2018-11113. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements  

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    Food and Drug Administration, HHS.




    The Food and Drug Administration (FDA) 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.


    Fax written comments on the collection of information by June 25, 2018.


    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0435. Also include the FDA docket number found in brackets in the heading of this document.

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    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, PRAStaff@fda.hhs.gov.

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    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 Act of 1987—Administrative Procedures, Policies, and Requirements

    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). The PDMA was intended to ensure safe and effective drug products and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold to consumers. The reporting and recordkeeping requirements found in the regulations are 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; (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; and (7) to require unauthorized wholesale distributors to provide, prior to the wholesale distribution of a prescription drug to another wholesale distributor or retail pharmacy, a statement identifying each prior sale, purchase, or trade of the drug.

    In the Federal Register of December 14, 2017 (82 FR 58808), we published a notice soliciting public comment of the information collection. One caller responded to the notice asking about the impact the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality Security Act of 2013) has on the information collection. We note that the Agency is currently proposing to amend its regulations at part 203 to reflect changes resulting from enactment of the DSCSA (RIN 0910-AH56). While we expect these changes will result in a reduction of burden associated with the information collection, current regulations and associated information collection requirements remain in effect. Upon finalization of rulemaking, we will revise the information collection accordingly.

    We therefore estimate the burden for the information collection as follows:Start Printed Page 24128

    Table 1—Estimated Annual Reporting Burden 1

    21 CFR section/a ctivityNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
    203.11—Reimportation1110.5 (30 minutes)1
    203.30(a)(1) and (b)—Drug sample requests61,96112743,5320.06 (4 minutes)44,612
    203.30(a)(3), (a)(4), and (c)—Drug sample receipts61,96112743,5320.06 (4 minutes)44,612
    203.31(a)(1) and (b)—Drug sample requests232,35513531,367,9250.04 (2.5 minutes)1,254,717
    203.31(a)(3), (a)(4), and (c)—Drug sample receipts232,35513531,367,9250.03 (2 minutes)941,038
    203.37(a)—Falsification of records5042000.25 (15 minutes)50
    203.37(b)—Loss or theft of samples50402,0000.25 (15 minutes)500
    203.37(d)—Contact person501500.08 (5 minutes)4
    203.39(g)—Reconciliation report11111
    1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2—Estimated Annual Recordkeeping Burden 1

    21 CFR Section/ActivityNumber of recordkeepersNumber of records per recordkeeperTotal annual recordsAverage burden per recordkeepingTotal hours
    203.23(a) and (b)—Returned drugs31,6765158,3800.25 (15 minutes)39,595
    203.23(c)—Returned drugs documentation31,6765158,3800.08 (5 minutes)12,670
    203.30(a)(2) and 203.31(a)(2)—Practitioner verification2,208100220,8000.5 (30 minutes)110,400
    203.31(d)(1) and (2)—Inventory record and reconciliation report2,20812,2084088,320
    203.31(d)(4)—Investigation of discrepancies and losses44214422410,608
    203.31(e)—Representatives lists2,20812,20812,208
    203.34—Administrative systems90190403,600
    203.37(a)—Falsification of drug sample records50420061,200
    203.37(b)—Loss or theft of drug samples50402,000612,000
    203.39(d)—Destroyed or returned drug samples65165165
    203.39(e)—Donated drug samples3,22113,2210.5 (30 minutes)1,611
    203.39(f)—Distribution of donated drug samples3,22113,221825,768
    203.39(g)—Drug samples donated to charitable institutions3,22113,221825,768
    203.50(a)—Drug origin statement12510012,5000.17 (10 minutes)2,125
    203.50(b)—Drug origin statement retention12510012,5000.5 (30 minutes)6,250
    203.50(d)—Authorized distributors of record691169121,382
    1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of Agency data, we retain the currently approved burden estimate for the information collection, as reflected in tables 1 and 2 above.

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    Dated: May 18, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

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    [FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Health and Human Services Department
Food and Drug Administration
Document Number:
Fax written comments on the collection of information by June 25, 2018.
24127-24128 (2 pages)
Docket Numbers:
Docket No. FDA-2011-N-0279
PDF File: