Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements, 3928-3930 [2024-01079]
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Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices
Under
section 565A of the FD&C Act (21 U.S.C.
360bbb-4a), FDA will report the
issuance of material threat MCM
priority review vouchers and the
approval of products for which a
voucher was redeemed. FDA has
determined that the application for
QULIPTA (atogepant) tablets, approved
September 28, 2021, meets the
redemption criteria.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For
further information about QULIPTA
(atogepant) tablets go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01108 Filed 1–19–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5451]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Marketing: Administrative Procedures,
Policies, and Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 information
collection associated with Agency
regulations that govern prescription
drug marketing.
DATES: Either electronic or written
comments on the collection of
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:02 Jan 19, 2024
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information must be submitted by
March 22, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 22, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received 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
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–
2023–N–5451 for ‘‘Prescription Drug
Marketing: Administrative Procedures,
Policies, and Requirements.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
PO 00000
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Fmt 4703
Sfmt 4703
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–976–5733, 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
E:\FR\FM\22JAN1.SGM
22JAN1
Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices
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.
Prescription Drug Marketing:
Administrative Procedures, Policies,
and Requirements—21 CFR Part 203
OMB Control Number 0910–0435—
Extension
This information collection helps
support FDA regulations. Specifically,
the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Prescription Drug Marketing Act of 1987
(Pub. L. 100–293) (PDMA) and
Prescription Drug Amendments of 1992,
establishes requirements for the: (1)
reimportation and wholesale
distribution of prescription drugs; (2)
sale, purchase, or trade of, or the offer
to sell, purchase, or trade, prescription
drugs that were purchased by hospitals
or healthcare entities or donated to
charitable organizations; and (3)
distribution of prescription drug
samples. Because insufficient safeguards
existed over the drug distribution
system to prevent the introduction and
retail sale of substandard, ineffective, or
counterfeit drugs, and that a wholesale
drug diversion submarket had
developed that prevented effective
control over the true sources of drugs,
PDMA was enacted. PDMA is intended
to ensure that drug products purchased
by consumers are safe and effective and
to avoid an unacceptable risk that
counterfeit, adulterated, misbranded,
subpotent, or expired drugs are sold.
Requirements under PDMA are codified
at part 203 (21 CFR part 203),
Prescription Drug Marketing.
3929
The regulations in part 203 include
reporting and recordkeeping
requirements intended to help achieve
the following goals to: (1) ban the
reimportation of prescription drugs
produced in the United States, except
when reimported by the manufacturer
or under FDA authorization for
emergency medical care; (2) ban the
sale, purchase, or trade, or the offer to
sell, purchase, or trade, of any
prescription drug sample; (3) limit the
distribution of drug samples to
practitioners licensed or authorized to
prescribe such drugs or to pharmacies of
hospitals or other healthcare entities at
the request of a licensed or authorized
practitioner; (4) require licensed or
authorized practitioners to request
prescription drug samples in writing; (5)
mandate storage, handling, and
recordkeeping requirements for
prescription drug samples; and (6)
prohibit, with certain exceptions, the
sale, purchase, or trade, or the offer to
sell, purchase, or trade, of prescription
drugs that were purchased by hospitals
or other healthcare entities or that were
donated or supplied at a reduced price
to a charitable organization.
Respondents: Respondents to the
information collection are persons or
entities engaged in prescription drug
marketing as described in FDA
regulations at part 203.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours 2
§ 203.11; Reimportation ........................................
§ 203.37(a); Falsification of records .....................
§ 203.37(b); Loss or theft of samples ...................
§ 203.37(c); Convictions .......................................
§ 203.37(d); Contact person .................................
§ 203.39(g); Reconciliation report .........................
1
140
140
1
20
1
1
2.14
57.14
1
1
1
1
300
8,000
1
20
1
0.5 (30 minutes) ...........
0.25 (15 minutes) .........
0.25 (15 minutes) .........
1 ....................................
0.08 (5 minutes) ...........
1 ....................................
0.5
75
2,000
1
2
1
Total ...............................................................
........................
........................
8,323
.......................................
2,080
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
ddrumheller on DSK120RN23PROD with NOTICES1
21 CFR section activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Subpart C: Sale restrictions
§ 203.23(a) and (b); Returned drugs ....................
