[Federal Register Volume 67, Number 231 (Monday, December 2, 2002)]
[Notices]
[Pages 71572-71574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0486]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prescription Drug Marketing Act of 1987

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 the reporting and 
recordkeeping requirements contained in the regulations implementing 
the Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100-
293).

DATES: Submit written or electronic comments on the collection of 
information by January 31, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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: (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 Act of 1987; Administrative Procedures, 
Policies, and Requirements--21 CFR part 3 (OMB Control Number 0910-
0435)--Extension

    FDA is requesting OMB approval under the PRA for the reporting and 
recordkeeping requirements contained in the regulations implementing 
PDMA. PDMA was intended to ensure that drug products purchased by 
consumers are safe and effective and to avoid an unacceptable risk of 
counterfeit, adulterated, misbranded, subpotent, or expired drugs are 
sold.
    PDMA was enacted by Congress because there were insufficient 
safeguards in the drug distribution system to prevent the introduction 
and retail sale of substandard, ineffective, or counterfeit drugs, and 
a wholesale drug diversion submarket had developed that prevented 
effective control over the true sources of drugs.
    Congress found that large amounts of drugs had been reimported into 
the United States as American goods returned causing a health and 
safety risk to American consumers because the drugs may become 
subpotent or adulterated during foreign handling and shipping. Congress 
also found that a ready market for prescription drug reimports had been 
the catalyst for a continuing series of frauds against American 
manufacturers and had

[[Page 71573]]

provided the cover for the importation of foreign counterfeit drugs.
    Congress also determined that the system of providing drug samples 
to physicians through manufacturers' representatives had resulted in 
the sale to consumers of misbranded, expired, and adulterated 
pharmaceuticals.
    The bulk resale of below-wholesale priced prescription drugs by 
health care entities for ultimate sale at retail also helped to fuel 
the diversion market and was an unfair form of competition to 
wholesalers and retailers who had to pay otherwise prevailing market 
prices.
    FDA is requesting OMB approval for the following reporting and 
recordkeeping requirements:

           Table 1.--Reporting and Recordkeeping Requirements
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        21 CFR Section                        Requirements
------------------------------------------------------------------------
203.11                          Applications for reimportation to
                                 provide emergency medical care.
203.30(a)(1) and (b)            Drug sample requests (drug samples
                                 distributed by mail or common carrier).
203.30(a)(3), (a)(4), and (c)   Drug sample receipts (receipts for drug
                                 samples distributed by mail or common
                                 carrier).
203.31(a)(1) and (b)            Drug sample requests (drug samples
                                 distributed by means other than the
                                 mail or a common carrier).
203.31(a)(3), (a)(4), and (c)   Drug sample receipts (drug samples
                                 distributed by means other than the
                                 mail or a common carrier).
203.37(a)                       Investigation of falsification of drug
                                 sample records.
203.37(b)                       Investigation of a significant loss or
                                 known theft of drug samples.
203.37(c)                       Notification that a representative has
                                 been convicted of certain offenses
                                 involving drug samples.
203.37(d)                       Notification of the individual
                                 responsible for responding to a request
                                 for information about drug samples.
203.38(a)                       Printing lot or control numbers on the
                                 drug sample unit label.
203.39(g)                       Preparation by a charitable institution
                                 of a reconciliation report for donated
                                 drug samples.
203.50(a)                       Drug origin statement.
203.23(a) and (b)               Credit memo for returned drugs.
203.23(c)                       Documentation of proper storage,
                                 handling, and shipping conditions for
                                 returned drugs.
203.30(a)(2) and                Verification that a practitioner
203.31(a)(2)                     requesting a drug sample is licensed or
                                 authorized to prescribe the product.
203.31(d)(1) and (d)(2)         Contents of the inventory record and
                                 reconciliation report required for drug
                                 samples distributed by representatives.
203.31(d)(4)                    Investigation of apparent discrepancies
                                 and significant losses revealed through
                                 the reconciliation report.
203.31(e)                       Lists of manufacturers' and
                                 distributors' representatives.
203.34                          Written policies and procedures
                                 describing administrative systems.
203.37(a)                       Report of investigation of falsification
                                 of drug sample records.
203.37(b)                       Report of investigation of significant
                                 loss or known theft of drug samples.
203.38(b)                       Records of drug sample distribution
                                 identifying lot or control numbers of
                                 samples distributed.
203.39(d)                       Records of drug samples destroyed or
                                 returned by a charitable institution.
203.39(e)                       Record of drug samples donated to a
                                 charitable institution.
203.39(f)                       Records of donation and distribution or
                                 other disposition of donated drug
                                 samples.
203.39(g)                       Inventory and reconciliation of drug
                                 samples donated to charitable
                                 institutions.
203.50(a)                       Drug origin statement.
203.50(b)                       Retention of drug origin statement for 3
                                 years.
203.50(d)                       List of authorized distributors of
                                 record.
------------------------------------------------------------------------

