83 FR 101 pgs. 24127-24128 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
Type: NOTICEVolume: 83Number: 101Pages: 24127 - 24128
Pages: 24127, 24128Docket number: [Docket No. FDA-2011-N-0279]
FR document: [FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0279]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information 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 collection of information by June 25, 2018.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0435. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
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
OMB Control Number 0910-0435-Extension
This information collection supports FDA regulations codified at part 203 (21 CFR part 203) implementing the Prescription Drug Marketing Act of 1987 (PDMA). The PDMA was intended to ensure safe and effective drug products and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold to consumers. The reporting and recordkeeping requirements found in the regulations 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 prescription 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 healthcare entities at the request of a licensed or authorized practitioner; (4) to require licensed or authorized practitioners to request prescription drug samples in writing; (5) to mandate storage, handling, and recordkeeping requirements for prescription drug samples; (6) to prohibit, with certain exceptions, the sale, purchase, or trade, or the offer to sell, purchase, or trade, of prescription drugs that were purchased by hospitals or other healthcare entities or that were donated or supplied at a reduced price to a charitable organization; and (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 14, 2017 (82 FR 58808), we published a notice soliciting public comment of the information collection. One caller responded to the notice asking about the impact the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality Security Act of 2013) has on the information collection. We note that the Agency is currently proposing to amend its regulations at part 203 to reflect changes resulting from enactment of the DSCSA (RIN 0910-AH56). While we expect these changes will result in a reduction of burden associated with the information collection, current regulations and associated information collection requirements remain in effect. Upon finalization of rulemaking, we will revise the information collection accordingly.
[top] We therefore estimate the burden for the information collection as follows:
| 21 CFR section/a ctivity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 203.11-Reimportation | 1 | 1 | 1 | 0.5 (30 minutes) | 1 |
| 203.30(a)(1) and (b)-Drug sample requests | 61,961 | 12 | 743,532 | 0.06 (4 minutes) | 44,612 |
| 203.30(a)(3), (a)(4), and (c)-Drug sample receipts | 61,961 | 12 | 743,532 | 0.06 (4 minutes) | 44,612 |
| 203.31(a)(1) and (b)-Drug sample requests | 232,355 | 135 | 31,367,925 | 0.04 (2.5 minutes) | 1,254,717 |
| 203.31(a)(3), (a)(4), and (c)-Drug sample receipts | 232,355 | 135 | 31,367,925 | 0.03 (2 minutes) | 941,038 |
| 203.37(a)-Falsification of records | 50 | 4 | 200 | 0.25 (15 minutes) | 50 |
| 203.37(b)-Loss or theft of samples | 50 | 40 | 2,000 | 0.25 (15 minutes) | 500 |
| 203.37(c)-Convictions | 1 | 1 | 1 | 1 | 1 |
| 203.37(d)-Contact person | 50 | 1 | 50 | 0.08 (5 minutes) | 4 |
| 203.39(g)-Reconciliation report | 1 | 1 | 1 | 1 | 1 |
| Total | 2,285,536 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 21 CFR Section/Activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 203.23(a) and (b)-Returned drugs | 31,676 | 5 | 158,380 | 0.25 (15 minutes) | 39,595 |
| 203.23(c)-Returned drugs documentation | 31,676 | 5 | 158,380 | 0.08 (5 minutes) | 12,670 |
| 203.30(a)(2) and 203.31(a)(2)-Practitioner verification | 2,208 | 100 | 220,800 | 0.5 (30 minutes) | 110,400 |
| 203.31(d)(1) and (2)-Inventory record and reconciliation report | 2,208 | 1 | 2,208 | 40 | 88,320 |
| 203.31(d)(4)-Investigation of discrepancies and losses | 442 | 1 | 442 | 24 | 10,608 |
| 203.31(e)-Representatives lists | 2,208 | 1 | 2,208 | 1 | 2,208 |
| 203.34-Administrative systems | 90 | 1 | 90 | 40 | 3,600 |
| 203.37(a)-Falsification of drug sample records | 50 | 4 | 200 | 6 | 1,200 |
| 203.37(b)-Loss or theft of drug samples | 50 | 40 | 2,000 | 6 | 12,000 |
| 203.39(d)-Destroyed or returned drug samples | 65 | 1 | 65 | 1 | 65 |
| 203.39(e)-Donated drug samples | 3,221 | 1 | 3,221 | 0.5 (30 minutes) | 1,611 |
| 203.39(f)-Distribution of donated drug samples | 3,221 | 1 | 3,221 | 8 | 25,768 |
| 203.39(g)-Drug samples donated to charitable institutions | 3,221 | 1 | 3,221 | 8 | 25,768 |
| 203.50(a)-Drug origin statement | 125 | 100 | 12,500 | 0.17 (10 minutes) | 2,125 |
| 203.50(b)-Drug origin statement retention | 125 | 100 | 12,500 | 0.5 (30 minutes) | 6,250 |
| 203.50(d)-Authorized distributors of record | 691 | 1 | 691 | 2 | 1,382 |
| Total | 343,570 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Based on a review of Agency data, we retain the currently approved burden estimate for the information collection, as reflected in tables 1 and 2 above.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]
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