§ 203.23(c); Returned drugs storage documentation.
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PO 00000
2,200
2,200
Frm 00025
Fmt 4703
71.99
71.99
Sfmt 4703
158,380
158,380
E:\FR\FM\22JAN1.SGM
0.25 (15 minutes) .........
0.08 (5 minutes) ...........
22JAN1
39,595
12,670
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Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Subpart D: Samples
§§ 203.30 to 203.39; documentation regarding
sample distribution.
140
46,716.67
6,540,334
0.08 (5 minutes) ...........
523,227
Total ...............................................................
........................
........................
6,857,094
.......................................
575,492
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency data,
since our last request for OMB approval,
we have adjusted our estimate of 1
burden to reflect an increase of
6,492,354 responses and 516,028 hours
annually. The estimates in table 1 (a
decrease of 19,700 responses and 4,928
hours since the last OMB approval)
reflect an assessment of the volume of
loss/theft/falsification reports received
by the Agency under § 203.37 over the
past 18 months. While the requirements
have not changed, we believe this more
accurately reflects the number of reports
estimated to be submitted to FDA under
this section. Our adjustments to table 2
are attributable to a more accurate
reflection of the number of drug sample
requests received by manufacturers and
authorized distributors of record. The
PDMA does not require manufacturers
and distributors to report the number of
drug sample requests they receive to
FDA. However, section 6004 of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148) requires that
manufacturers and authorized
distributors submit to FDA annually the
identity and quantity of drug samples
requested, among other information.
Dated: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01079 Filed 1–19–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2023–N–0008]
Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting—TriClip
G4 System
AGENCY:
Food and Drug Administration,
announces a forthcoming public
advisory committee meeting of the
Circulatory System Devices Panel of the
Medical Devices Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will take place
virtually on February 13, 2024, from 9
a.m. to 6 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions,
including information regarding special
accommodations due to a disability,
may be accessed at: https://
www.fda.gov/advisory-committees/
about-advisory-committees/commonquestions-and-answers-about-fdaadvisory-committee-meetings.
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 66, Rm. 5214, Silver Spring,
MD 20993–0002, Akinola.Awojope@
fda.hhs.gov, 301–636–0512, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
SUMMARY:
VerDate Sep<11>2014
18:02 Jan 19, 2024
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Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On February
PO 00000
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Fmt 4703
Sfmt 4703
13, 2024, the committee will discuss,
make recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
TriClip G4 System by Abbott Medical.
The proposed Indication for Use
statement is as follows: The TriClip G4
System is indicated for the
improvement of health status in patients
with symptomatic severe tricuspid
regurgitation despite being treated
optimally with medical therapy, who
are at intermediate or greater risk for
surgery and in whom tricuspid valve
edge-to-edge repair is appropriate as
determined by a heart team.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down and select the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 2, 2024.
Oral presentations from the public will
be scheduled on February 13, 2024,
between approximately 1 p.m. and 2
p.m. Eastern Time. Those individuals
interested in making formal oral
presentations should notify the contact
person (see FOR FURTHER INFORMATION
CONTACT). The notification should
include a brief statement of the general
nature of the evidence or arguments
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 89, Number 14 (Monday, January 22, 2024)]
[Notices]
[Pages 3928-3930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5451]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Marketing: Administrative
Procedures, Policies, and Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 information collection
associated with Agency regulations that govern prescription drug
marketing.
DATES: Either electronic or written comments on the collection of
information must be submitted by March 22, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 22, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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 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-2023-N-5451 for ``Prescription Drug Marketing: Administrative
Procedures, Policies, and Requirements.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-976-5733,
[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
[[Page 3929]]
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.
Prescription Drug Marketing: Administrative Procedures, Policies, and
Requirements--21 CFR Part 203
OMB Control Number 0910-0435--Extension
This information collection helps support FDA regulations.
Specifically, the Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Prescription Drug Marketing Act of 1987 (Pub. L. 100-
293) (PDMA) and Prescription Drug Amendments of 1992, establishes
requirements for the: (1) reimportation and wholesale distribution of
prescription drugs; (2) sale, purchase, or trade of, or the offer to
sell, purchase, or trade, prescription drugs that were purchased by
hospitals or healthcare entities or donated to charitable
organizations; and (3) distribution of prescription drug samples.
