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
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32879 

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– 

2018–D–2515 for ‘‘Hypertension: 

Conducting Studies of Drugs to Treat 

Patients on a Background of Multiple 

Antihypertensive Drugs; Draft Guidance 

for Industry; Availability.’’ Received 

comments 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. 

• 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.gpo.gov/ 

fdsys/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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Grant, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4160, 

Silver Spring, MD 20903, 301–796– 

2240. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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. Sponsors have 

approached FDA to discuss 

development programs for drugs 

intended to treat resistant hypertension, 

which sponsors have defined as 

hypertension not adequately controlled 

by maximally tolerated doses of three or 

more antihypertensive drugs with 

different mechanisms of action. FDA 

encourages development of additional 

classes of drugs for hypertension, 

particularly classes of drugs that 

demonstrate effects when added to 

currently available therapies. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on conducting studies of drugs to treat 

hypertension in patients on a 

background of multiple 

antihypertensive drugs. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. The collection of 

information in the guidance for industry 

entitled ‘‘Hypertension Indication: Drug 

Labeling for Cardiovascular Outcome 

Claims’’ (available at https://

www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/ 

document/ucm075072.pdf) has been 

approved under OMB control number 

0910–0670. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 


sradovich on DSK3GMQ082PROD with NOTICES
32880 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 

Dated: July 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15092 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–N–1011] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Petition To 

Request an Exemption From 100 

Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements 

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 0910–0608. 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. 

Petition To Request an Exemption From 

100 Percent Identity Testing of Dietary 

Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements—21 CFR 111.75(a)(1)(ii) 

OMB Control Number 0910–0608— 

Extension 

This information collection supports 

Agency regulations. The Dietary 

Supplement Health and Education Act 

(Pub. L. 103–417) added section 402(g) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 342(g)), 

which provides, in part, that the 

Secretary of Health and Human Services 

may, by regulation, prescribe good 

manufacturing practices for dietary 

supplements. Section 402(g)(1) of the 

FD&C Act states that a dietary 

supplement is adulterated if it has been 

prepared, packed, or held under the 

types of conditions that do not meet 

current good manufacturing practice 

regulations. Section 701(a) of the FD&C 

Act (21 U.S.C. 371(a)) gives us the 

authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

Part 111 (21 CFR part 111) establishes 

the minimum Current Good 

Manufacturing Practice (CGMP) 

necessary for activities related to 

manufacturing, packaging, labeling, or 

holding dietary supplements to ensure 

the quality of the dietary supplement. 

Section 111.75(a)(1) of our regulations 

(21 CFR 111.75(a)(1)) establishes a 

procedure for a petition to request an 

exemption from 100 percent identity 

testing of dietary ingredients. Under 

§ 111.75(a)(1)(ii), manufacturers may 

request an exemption from the 

requirements set forth in 

§ 111.75(a)(1)(i) when the dietary 

ingredient is obtained from one or more 

suppliers identified in the petition. The 

regulation clarifies that we are willing to 

consider, on a case-by-case basis, a 

manufacturer’s conclusion, supported 

by appropriate data and information in 

the petition submission, that it has 

developed a system that it would 

implement as a sound, consistent means 

of establishing, with no material 

diminution of assurance compared to 

the assurance provided by 100 percent 

identity testing, the identity of the 

dietary ingredient before use. 

Section 111.75(a)(1) reflects our 

determination that manufacturers that 

test or examine 100 percent of the 

incoming dietary ingredients for 

identity can be assured of the identity 

of the ingredient. However, we 

recognize that it may be possible for a 

manufacturer to demonstrate, through 

various methods and processes in use 

over time for its particular operation, 

that a system of less than 100 percent 

identity testing would result in no 

material diminution of assurance of the 

identity of the dietary ingredient as 

compared to the assurance provided by 

100 percent identity testing. To provide 

an opportunity for a manufacturer to 

make such a showing and reduce the 

frequency of identity testing of 

components that are dietary ingredients 

from 100 percent to some lower 

frequency, we added to § 111.75(a)(1), 

an exemption from the requirement of 

100 percent identity testing when a 

manufacturer petitions the Agency for 

such an exemption to 100 percent 

identity testing under § 10.30 (21 CFR 

10.30) and the Agency grants such 

exemption. Such a procedure would be 

consistent with our stated goal, as 

described in the CGMP final rule, of 

providing flexibility in the CGMP 

requirements. Section 111.75(a)(1)(ii) 

sets forth the information a 

manufacturer is required to submit in 

such a petition. The regulation also 

contains a requirement to ensure that 

the manufacturer keeps our response to 

a petition submitted under 

§ 111.75(a)(1)(ii) as a record under 

§ 111.95 (21 CFR 111.95). The collection 

of information in § 111.95 has been 

approved under OMB control number 

0910–0606. 

In the Federal Register of April 9, 

2018 (83 FR 15159), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

suggesting that ‘‘microbial cultures and 

probiotics should not be required to go 

through such a process to ensure 

exemption from the Agency’s 100 

percent identity testing requirement,’’ 

but did not suggest a revision to the 

estimated burden. We appreciate this 

comment, however, we believe that the 

current requirements impose minimal 

information collection while 

simultaneously ensuring the safety of 

dietary supplements. 

We estimate the burden of the 

information collection as follows: 


sradovich on DSK3GMQ082PROD with NOTICES