
BILLING CODE 4164-01-P