83 FR 24127 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 101 (May 24, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 101 (May 24, 2018)
| Page Range | 24127-24128 | |
| FR Document | 2018-11113 |
[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)] [Notices] [Pages 24127-24128] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11113] ----------------------------------------------------------------------- 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. We therefore estimate the burden for the information collection as follows: [[Page 24128]] Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section/a ctivity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- 203.11--Reimportation.......... 1 1 1 0.5 (30 1 minutes). 203.30(a)(1) and (b)--Drug 61,961 12 743,532 0.06 (4 44,612 sample requests. minutes). 203.30(a)(3), (a)(4), and (c)-- 61,961 12 743,532 0.06 (4 44,612 Drug sample receipts. minutes). 203.31(a)(1) and (b)--Drug 232,355 135 31,367,925 0.04 (2.5 1,254,717 sample requests. minutes). 203.31(a)(3), (a)(4), and (c)-- 232,355 135 31,367,925 0.03 (2 941,038 Drug sample receipts. minutes). 203.37(a)--Falsification of 50 4 200 0.25 (15 50 records. minutes). 203.37(b)--Loss or theft of 50 40 2,000 0.25 (15 500 samples. minutes). 203.37(c)--Convictions......... 1 1 1 1.............. 1 203.37(d)--Contact person...... 50 1 50 0.08 (5 4 minutes). 203.39(g)--Reconciliation 1 1 1 1.............. 1 report. -------------------------------------------------------------------------------- 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\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR Section/Activity Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- 203.23(a) and (b)--Returned 31,676 5 158,380 0.25 (15 39,595 drugs. minutes). 203.23(c)--Returned drugs 31,676 5 158,380 0.08 (5 12,670 documentation. minutes). 203.30(a)(2) and 203.31(a)(2)-- 2,208 100 220,800 0.5 (30 110,400 Practitioner verification. minutes). 203.31(d)(1) and (2)--Inventory 2,208 1 2,208 40............. 88,320 record and reconciliation report. 203.31(d)(4)--Investigation of 442 1 442 24............. 10,608 discrepancies and losses. 203.31(e)--Representatives 2,208 1 2,208 1.............. 2,208 lists. 203.34--Administrative systems. 90 1 90 40............. 3,600 203.37(a)--Falsification of 50 4 200 6.............. 1,200 drug sample records. 203.37(b)--Loss or theft of 50 40 2,000 6.............. 12,000 drug samples. 203.39(d)--Destroyed or 65 1 65 1.............. 65 returned drug samples. 203.39(e)--Donated drug samples 3,221 1 3,221 0.5 (30 1,611 minutes). 203.39(f)--Distribution of 3,221 1 3,221 8.............. 25,768 donated drug samples. 203.39(g)--Drug samples donated 3,221 1 3,221 8.............. 25,768 to charitable institutions. 203.50(a)--Drug origin 125 100 12,500 0.17 (10 2,125 statement. minutes). 203.50(b)--Drug origin 125 100 12,500 0.5 (30 6,250 statement retention. minutes). 203.50(d)--Authorized 691 1 691 2.............. 1,382 distributors of record. -------------------------------------------------------------------------------- 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] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices 24127
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of responses Total annual
21 CFR section; activity burden per Total hours
respondents per responses response
respondent
507.7(e)(1); change labels on products with labels ..................... 1,526 4 6,104 1 ............................ 6,104
507.7(e)(2); change address on labeling (sales documents) for 1,329 1 1,329 1 ............................ 1,329
qualified facilities.
507.25(a)(2); animal food, including raw materials, other ingredi- 330 312 102,960 0.01 (36 seconds) 1,030
ents, and rework, is accurately identified.
507.28(b); holding and distribution of human food byproducts for 40,798 2 81,596 0.25 (15 minutes) 20,399
use as animal food.
Total ....................................................................................... .................... .................... .................... ............................... 29,687
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our OMB recommends that written prescription drug sample; (3) to limit
regulatory impact analysis in support of comments be faxed to the Office of the distribution of drug samples to
the final rule on Preventive Controls for Information and Regulatory Affairs, practitioners licensed or authorized to
Food for Animals, which published in OMB, Attn: FDA Desk Officer, Fax: 202– prescribe such drugs or to pharmacies of
the Federal Register of September 17, 395–7285, or emailed to oira_ hospitals or other healthcare entities at
2015 (80 FR 56170). Using Agency data submission@omb.eop.gov. All the request of a licensed or authorized
we estimated the number of animal food comments should be identified with the practitioner; (4) to require licensed or
facilities that we believe are subject to OMB control number 0910–0435. Also authorized practitioners to request
the regulations. We base our estimate of include the FDA docket number found prescription drug samples in writing; (5)
the time necessary for the individual in brackets in the heading of this to mandate storage, handling, and
reporting, recordkeeping, and third- document. recordkeeping requirements for
party disclosure activities on our FOR FURTHER INFORMATION CONTACT: prescription drug samples; (6) to
experience with similar information prohibit, with certain exceptions, the
Domini Bean, Office of Operations,
collections. sale, purchase, or trade, or the offer to
Food and Drug Administration, Three
Dated: May 18, 2018. White Flint North, 10A–12M, 11601 sell, purchase, or trade, of prescription
Leslie Kux, Landsdown St., North Bethesda, MD drugs that were purchased by hospitals
Associate Commissioner for Policy. 20852, 301–796–5733, PRAStaff@ or other healthcare entities or that were
[FR Doc. 2018–11114 Filed 5–23–18; 8:45 am] fda.hhs.gov. donated or supplied at a reduced price
to a charitable organization; and (7) to
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: In
require unauthorized wholesale
compliance with 44 U.S.C. 3507, FDA
distributors to provide, prior to the
has submitted the following proposed
DEPARTMENT OF HEALTH AND wholesale distribution of a prescription
collection of information to OMB for
HUMAN SERVICES drug to another wholesale distributor or
review and clearance.
