Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83095 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section/activity No. of recordkeepers 

No. of records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

511.1(b)(7); maintain records of the investigation, including 

records of the receipt and disposition of each shipment or 

delivery of the investigational new animal drug ..................... 279 5.94 1,657 3.5 5,800 

511.1(b)(8)(i); maintain records of all reports received by a 

sponsor from investigators ..................................................... 279 5.94 1,657 3.5 5,800 

Total ........................................................................................... ........................ ........................ 5,247 ........................ 13,533 

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

The estimate of the time required for 

reporting requirements, record 

preparation, and maintenance for this 

collection of information is based on our 

informal communication with industry. 

Based on the number of sponsors 

subject to animal drug user fees, we 

estimate that there are 279 respondents. 

We use this estimate consistently 

throughout the table and calculate the 

‘‘number of responses per respondent’’ 

by dividing the total annual responses 

by number of respondents. We note an 

apparent difference in the estimated 

number of respondents from the 

previous renewal issued in 2018. There 

was an error in calculating the number 

of sponsors subject to animal drug user 

fees in the 2018 renewal. When 

calculating the number of 

recordkeepers, we inadvertently used 

the number of sponsors that paid user 

fees (i.e., those that did not qualify for 

user fee waivers) as opposed to the total 

number of sponsors subject to animal 

drug user fees. Both fee-paying and nonfee-paying sponsors are respondents 

with respect to this information 

collection. 

Additional information needed to 

make a final calculation of the total 

burden hours (i.e., the number of 

respondents, the number of 

recordkeepers, the number of NCIEs 

received, etc.) is derived from our 

records. There is a small increase in the 

total burden hours which we attribute to 

an increase in the number of annual 

responses and records. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28068 Filed 12–18–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–P–1650] 

Determination That DOBUTREX 

(Dobutamine Hydrochloride), 

Equivalent 12.5 Milligram Base/ 

Milliliter, Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that DOBUTREX 

(dobutamine hydrochloride), equivalent 

(eq) 12.5 milligram (mg) base/milliliter 

(mL), was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Tierney, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6213, 

Silver Spring, MD 20993–0002, 301– 

796–9120, Jessica.Tierney@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

DOBUTREX (dobutamine 

hydrochloride), eq 12.5 mg base/mL, is 

the subject of NDA 017820, held by Eli 

Lilly and Co., and initially approved on 

July 18, 1978. DOBUTREX is indicated 

for when parenteral therapy is necessary 

for inotropic support in the short-term 

treatment of adults with cardiac 

decompensation due to depressed 

contractility resulting either from 

organic heart disease or from cardiac 

surgical procedures. DOBUTREX 

(dobutamine hydrochloride), eq 12.5 mg 

base/mL, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Cardinal Health submitted a citizen 

petition dated July 9, 2020 (Docket No. 

FDA–2020–P–1650), under 21 CFR 

10.30, requesting that the Agency 

determine whether DOBUTREX 

83096 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

(dobutamine hydrochloride), eq 12.5 mg 

base/mL, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that DOBUTREX (dobutamine 

hydrochloride), eq 12.5 mg base/mL, 

was not withdrawn for reasons of safety 

or effectiveness. The petitioner has 

identified no data or other information 

suggesting that this drug product was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

DOBUTREX (dobutamine 

hydrochloride), eq 12.5 mg base/mL, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that this drug 

product was not withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list DOBUTREX 

(dobutamine hydrochloride), eq 12.5 mg 

base/mL, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. FDA 

will not begin procedures to withdraw 

approval of approved ANDAs that refer 

to this drug product. Additional ANDAs 

for this drug product may also be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28080 Filed 12–18–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0417] 

Request for Nominations of Voting 

Members on a Public Advisory 

Committee; National Mammography 

Quality Assurance Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the National Mammography 

Quality Assurance Advisory Committee 

in the Center for Devices and 

Radiological Health. Nominations will 

be accepted for upcoming vacancies 

effective February 1, 2021, with this 

notice. FDA seeks to include the views 

of women and men, members of all 

racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before February 19, 2021, will be given 

first consideration for membership on 

the National Mammography Quality 

Assurance Advisory Committee. 

Nominations received after February 19, 

2021, will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Nomination Portal at https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member on an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions for 

membership: Aden Asefa, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5214, 

Silver Spring, MD 20993, 301–796– 

0400, Aden.Asefa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members to fill upcoming vacancies on 

the National Mammography Quality 

Assurance Advisory Committee. 

I. General Description of the Committee 

Duties 

The National Mammography Quality 

Assurance Advisory Committee advises 

the Commissioner of Food and Drugs 

(the Commissioner) or designee on: (1) 

Developing appropriate quality 

standards and regulations for 

mammography facilities; (2) developing 

appropriate standards and regulations 

for bodies accrediting mammography 

facilities under this program; (3) 

developing regulations with respect to 

sanctions; (4) developing procedures for 

monitoring compliance with standards; 

(5) establishing a mechanism to 

investigate consumer complaints; (6) 

reporting new developments concerning 

breast imaging that should be 

considered in the oversight of 

mammography facilities; (7) 

determining whether there exists a 

shortage of mammography facilities in 

rural and health professional shortage 

areas and determining the effects of 

personnel on access to the services of 

such facilities in such areas; (8) 

determining whether there will exist a 

sufficient number of medical physicists 

after October 1, 1999; and (9) 

determining the costs and benefits of 

compliance with these requirements. 

II. Criteria for Voting Members 

The committee consists of a core of 15 

members, including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

physicians, practitioners, and other 

health professionals, whose clinical 

practice, research specialization, or 

professional expertise includes a 

significant focus on mammography. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. Members will be invited to 

serve for terms of up to 4 years. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified persons for 

membership on the advisory committee. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address, telephone number, 

and email address if available, and a 

signed copy of the Acknowledgement 

and Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES). Nominations must specify 

the advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the