Notice2021-13597
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
Primary source
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Published
June 25, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, we, or Agency) 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 86 Issue 120 (Friday, June 25, 2021)</title>
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[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33717-33718]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13597]
[[Page 33717]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0525]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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, we, or Agency) 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 26, 2021.
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#1a4a485b496e7b7c7c5a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="f6a6a4b7a582979090b6909297d89e9e85d8919980">[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; Administrative Procedures, Policies, and
Requirements--21 CFR Part 203
OMB Control Number 0910-0435--Extension
This information collection supports FDA regulations codified at
part 203 (21 CFR part 203) implementing the Prescription Drug Marketing
Act of 1987 (PDMA) and the Prescription Drug Amendments of 1992. The
Federal Food, Drug, and Cosmetic Act, as amended by the PDMA,
establishes requirements for the following:
<bullet> Reimportation of prescription drugs.
<bullet> The sale, purchase, or trade of or the offer to sell,
purchase, or trade, prescription drugs that were purchased by hospitals
or health care entities or donated to charitable organizations.
<bullet> The distribution of prescription drug samples by mail,
common carrier, or another means of distribution.
<bullet> Applications for reimportation to provide emergency
medical care.
<bullet> An appeal from an adverse decision by the district office.
<bullet> Drug sample storage and handling.
<bullet> Fulfillment houses, shipping and mailing services,
comarketing agreements, and third-party recordkeeping.
<bullet> Donation of drug samples to charitable institutions.
The PDMA was enacted, in part, because insufficient safeguards
existed over the drug distribution system to prevent the introduction
and retail sale of substandard, ineffective, or counterfeit drugs. The
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.
The applicable regulations in part 203 include reporting and
recordkeeping requirements intended to help achieve the following
goals: (1) To 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) to ban the sale,
purchase, or trade, or the offer to sell, purchase, or trade, of any
prescription drug sample; (3) to 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) to require licensed or
authorized practitioners to request prescription drug samples in
writing; (5) to mandate storage, handling, and recordkeeping
requirements for prescription drug samples; and (6) to 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.
In the Federal Register of March 12, 2021 (86 FR 14128), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection 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
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203.11; reimportation 1 1 1 0.5 (30 minutes) \2\ 1
applications.
203.37(a); falsification of 140 21.4 3,000 0.25 (15 750
records. minutes).
203.37(b); loss or theft of 140 178.57 25,000 0.25 (15 6,250
samples. minutes).
203.37(c); conviction of 1 1 1 1............... 1
representatives.
203.37(d); contact person..... 20 1 20 0.25 (15 5
minutes).
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Total..................... .............. .............. 28,022 ................ 7,007
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest whole number.
[[Page 33718]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Number of records per Total annual Average burden
21 CFR section; activity recordkeepers recordkeeper records per Total hours
\2\ recordkeeping
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Subpart C: Sales restrictions
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203.23(a) and (b); returns.. 2,200 71.9909 158,380 0.25 (15 39,595
minutes).
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203.23(c); documentation of 2,200 71.9909 158,380 0.08 (~6 12,670
storage of returns. minutes).
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Subpart D: Samples
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203.30-203.39; documentation 140 202 28,280 ~.07-.08 (~4-5 2,121
regarding sample minutes).
distributions.
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Total................... ............... ............... 345,040 ............... 54,386
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest whole number.
Based on a review of Agency data, we assume 2,200 respondents may
incur burden resulting from the information collection activity
associated with the requirements in Sec. 203.23(a) through (c). A
total of 140 pharmaceutical companies have submitted information to the
Agency on drug sample distribution under part 203. Those same
respondents also have recordkeeping requirements under part 203. Our
estimate of the burden of the average burden per recordkeeping reflects
a cumulative average to cover all applicable requirements. Since our
last request for OMB approval, we have adjusted our estimate of the
overall burden downward to reflect a decrease of 2,567,713 hours and
64,432,232 records annually. We attribute this adjustment to a more
accurate reflection of the number of respondents to the information
collection and clarification that burden attributable to requirements
of the Drug Quality and Security Act are not included in this
information collection.
Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13597 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P
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