83092 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

TABLE 1—CERTIFICATES AND USES

Type of certificate Use 

‘‘Supplementary Information Certificate to Foreign Government Requests‘‘.

‘‘Exporter’s Certification Statement Certificate to Foreign Government‘‘. 

‘‘Exporter’s Certification Statement Certificate to Foreign Government 

(For Human Tissue Intended for Transplantation)‘‘..

For the export of products legally marketed in the United States. 

‘‘Supplementary Information Certificate of Exportability Requests‘‘ ........

Exporter’s Certification Statement Certificate of Exportability‘‘. ...............

For the export of products not approved for marketing in the United 

States (unapproved products) that meet the requirements of sections 

801(e) or 802 of the FD&C Act. 

‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘ ...

‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical 

Product‘‘.

Conforms to the format established by the World Health Organization 

and is intended for use by the importing country when the product in 

question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or 

reviewing a license. 

‘‘Supplementary Information Non-Clinical Research Use Only Certificate‘‘.

‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)‘‘

For the export of a non-clinical research use only product, material, or 

component that is not intended for human use and which may be 

marketed in, and legally exported from the United States under the 

FD&C Act. 

Appropriate centers within FDA 

review product information submitted 

by firms in support of the firms’ 

certificate requests. We rely on 

respondents to certify their compliance 

with all applicable requirements of the 

FD&C Act both at the time the 

certification request is submitted to FDA 

and at the time the certification is 

submitted to the respective foreign 

government. Information regarding 

FDA’s Export Certificates may be found 

on our website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/fda-exportcertificates. 

On September 16, 2020, we submitted 

an information collection request to the 

Office of Management and Budget 

(OMB) to revise certain data elements as 

may be applicable under the 

Coronavirus Aid, Relief, and Economic 

Security Act (CARES Act). Because 

Section 3856 of the CARES Act 

contained immediately effective 

provisions obligating FDA to review and 

process certification requests, we 

requested emergency processing by 

OMB under 5 CFR 1320.13 for the 

respective information collection. Our 

information collection request was 

granted by OMB on September 29, 2020. 

Therefore, in accordance with 5 CFR 

1320.8(d)(1), we invite comment on the 

burden we attribute to the information 

collection, which we estimate as 

follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN1

FDA center Number of 

Respondents 

Number of 

Responses 

per Respondent 

Total Anual 

responses 

Average burden per 

response 

Total hours 

Center for Biologics Evaluation and Research .................... 2,651 1 2,651 1 2,651 

Center for Devices and Radiological Health ....................... 11,175 1 11,175 2 22,350 

Center for Drug Evaluation and Research .......................... 3,680 1 3,680 1 3,680 

Center for Veterinary Medicine ............................................ 1,925 1 1,925 1 1,925 

Total .............................................................................. ........................ ........................ ........................ ........................ 30,606 

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

Based on our current evaluation of the 

information collection, we have made 

no adjustments since our last request for 

OMB review and approval. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28064 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–N–2217] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; New Animal Drugs 

for Investigational Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the reporting and 

recordkeeping requirements of our 

regulations concerning new animal 

drugs for investigational use. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 19, 2021. 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 83093 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 19, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 19, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–N–2217 for ‘‘New Animal Drugs 

for Investigational Use.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

New Animal Drugs for Investigational 

Use—21 CFR Part 511 

OMB Control Number 0910–0117— 

Extension 

FDA has the authority under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to approve new animal 

drugs. A new animal drug application 

(NADA) cannot be approved until, 

among other things, the new animal 

drug has been demonstrated to be safe 

and effective for its intended use(s). In 

order to properly test a new animal drug 

for an intended use, appropriate 

scientific investigations must be 

conducted. Under specific 

circumstances, section 512(j) of the 

FD&C Act (21 U.S.C. 360b(j)) permits 

the use of an investigational new animal 

drug to generate data to support a 

NADA approval. Section 512(j) of the 

FD&C Act authorizes us to issue 

regulations relating to the 

investigational use of new animal drugs. 

Our regulations in part 511 (21 CFR 

part 511) set forth the conditions for 

investigational use of new animal drugs 

and require reporting and 

recordkeeping. The information 

collected is necessary to protect the 

83094 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices 

public health. We use the information to 

determine that investigational animal 

drugs are distributed only to qualified 

investigators, adequate drug 

accountability records are maintained, 

and edible food products from treated 

food-producing animals are safe for 

human consumption. We also use the 

information collected to monitor the 

validity of the studies submitted to us 

to support new animal drug approval. 

