[Federal Register Volume 68, Number 93 (Wednesday, May 14, 2003)]
[Notices]
[Pages 25894-25897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0486]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Prescription Drug Marketing Act of 1987; 
Administrative Procedures, Policies, and Requirements

AGENCY: Food and Drug Administration, HHS.

[[Page 25895]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the information collection provisions by 
June 13, 2003.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that written comments be electronically mailed 
to [email protected] or faxed to the Office of Information and 
Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA, 
FAX: 202-395-6974.

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

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 Act of 1987; Administrative Procedures, 
Policies, and Requirements--21 CFR Part 3 (OMB Control Number 0910-
0435)--Extension

    The Food and Drug Administration (FDA) is requesting OMB approval 
under the Paperwork Reduction Act (44 U.S.C. 3507) for the reporting 
and recordkeeping requirements contained in the regulations 
implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Public 
Law 100-293). 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 
being 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 
that 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 U.S. goods returned causing a health and safety 
risk to U.S. 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 U.S. manufacturers 
and had 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 Requirements
------------------------------------------------------------------------
                                         Reporting and Recordkeeping
           21 CFR Section                        Requirements
------------------------------------------------------------------------
203.11                               Applications for re-importation to
                                      provide emergency medical care.
203.30(a)(1) and (b)                 Drug sample requests for drug
                                      samples distributed by mail or
                                      common carrier.
203.30(a)(3), (a)(4), and (c)        Drug sample receipts for drug
                                      samples distributed by mail or
                                      common carrier.
203.31(a)(1) and (b)                 Drug sample requests for drug
                                      samples distributed by means other
                                      than the mail or a common carrier.
203.31(a)(3), (a)(4), and (c)        Drug sample receipts for 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 memorandom for returned
                                      drugs.
203.23(c)                            Documentation of proper storage,
                                      handling, and shipping conditions
                                      of returned drugs.
203.30(a)(2) and 203.31(a)(2)        Verification that a practitioner
                                      requesting a drug sample is
                                      licensed or authorized to
                                      prescribe the product.
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.

[[Page 25896]]

 
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.
    In the Federal Register of December 2, 2002 (67 FR 71572), FDA 
requested comments on the proposed collection of information. FDA 
received one comment requesting that it be deemed an ``other health 
care entity'' and be permitted to receive and dispense samples to its 
patients. This comment does not pertain to the information collection 
estimates in the December 2, 2002, notice, and has been forwarded to 
the appropriate office in FDA that reviews these types of requests.

                                                       Table 2.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      No. of        No. of Responses     Total Annual        Hours per
                21 CFR Section                     Respondents       per Respondent       Responses           Response               Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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), and (c)                              61,961                 12            743,532                .06                        44,612
203.31(a)(1) and (b)                                      232,355                135         31,367,925                .04                     1,254,717
203.31(a)(3), (a)(4) and (c)                              232,355                135         31,367,925                .03                       941,038
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
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
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Total Reporting Burden Hours                                                                                                                   2,300,628
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                                                   Table 3.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      No. of        Annual Frequency     Total Annual        Hours per
                21 CFR Section                    Recordkeepers    per Recordkeeping       Records          Recordkeeper             Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 203.31(a)(2)                               2,208                100            220,800                .50                       110,400
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

[[Page 25897]]

 
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 Recordkeeping Burden Hours                                                                                                               1,061,368
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 2, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11925 Filed 5-13-03; 8:45 am]
BILLING CODE 4160-01-S