Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements, 33717-33718 [2021-13597]

Download as PDF Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0525] 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. The Food and Drug Administration (FDA, we, or Agency) 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: Submit written comments (including recommendations) on the collection of information by July 26, 2021. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 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 SUMMARY: 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; Administrative Procedures, Policies, and Requirements—21 CFR Part 203 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) and the Prescription Drug Amendments of 1992. The Federal Food, Drug, and Cosmetic Act, as amended by the PDMA, establishes requirements for the following: • Reimportation of prescription drugs. • The sale, purchase, or trade of or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or health care entities or donated to charitable organizations. • The distribution of prescription drug samples by mail, common carrier, or another means of distribution. • Applications for reimportation to provide emergency medical care. • An appeal from an adverse decision by the district office. • Drug sample storage and handling. • Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping. • Donation of drug samples to charitable institutions. The PDMA was enacted, in part, because insufficient safeguards existed over the drug distribution system to prevent the introduction and retail sale 33717 of substandard, ineffective, or counterfeit drugs. The PDMA is 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. The applicable regulations in part 203 include reporting and recordkeeping requirements 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; and (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. In the Federal Register of March 12, 2021 (86 FR 14128), we published a 60day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondent Number of respondents 21 CFR section; activity Total annual responses Average burden per response Total hours 203.11; reimportation applications .... 203.37(a); falsification of records ..... 203.37(b); loss or theft of samples ... 203.37(c); conviction of representatives. 203.37(d); contact person ................. 1 140 140 1 1 21.4 178.57 1 1 3,000 25,000 1 0.5 (30 minutes) ............................... 0.25 (15 minutes) ............................. 0.25 (15 minutes) ............................. 1 ....................................................... 21 750 6,250 1 20 1 20 0.25 (15 minutes) ............................. 5 Total ........................................... ........................ ........................ 28,022 ........................................................... 7,007 1 There are no capital costs or operating and maintenance costs associated with this collection of information. to the nearest whole number. 2 Rounded VerDate Sep<11>2014 18:38 Jun 24, 2021 Jkt 253001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\25JNN1.SGM 25JNN1 33718 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of records per recordkeeper 2 Number of recordkeepers 21 CFR section; activity Total annual records Average burden per recordkeeping Total hours Subpart C: Sales restrictions 203.23(a) and (b); returns ............. 2,200 71.9909 158,380 0.25 (15 minutes) .......................... 39,595 203.23(c); documentation of storage of returns. 2,200 71.9909 158,380 0.08 (∼6 minutes) .......................... 12,670 Subpart D: Samples 203.30–203.39; documentation regarding sample distributions. 140 202 28,280 ∼.07–.08 (∼4–5 minutes) ............... 2,121 Total ........................................ .......................... .......................... 345,040 ........................................................ 54,386 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Rounded to the nearest whole number. Based on a review of Agency data, we assume 2,200 respondents may incur burden resulting from the information collection activity associated with the requirements in § 203.23(a) through (c). A total of 140 pharmaceutical companies have submitted information to the Agency on drug sample distribution under part 203. Those same respondents also have recordkeeping requirements under part 203. Our estimate of the burden of the average burden per recordkeeping reflects a cumulative average to cover all applicable requirements. Since our last request for OMB approval, we have adjusted our estimate of the overall burden downward to reflect a decrease of 2,567,713 hours and 64,432,232 records annually. We attribute this adjustment to a more accurate reflection of the number of respondents to the information collection and clarification that burden attributable to requirements of the Drug Quality and Security Act are not included in this information collection. [FR Doc. 2021–13597 Filed 6–24–21; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2021–N–0492] Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications Food and Drug Administration, HHS. ACTION: Approval is withdrawn as of July 26, 2021. DATES: FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: drug products were no longer marketed and requested that the approval of the applications be withdrawn. Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the SUMMARY: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Application No. Drug Applicant ANDA 062142 ...... Doxycycline Hyclate Capsules, Equivalent to (EQ) 50 milligrams (mg) base and EQ 200 mg base. ANDA 062497 ...... Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100 mg base. Cephalexin Capsules, EQ 250 mg base and EQ 500 mg base. Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008. Watson Laboratories, Inc. Do. IVAX Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. Do. Watson Laboratories, Inc. Do. Do. Do. ANDA 065152 ...... lotter on DSK11XQN23PROD with NOTICES1 Dated: June 21, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. ANDA 070550 ...... ANDA 070551 ...... ANDA 070943 ...... Propranolol Hydrochloride (HCl) Tablets, 40 mg .................... Propranolol HCl Tablets, 80 mg .............................................. Oxazepam Capsules, 10 mg ................................................... ANDA ANDA ANDA ANDA ANDA Oxazepam Capsules, 30 mg ................................................... Temazepam Capsules, 15 mg ................................................ Temazepam Capsules, 30 mg ................................................ Oxazepam Capsules, 10 mg ................................................... Baclofen Tablets, 10 mg ......................................................... 070945 071446 071447 072952 073092 VerDate Sep<11>2014 ...... ...... ...... ...... ...... 18:38 Jun 24, 2021 Jkt 253001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33717-33718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13597]



