Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24169 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: To receive Head Start 

funding, Head Start grant recipients 

must apply for such funds through this 

information collection. The information 

submitted by applicants assists program 

and grant officials in determining 

whether the applicant meets the 

requirements for funding under the 

Head Start Act including any 

requirements specified in annual 

appropriations by Congress. 

Respondents: Head Start grant 

recipients. 

ANNUAL BURDEN ESTIMATES

Instrument Total number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Annual burden 

hours 

Head Start Grant Application ........................................................... 1,600 2.5 25 100,000 

Estimated Total Annual Burden 

Hours: 100,000. 

Authority: 42 U.S.C. 9801 et seq. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–08651 Filed 4–21–22; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–0759] 

Drug Products, Including Biological 

Products, That Contain Nanomaterials; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Drug 

Products, Including Biological Products, 

That Contain Nanomaterials.’’ This 

guidance finalizes the draft guidance 

issued December 18, 2017, developed to 

provide industry with the Agency’s 

current thinking for the development of 

human drug products, including those 

that are biological products, in which a 

nanomaterial is present in the finished 

dosage form. The guidance also includes 

recommendations for applicants and 

sponsors of investigational, premarket, 

and postmarket submissions for these 

products. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 22, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2017–D–0759 for ‘‘Drug Products, 

Including Biological Products, That 

Contain Nanomaterials.’’ 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, 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 


lotter on DSK11XQN23PROD with NOTICES1
24170 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this 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 guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Kavita Vyas, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4154, Silver Spring, 

MD, 20993–0002, 301–796–4787; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD, 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Drug 

Products, Including Biological Products, 

That Contain Nanomaterials.’’ This 

guidance applies to human drug 

products, including those that are 

biological products, in which a 

nanomaterial is present in the finished 

dosage form. This guidance discusses 

both general principles and specific 

considerations for developing drug 

products containing nanomaterials 

through abbreviated pathways. 

Considerations for quality, nonclinical, 

and clinical studies are discussed as 

they relate to drug products containing 

nanomaterials throughout product 

development and production. 

This guidance finalizes the draft 

guidance issued December 18, 2017 (82 

FR 60019). There were two noteworthy 

changes made from the draft version to 

final guidance in response to 

stakeholder comments. First, the final 

guidance provides a glossary of 

terminology to assist in understanding 

how important terms are used in the 

document. Second, several revisions 

were made to reflect FDA’s current 

thinking with respect to abbreviated 

applications, including abbreviated new 

drug applications (ANDAs), for products 

containing nanomaterials. In addition to 

changes in response to comments, the 

final guidance document’s discussion 

regarding over-the-counter (OTC) 

monograph drugs has been updated for 

consistency with the enactment of OTC 

reform provisions of the Coronavirus 

Aid, Relief, and Economic Security Act 

(Pub. L. 116–136). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Drug Products, 

Including Biological Products, That 

Contain Nanomaterials.’’ 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information, related to investigational 

new drug applications, in 21 CFR part 

312 have been approved under OMB 

control number 0910–0014. The 

collections of information, related to 

new drug applications and ANDAs, 

including supplemental applications, in 

21 CFR part 314 have been approved 

under OMB control number 0910–0001. 

The collections of information in 

section 351(k) of the Public Health 

Service Act (42 U.S.C. 262(k)), regarding 

biosimilar applications, have been 

approved under OMB control number 

0910–0718. The collections of 

information, related to biologics license 

applications, in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. The collections of 

information, related current good 

manufacturing process requirements, in 

21 CFR part 211 have been approved 

under OMB control number 0910–0139. 

The collections of information, related 

to environmental impact requirements, 

in 21 CFR part 25 have been approved 

under OMB control number 0910–0322. 

The collections of information related to 

controlled correspondence regarding 

generic drug development have been 

approved under OMB control number 

0910–0797. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: April 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08572 Filed 4–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0490] 

Policy Regarding N-acetyl-L-cysteine: 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Policy 

Regarding N-acetyl-L-cysteine: Draft 

Guidance for Industry.’’ The draft 

guidance, when finalized, will explain 

our intent to exercise enforcement 

discretion with respect to the sale and 

distribution of certain products that 

contain N-acetyl-L-cysteine (NAC) and 

are labeled as dietary supplements. This 

enforcement discretion policy would 

apply to products that would be 

lawfully marketed dietary supplements 

if NAC were not excluded from the 

definition of ‘‘dietary supplement’’ and 

that are not otherwise in violation of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). 

DATES: Submit either electronic or 

written comments on the draft guidance 


lotter on DSK11XQN23PROD with NOTICES1