Source: https://www.federalregister.gov/documents/2009/09/01/E9-21026/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2018-09-22 05:14:45
Document Index: 550883426

Matched Legal Cases: ['art 203', '§\u2009203', '§\u2009203', '§\u2009203', '§\u2009203', '§\u2009203']

Federal Register :: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987
Fax written comments on the collection of information by October 1, 2009.
74 FR 45216
45216-45219 (4 pages)
E9-21026
Prescription Drug Marketing Act of 1987; 21 CFR Part 203 (OMB Control Number 0910-0435)—Extension
https://www.federalregister.gov/d/E9-21026 https://www.federalregister.gov/d/E9-21026
Elizabeth Berbakos, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3792, Elizabeth.Berbakos@fda.hhs.gov.
FDA is requesting OMB approval under the Paperwork Reduction Act (44 U.S.C. 3501-3520) 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 that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold.
FDA is requesting OMB approval for the following reporting and recordkeeping requirements:Start Printed Page 45217
21 CFR 203.30(a)(3), (a)(4), and (c) Drug sample receipts (receipts for drug samples distributed by mail or common carrier).
21 CFR 203.31(a)(3), (a)(4), and (c) Drug sample receipts (drug samples distributed by means other than the mail or a common carrier).
(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;
(4) To require licensed or authorized practitioners to request prescription drug samples in writing;Start Printed Page 45218
In the Federal Register of March 24, 2009 (74 FR 12365), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment.
Comment Summary: The comment pertained to the recordkeeping requirements in § 203.50(a) and (b) (21 CFR 203.50(a) and (b)).
The comment concluded that FDA's estimate of “0” recordkeeping hours for these regulations in table 2 of the March 24, 2009, notice was in error. In summary, the comment contended: (1) Pedigrees must be passed by nonauthorized distributors of record prior to each wholesale distribution; (2) all wholesale distributors that provide or receive pedigrees after December 1, 2006, must retain copies of the pedigrees for 3 years; and (3) those records must include names and addresses of all parties to the transaction and the date of the transactions.
The comment offered no estimates for the recordkeeping provisions in § 203.50(a) and (b). The comment explained that it is unable to suggest estimates for the burden hours because most of its members “have likely received a designation of ‘ADR’ status by most drug manufacturers for most of the prescription drug products that they purchase, and they provide pedigrees only on a limited basis.” Thus, the comment said, there are a large number of distributors that are not members of its organization but are subject to the pedigree requirements and, therefore, the burden hours that its members alone accrue would not be reflective of the entire population of distributors that are affected, and would likely be a minority of the total burden hours that all distributors experience.
FDA Response: FDA appreciates the comment and, as requested, we plan to conduct research to obtain estimates for the burden hours that may be currently incurred by distributors to comply with the recordkeeping provisions in § 203.50. We are requesting that interested persons submit to the docket (identified in brackets in the heading of this document) data on the burden hours currently incurred by distributors to comply with the recordkeeping provisions in § 203.50. In response to the comment, we are also adding to the Estimated Annual Recordkeeping Burden (table 4 of this document) recordkeeping estimates for § 203.50. We used these estimates in previous Federal Register notices based on information we received at that time, and no comments were received on these burden hours. If our research results in new data that differs from these estimates, we will amend the approval for OMB control number 0910-0435 to include revised estimates for these provisions.
Table 3.—Estimated Annual Reporting Burden1
Total Hours2
203.11 1 1 1 .5 1
203.30(a)(3), (a)(4), and (c) 61,961 12 743,532 .06 44,612
203.31(a)(3), (a)(4), and (c) 232,355 135 31,367,925 .03 941,038
Total Reporting Burden Hours 2,285,536
2 Estimates are not exact due to rounding.
Start Printed Page 45219
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 2.0 1,382
Total Recordkeeping Burden Hours 332,769
[FR Doc. E9-21026 Filed 8-31-09; 8:45 am]