[Federal Register Volume 89, Number 110 (Thursday, June 6, 2024)]
[Notices]
[Pages 48431-48432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12357]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of       Total
    21 CFR section; activity        Number of      responses per    annual       Average  burden per      Total
                                   respondents      respondent     responses          response            hours
----------------------------------------------------------------------------------------------------------------
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.
                                --------------------------------------------------------------------------------
    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       Total
    21 CFR section; activity        Number of       records per     annual       Average burden per       Total
                                  recordkeepers    recordkeeper     records         recordkeeping         hours
----------------------------------------------------------------------------------------------------------------
                                          Subpart C: Sale restrictions
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
                                               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, 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