2018-11113. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
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Start Preamble
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.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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.
We therefore estimate the burden for the information collection as follows:Start Printed Page 24128
Table 1—Estimated Annual Reporting Burden 1
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. Table 2—Estimated Annual Recordkeeping Burden 1
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.
Start SignatureDated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Published:
- 05/24/2018
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 2018-11113
- Dates:
- Fax written comments on the collection of information by June 25, 2018.
- Pages:
- 24127-24128 (2 pages)
- Docket Numbers:
- Docket No. FDA-2011-N-0279
- PDF File:
- 2018-11113.Pdf
- Supporting Documents:
- » Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- » Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
- » Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
- » Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reports and Records Under Prescription Drug Marketing Act of 1987