Notice2024-12357
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 89 Issue 110 (Thursday, June 6, 2024)</title>
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[Federal Register Volume 89, Number 110 (Thursday, June 6, 2024)]
[Notices]
[Pages 48431-48432]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12357]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5451]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Marketing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 8, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0435. Also include the FDA docket
number found in brackets in the heading of this document.
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, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#217173607255404747614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="e4b4b6a5b790858282a4828085ca8c8c97ca838b92">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Prescription Drug Marketing
OMB Control Number 0910-0435--Extension
This information collection helps support FDA regulations and
statutory requirements that govern prescription drug marketing.
Specifically, the Federal Food, Drug, and Cosmetic 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. Agency regulations implementing PDMA
requirements are codified in part 203
[[Page 48432]]
(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.
In the Federal Register of January 22, 2024 (89 FR 3928), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four information collection topics solicited in
our 60-day notice.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
21 CFR section; activity Number of responses per annual Average burden per Total
respondents respondent responses response hours
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Sec. 203.11; Reimportation... 1 1 1 0.5 (30 minutes)........ 0.5
Sec. 203.37(a); Falsification 140 2.14 300 0.25 (15 minutes)....... 75
of records.
Sec. 203.37(b); Loss or theft 140 57.14 8,000 0.25 (15 minutes)....... 2,000
of samples.
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 Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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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 minutes)....... 39,595
Returned drugs.
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, cumulatively our estimate reflects an increase of 6,492,354
responses and 516,028 hours annually. The estimates in table 1 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 the current figures
more accurately reflect 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: May 31, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12357 Filed 6-5-24; 8:45 am]
BILLING CODE 4164-01-P
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