    The reporting and recordkeeping requirements 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 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 health care entities at the request of a licensed or 
authorized practitioner;
    (4) To require licensed or authorized practitioners to request 
samples in writing;
    (5) To mandate storage, handling, and recordkeeping requirements 
for drug samples;
    (6) To prohibit, with certain exceptions, the sale, purchase, or 
trade of, or the offer to sell, purchase, or trade, prescription drugs 
that were purchased by hospitals or other health care entities, or 
which were donated or supplied at a reduced price to a charitable 
organization;
    (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.

                                   Table 2.--Estimated Annual Reporting Burden
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                            No. of      No. of Responses per     Total Annual     Hours per
     21 CFR Section       Respondents        Respondent           Responses       Response        Total Hours
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203.11                        12                 1                     12              .5              6
203.30(a)(1) and (b)      61,961                12                743,532              .06        44,612
203.30(a)(3), (a)(4),     61,961                12                743,532              .06        44,612
 and (c)
203.31(a)(1) and (b)     232,355               135             31,367,925              .04     1,254,717
203.31(a)(3), (a)(4),    232,355               135             31,367,925              .03       941,038
 and (c)
203.37(a)                     25                 1                     25             6.00           150
203.37(b)                    200                 1                    200             6.00         1,200
203.37(c)                     50                 1                     50             1.00            50

[[Page 71574]]

 
203.37(d)                  2,208                 1                  2,208              .08           177
203.38(a)                  2,208                 1                  2,208             3.00         6,624
203.39(g)                  3,221                 1                  3,221             2.00         6,442
203.50(a)                    125               100                 12,500              .08         1,000
Total                    ............  ......................  ...............  ............   2,300,628
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                               Table 3.--Estimated Annual Recordkeeping Burden\1\
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                            No. of      No. of Responses per     Total Annual     Hours per
     21 CFR Section       Respondents        Respondent           Responses       Response        Total Hours
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203.23(a) and (b)         31,676                 5                158,380              .25        39,595
203.23(c)                 31,676                 5                158,380              .08        12,670
203.30(a)(2) and           2,208               100                220,800              .50       110,400
 203.31(a)(2)
203.31(d)(1) and (d)(2)    2,208                 1                  2,208            40.00        88,320
203.31(d)(4)                 442                 1                    442            24.00        10,608
203.31(e)                  2,208                 1                  2,208             1.00         2,208
203.34                     2,208                 1                  2,208            40.00        88,320
203.37(a)                     25                 1                     25            18.00           450
203.37(b)                    200                 1                    200            18.00         3,600
203.38(b)                  2,208            14,543             32,111,457              .02       642,229
203.39(d)                     65                 1                     65             1.00            65
203.39(e)                  3,221                 1                  3,221              .50         1,610
203.39(f)                  3,221                 1                  3,221             8.00        25,768
203.39(g)                  3,221                 1                  3,221             8.00        25,768
203.50(a)                    125               100                 12,500              .17         2,125
203.50(b)                    125               100                 12,500              .50         6,250
203.50(d)                    691                 1                    691             2.00         1,382
Total                    ............  ......................  ...............  ............   1,061,368
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\1\ There are no operating and maintenance costs or capital costs associated with this collection of
  information.


    Dated: November 21, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30404 Filed 11-29-02; 8:45 am]
BILLING CODE 4160-01-S