[[Page 33717]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0525]


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, we, or Agency) 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: Submit written comments (including recommendations) on the 
collection of information by July 26, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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, 
[email protected].

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; Administrative Procedures, Policies, and 
Requirements--21 CFR Part 203

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) and the Prescription Drug Amendments of 1992. The 
Federal Food, Drug, and Cosmetic Act, as amended by the PDMA, 
establishes requirements for the following:
     Reimportation of prescription drugs.
     The sale, purchase, or trade of or the offer to sell, 
purchase, or trade, prescription drugs that were purchased by hospitals 
or health care entities or donated to charitable organizations.
     The distribution of prescription drug samples by mail, 
common carrier, or another means of distribution.
     Applications for reimportation to provide emergency 
medical care.
     An appeal from an adverse decision by the district office.
     Drug sample storage and handling.
     Fulfillment houses, shipping and mailing services, 
comarketing agreements, and third-party recordkeeping.
     Donation of drug samples to charitable institutions.
    The PDMA was enacted, in part, because insufficient safeguards 
existed over the drug distribution system to prevent the introduction 
and retail sale of substandard, ineffective, or counterfeit drugs. The 
PDMA is 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.
    The applicable regulations in part 203 include reporting and 
recordkeeping requirements 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; and (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.
    In the Federal Register of March 12, 2021 (86 FR 14128), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   21 CFR section; activity        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
203.11; reimportation                        1               1               1  0.5 (30 minutes)           \2\ 1
 applications.
203.37(a); falsification of                140            21.4           3,000  0.25 (15                     750
 records.                                                                        minutes).
203.37(b); loss or theft of                140          178.57          25,000  0.25 (15                   6,250
 samples.                                                                        minutes).
203.37(c); conviction of                     1               1               1  1...............               1
 representatives.
203.37(d); contact person.....              20               1              20  0.25 (15                       5
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............          28,022  ................           7,007
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Rounded to the nearest whole number.


[[Page 33718]]


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
                                 Number of       records per      Total annual    Average burden
  21 CFR section; activity     recordkeepers     recordkeeper       records            per          Total hours
                                                     \2\                          recordkeeping
----------------------------------------------------------------------------------------------------------------
                                          Subpart C: Sales restrictions
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b); returns..            2,200          71.9909          158,380  0.25 (15                 39,595
                                                                                  minutes).
----------------------------------------------------------------------------------------------------------------
203.23(c); documentation of             2,200          71.9909          158,380  0.08 (~6                 12,670
 storage of returns.                                                              minutes).
----------------------------------------------------------------------------------------------------------------
                                               Subpart D: Samples
----------------------------------------------------------------------------------------------------------------
203.30-203.39; documentation              140              202           28,280  ~.07-.08 (~4-5            2,121
 regarding sample                                                                 minutes).
 distributions.
                             -----------------------------------------------------------------------------------
    Total...................  ...............  ...............          345,040  ...............          54,386
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Rounded to the nearest whole number.

    Based on a review of Agency data, we assume 2,200 respondents may 
incur burden resulting from the information collection activity 
associated with the requirements in Sec.  203.23(a) through (c). A 
total of 140 pharmaceutical companies have submitted information to the 
Agency on drug sample distribution under part 203. Those same 
respondents also have recordkeeping requirements under part 203. Our 
estimate of the burden of the average burden per recordkeeping reflects 
a cumulative average to cover all applicable requirements. Since our 
last request for OMB approval, we have adjusted our estimate of the 
overall burden downward to reflect a decrease of 2,567,713 hours and 
64,432,232 records annually. We attribute this adjustment to a more 
accurate reflection of the number of respondents to the information 
collection and clarification that burden attributable to requirements 
of the Drug Quality and Security Act are not included in this 
information collection.

    Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13597 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P
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