Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32877 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–15149 Filed 7–13–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0341] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Animal Drugs 

for Investigational Use 

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 August 15, 

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 0910–0117. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

New Animal Drugs for Investigational 

Use 

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 an 

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 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 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 foodproducing 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 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 Bio-Research 

Monitoring Program. This program 

permits us to monitor the validity of the 

studies and to 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. 

In the Federal Register of February 

22, 2018 (83 FR 7735), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 


sradovich on DSK3GMQ082PROD with NOTICES
32878 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

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 ......................................... 104 15.38 1,600 1 1,600 

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

the use of edible food products ....................................... 104 0.30 31 8 248 

511.1(b)(6); submission of any additional information upon 

request of FDA ................................................................. 104 0.02 2 1 2 

511.1(b)(8)(ii); reporting of findings that may suggest significant hazards pertinent to the safety of the new animal drug ........................................................................... 104 0.14 15 2 30 

511.1(b)(9); reporting by importers of investigational new 

animal drugs for clinical investigational use in animals ... 104 0.14 15 8 120 

Total .............................................................................. ........................ ........................ 1,663 ........................ 2,000 

1.There 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 Number of 

recordkeepers 

Number 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 ............................................................................. 104 2.5 260 1 260 

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 ........................................ 104 15.38 1,600 1 1,600 

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 .......... 104 15.38 1,600 3.5 5,600 

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

sponsor from investigators ............................................... 104 15.38 1,600 3.5 5,600 

Total .............................................................................. ........................ ........................ 5,060 ........................ 13,060 

1.There 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 104 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. 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. The burden for this information 

collection has changed since the last 

OMB approval. We estimate an overall 

increase in burden that we attribute to 

an increase in the number of annual 

responses and records. 

Dated: July 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15087 Filed 7–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2515] 

Hypertension: Conducting Studies of 

Drugs To Treat Patients on a 

Background of Multiple 

Antihypertensive Drugs; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Hypertension: Conducting Studies of 

Drugs to Treat Patients on a Background 

of Multiple Antihypertensive Drugs.’’ 

This draft guidance is intended to 

clarify the recommended approach for 

sponsors developing drugs to treat 

hypertension for patients who are on a 

background of multiple 

antihypertensive drugs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 14, 2018 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 


sradovich on DSK3GMQ082PROD with NOTICES