[Federal Register: December 2, 2002 (Volume 67, Number 231)]
[Notices]
[Page 71572-71574]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de02-97]
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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
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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.
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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