Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 33717 

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, 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 

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

21 CFR section; activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Average burden 

per response Total hours 

203.11; reimportation applications .... 1 1 1 0.5 (30 minutes) ............................... 2 1 

203.37(a); falsification of records ..... 140 21.4 3,000 0.25 (15 minutes) ............................. 750 

203.37(b); loss or theft of samples ... 140 178.57 25,000 0.25 (15 minutes) ............................. 6,250 

203.37(c); conviction of representatives.1 1 1 1 ....................................................... 1 

203.37(d); contact person ................. 20 1 20 0.25 (15 minutes) ............................. 5 

Total ........................................... ........................ ........................ 28,022 ........................................................... 7,007 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Rounded to the nearest whole number. 


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33718 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 2

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 

1There 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. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0492] 

Watson Laboratories, Inc. et al.; 

Withdrawal of Approval of 36 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of July 

26, 2021. 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: 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. 

Application 

No. Drug Applicant 

ANDA 062142 ...... Doxycycline Hyclate Capsules, Equivalent to (EQ) 50 milligrams (mg) base and EQ 200 mg base.Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 062497 ...... Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100 

mg base.

Teva Pharmaceuticals USA, Inc. 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 065152 ...... Cephalexin Capsules, EQ 250 mg base and EQ 500 mg 

base.

Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. 

agent, Carlsbad Technology, Inc./Simon Law, 5922 

Farnsworth Ct., Suite 101, Carlsbad, CA 92008. 

ANDA 070550 ...... Propranolol Hydrochloride (HCl) Tablets, 40 mg .................... Watson Laboratories, Inc. 

ANDA 070551 ...... Propranolol HCl Tablets, 80 mg .............................................. Do. 

ANDA 070943 ...... Oxazepam Capsules, 10 mg ................................................... IVAX Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 070945 ...... Oxazepam Capsules, 30 mg ................................................... Do. 

ANDA 071446 ...... Temazepam Capsules, 15 mg ................................................ Watson Laboratories, Inc. 

ANDA 071447 ...... Temazepam Capsules, 30 mg ................................................ Do. 

ANDA 072952 ...... Oxazepam Capsules, 10 mg ................................................... Do. 

ANDA 073092 ...... Baclofen Tablets, 10 mg ......................................................... Do. 


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