retail pharmacy, a statement identifying
Food and Drug Administration Prescription Drug Marketing Act of each prior sale, purchase, or trade of the
[Docket No. FDA–2011–N–0279] 1987—Administrative Procedures, drug.
Policies, and Requirements In the Federal Register of December
Agency Information Collection OMB Control Number 0910–0435— 14, 2017 (82 FR 58808), we published a
Activities; Submission for Office of Extension notice soliciting public comment of the
Management and Budget Review; information collection. One caller
Comment Request; Prescription Drug This information collection supports
FDA regulations codified at part 203 (21 responded to the notice asking about the
Marketing; Administrative Procedures, impact the Drug Supply Chain Security
Policies, and Requirements CFR part 203) implementing the
Prescription Drug Marketing Act of 1987 Act (DSCSA) (Title II of the Drug
AGENCY: Food and Drug Administration, (PDMA). The PDMA was intended to Quality Security Act of 2013) has on the
HHS. ensure safe and effective drug products information collection. We note that the
ACTION: Notice. and to avoid an unacceptable risk that Agency is currently proposing to amend
counterfeit, adulterated, misbranded, its regulations at part 203 to reflect
SUMMARY: The Food and Drug subpotent, or expired drugs are sold to changes resulting from enactment of the
Administration (FDA) is announcing consumers. The reporting and DSCSA (RIN 0910–AH56). While we
that a proposed collection of recordkeeping requirements found in expect these changes will result in a
information has been submitted to the the regulations are intended to help reduction of burden associated with the
Office of Management and Budget achieve the following goals: (1) To ban information collection, current
(OMB) for review and clearance under regulations and associated information
sradovich on DSK3GMQ082PROD with NOTICES
the reimportation of prescription drugs
the Paperwork Reduction Act of 1995. produced in the United States, except collection requirements remain in effect.
DATES: Fax written comments on the when reimported by the manufacturer Upon finalization of rulemaking, we
collection of information by June 25, or under FDA authorization for will revise the information collection
2018. emergency medical care; (2) to ban the accordingly.
ADDRESSES: To ensure that comments on sale, purchase, or trade, or the offer to We therefore estimate the burden for
the information collection are received, sell, purchase, or trade, of any the information collection as follows:
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![24128 Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
21 CFR section/activity responses per Total hours
respondents responses per response
respondent
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
Number of
Number of Total annual Average burden
21 CFR Section/Activity records per Total hours
recordkeepers records per recordkeeping
recordkeeper
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 reconcili- 2,208 1 2,208 40 ........................ 88,320
ation report.
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 institu- 3,221 1 3,221 8 .......................... 25,768
tions.
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 ACTION: Notice of availability. Electronic Submissions
retain the currently approved burden
estimate for the information collection, SUMMARY: The Food and Drug Submit electronic comments in the
as reflected in tables 1 and 2 above. Administration (FDA or Agency) is following way:
Dated: May 18, 2018. announcing the availability of a • Federal eRulemaking Portal:
Leslie Kux, guidance for industry entitled ‘‘Anthrax: https://www.regulations.gov. Follow the
Associate Commissioner for Policy. Developing Drugs for Prophylaxis of instructions for submitting comments.
Inhalational Anthrax.’’ The purpose of Comments submitted electronically,
[FR Doc. 2018–11113 Filed 5–23–18; 8:45 am]
this guidance is to assist sponsors in the including attachments, to https://
BILLING CODE 4164–01–P
development of new drugs for the www.regulations.gov will be posted to
prophylaxis of inhalational anthrax. the docket unchanged. Because your
comment will be made public, you are
DEPARTMENT OF HEALTH AND This guidance finalizes the draft
HUMAN SERVICES solely responsible for ensuring that your
guidance of the same name issued on
comment does not include any
February 16, 2016.
Food and Drug Administration confidential information that you or a
third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
DATES: The announcement of the
[Docket No. FDA–2016–D–0412] such as medical information, your or
guidance is published in the Federal
Register on May 24, 2018. anyone else’s Social Security number, or
Anthrax: Developing Drugs for
confidential business information, such
Prophylaxis of Inhalational Anthrax; ADDRESSES: You may submit either as a manufacturing process. Please note
Guidance for Industry; Availability electronic or written comments on that if you include your name, contact
AGENCY: Food and Drug Administration, Agency guidances at any time as information, or other information that
HHS. follows: identifies you in the body of your
VerDate Sep<11>2014 18:10 May 23, 2018 Jkt 244001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\24MYN1.SGM 24MYN1](https://thefederalregister.org/doc/83_FR_24228/page/2.svg)
Document Created: 2018-05-24 00:05:51
Document Modified: 2018-05-24 00:05:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by June 25, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 24127 |
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