Reporting: Our regulations require 

that certain information be submitted to 

us in a ‘‘Notice of Claimed 

Investigational Exemption for a New 

Animal Drug’’ (NCIE) to qualify for the 

exemption and to control shipment of 

the new animal drug and prevent 

potential abuse. The NCIE must contain, 

among other things, the following 

specific information: (1) Identity of the 

new animal drug, (2) labeling, (3) 

statement of compliance of any nonclinical laboratory studies with good 

laboratory practices, (4) name and 

address of each clinical investigator, (5) 

the approximate number of animals to 

be treated or amount of new animal 

drug(s) to be shipped, and (6) 

information regarding the use of edible 

tissues from investigational animals 

(§ 511.1(b)(4) (21 CFR 511.1(b)(4))). If 

the new animal drug is to be used in 

food-producing animals (e.g., cattle, 

swine, chickens, fish, etc.), certain data 

must be submitted to us to obtain 

authorization for the use of edible food 

products from treated food-producing 

animals (§ 511.1(b)(5)). We require 

sponsors upon request to submit 

information with respect to the 

investigation to determine whether 

there are grounds for terminating the 

exemption (§ 511.1(b)(6)). We require 

sponsors to report findings that may 

suggest significant hazards pertinent to 

the safety of the new animal drug 

(§ 511.1(b)(8)(ii)). We also require 

reporting by importers of investigational 

new animal drugs for clinical 

investigational use in animals 

(§ 511.1(b)(9)). The information 

provided by the sponsor in the NCIE is 

needed to help ensure that the proposed 

investigational use of the new animal 

drug is safe and that any edible food 

will not be distributed without proper 

authorization from FDA. Information 

contained in an NCIE submission is 

monitored under our Bioresearch 

Monitoring Program. This program 

permits us to monitor the validity of the 

studies and to help ensure the proper 

use of the drugs is maintained by the 

investigators. 

Recordkeeping: If the new animal 

drug is only for tests in vitro or in 

laboratory research animals, the person 

distributing the new animal drug must 

maintain records showing the name and 

post office address of the expert or 

expert organization to whom it is 

shipped and the date, quantity, and 

batch or code mark of each shipment 

and delivery for a period of 2 years after 

such shipment or delivery (§ 511.1(a)(3) 

and (b)(3)). We require complete records 

of the investigation, including records of 

the receipt and disposition of each 

shipment or delivery of the 

investigational new animal drug 

(§ 511.1(b)(7)). We also require records 

of all reports received by a sponsor from 

investigators to be retained for 2 years 

after the termination of an 

investigational exemption or approval of 

a new animal drug application 

(§ 511.1(b)(8)(i)). 

Description of Respondents: 

Respondents to this collection of 

information are persons who use new 

animal drugs for investigational 

purposes. Investigational new animal 

drugs are used primarily by drug 

industry firms, academic institutions, 

and the government. Investigators may 

include individuals from these entities, 

as well as research firms and members 

of the medical professions. 

FDA estimates the burden of this 

collection of information 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 

511.1(b)(4); submission of NCIE ............................................... 279 5.94 1,657 1 1,657 

511.1(b)(5); submission of data to obtain authorization for the 

use of edible food products .................................................... 279 0.10 28 8 224 

511.1(b)(6); submission of any additional information upon request of FDA .......................................................................... 279 .001 0.28 1 0.28 

511.1(b)(8)(ii); reporting of findings that may suggest significant hazards pertinent to the safety of the new animal drug 279 0.05 14 2 28 

511.1(b)(9); reporting by importers of investigational new animal drugs for clinical investigational use in animals .............. 279 0.05 14 8 112 

Total .................................................................................... ........................ ........................ 1,713 ........................ 2,021 

1There 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 No. of recordkeepers 

No. of records 

per recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

511.1(a)(3); maintain records showing the name and post office address of the expert or expert organization to whom 

the new animal drug is shipped and the date, quantity, and 

batch or code mark of each shipment and delivery for a period of 2 years after such shipment or delivery ..................... 279 0.99 276 1 276 

511.1(b)(3); maintain records showing the name and post office address of the expert or expert organization to whom 

the new animal drug or feed containing same is shipped 

and the date, quantity, and batch or code mark of each 

shipment and delivery for a period of 2 years after such 

shipment or delivery ............................................................... 279 5.94 1,657 1 1,657 

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