Notice2024-01079
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements
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Published
January 22, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 14 (Monday, January 22, 2024)</title>
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[Federal Register Volume 89, Number 14 (Monday, January 22, 2024)]
[Notices]
[Pages 3928-3930]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01079]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="8bdbd9cad8ffeaededcbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a>.
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\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \2\
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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.
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Total..................... .............. .............. 8,323 ................ 2,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR section activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Subpart C: Sale restrictions
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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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Subpart D: Samples
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Sec. Sec. 203.30 to 203.39; 140 46,716.67 6,540,334 0.08 (5 minutes) 523,227
documentation regarding
sample distribution.
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Total..................... .............. .............. 6,857,094 ................ 575,492
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\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
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