Because insufficient safeguards existed over the drug distribution
system to prevent the introduction and retail sale of substandard,
ineffective, or counterfeit drugs, and that a wholesale drug diversion
submarket had developed that prevented effective control over the true
sources of drugs, PDMA was enacted. PDMA is intended to ensure that
drug products purchased by consumers are safe and effective and to
avoid an unacceptable risk that counterfeit, adulterated, misbranded,
subpotent, or expired drugs are sold. Requirements under PDMA are
codified at part 203 (21 CFR part 203), Prescription Drug Marketing.
The regulations in part 203 include reporting and recordkeeping
requirements intended to help achieve the following goals to: (1) ban
the reimportation of prescription drugs produced in the United States,
except when reimported by the manufacturer or under FDA authorization
for emergency medical care; (2) ban the sale, purchase, or trade, or
the offer to sell, purchase, or trade, of any prescription drug sample;
(3) limit the distribution of drug samples to practitioners licensed or
authorized to prescribe such drugs or to pharmacies of hospitals or
other healthcare entities at the request of a licensed or authorized
practitioner; (4) require licensed or authorized practitioners to
request prescription drug samples in writing; (5) mandate storage,
handling, and recordkeeping requirements for prescription drug samples;
and (6) prohibit, with certain exceptions, the sale, purchase, or
trade, or the offer to sell, purchase, or trade, of prescription drugs
that were purchased by hospitals or other healthcare entities or that
were donated or supplied at a reduced price to a charitable
organization.
Respondents: Respondents to the information collection are persons
or entities engaged in prescription drug marketing as described in FDA
regulations at part 203.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \2\
----------------------------------------------------------------------------------------------------------------
Sec. 203.11; Reimportation.. 1 1 1 0.5 (30 minutes) 0.5
Sec. 203.37(a); 140 2.14 300 0.25 (15 75
Falsification of records. minutes).
Sec. 203.37(b); Loss or 140 57.14 8,000 0.25 (15 2,000
theft of samples. minutes).
Sec. 203.37(c); Convictions. 1 1 1 1............... 1
Sec. 203.37(d); Contact 20 1 20 0.08 (5 minutes) 2
person.
Sec. 203.39(g); 1 1 1 1............... 1
Reconciliation report.
---------------------------------------------------------------------------------
Total..................... .............. .............. 8,323 ................ 2,080
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart C: Sale restrictions
----------------------------------------------------------------------------------------------------------------
Sec. 203.23(a) and (b); 2,200 71.99 158,380 0.25 (15 39,595
Returned drugs. minutes).
Sec. 203.23(c); Returned 2,200 71.99 158,380 0.08 (5 minutes) 12,670
drugs storage documentation.
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[[Page 3930]]
Subpart D: Samples
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 203.30 to 203.39; 140 46,716.67 6,540,334 0.08 (5 minutes) 523,227
documentation regarding
sample distribution.
---------------------------------------------------------------------------------
Total..................... .............. .............. 6,857,094 ................ 575,492
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of Agency data, since our last request for OMB
approval, we have adjusted our estimate of 1 burden to reflect an
increase of 6,492,354 responses and 516,028 hours annually. The
estimates in table 1 (a decrease of 19,700 responses and 4,928 hours
since the last OMB approval) reflect an assessment of the volume of
loss/theft/falsification reports received by the Agency under Sec.
203.37 over the past 18 months. While the requirements have not
changed, we believe this more accurately reflects the number of reports
estimated to be submitted to FDA under this section. Our adjustments to
table 2 are attributable to a more accurate reflection of the number of
drug sample requests received by manufacturers and authorized
distributors of record. The PDMA does not require manufacturers and
distributors to report the number of drug sample requests they receive
to FDA. However, section 6004 of the Patient Protection and Affordable
Care Act (Pub. L. 111-148) requires that manufacturers and authorized
distributors submit to FDA annually the identity and quantity of drug
samples requested, among other information.
Dated: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01079 Filed 1-19-24; 8:45 am]
BILLING CODE 4164-01-P
