[Federal Register: May 14, 2003 (Volume 68, Number 93)]
[Notices]
[Page 25894-25897]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my03-64]
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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 sshapiro@omb.eop.gov 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
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Reporting and Recordkeeping
21 CFR Section Requirements
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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.
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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.
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
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No. of No. of Responses Total Annual Hours per
21 CFR Section Respondents per 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), 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\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper 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 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
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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