[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]


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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 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:
    <bullet> 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.
    <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 https://www.regulations.gov 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 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, 
<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.
                               ---------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                   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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[[Page 3930]]

 
                                               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.
                               ---------------------------------------------------------------------------------
    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


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