29788 Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Notices 

studies of silver nanomaterials in 

animals and cellular systems. Based on 

review of the scientific literature, 

NIOSH revised the draft CIB and 

developed a recommended exposure 

limit (REL) for silver nanomaterials. The 

revised draft CIB was released for public 

review with a Federal Register notice 

on September 18, 2018 [83 FR 47174]. 

The notice included a request for 

comments from peer reviewers and the 

public and provided information 

regarding a second public meeting that 

was held on October 30, 2018. The 

purpose of the public review was to 

obtain comments on whether the NIOSH 

draft document (1) adequately and 

clearly described the scientific literature 

on the potential adverse health effects of 

silver nanomaterials, and (2) 

demonstrated that the NIOSH 

recommendations on occupational 

exposure to silver nanomaterials are 

consistent with current scientific 

knowledge. Public, stakeholder, and 

scientific peer reviewers were given the 

opportunity to submit comments to the 

docket by November 30, 2018. 

NIOSH carefully considered the 

comments received on the revised draft 

document. Reviewers provided 

comments on the NIOSH assessment of 

the potential adverse health effects of 

occupational exposure to silver 

nanomaterials, on the data and methods 

NIOSH used to develop a recommended 

exposure limit for silver nanomaterials, 

on the NIOSH recommended methods 

for assessing and controlling exposures 

to silver nanomaterials in the 

workplace, and on the identified data 

gaps and future research needs. In 

developing the final document, NIOSH 

performed an additional systematic 

literature search in April 2019 to 

determine if any subsequent studies in 

animals or humans had been published 

that pertained to the quantitative risk 

assessment and the derivation of a REL 

for silver nanomaterials. No additional 

studies were found that impacted those 

topics. NIOSH responded to the public, 

stakeholder, and peer review comments 

received and developed the final 

document consistent with the responses 

to comments. These comments and the 

NIOSH responses are available at: 

https://www.regulations.gov/search/ 

docket?filter=cdc-2016-0001. 

The final CIB provides a 

comprehensive scientific review of the 

scientific literature pertaining to 

occupational exposure to silver 

nanomaterials. The literature includes 

studies of exposures to silver 

nanomaterials in the workplace, 

toxicological effects of exposure to 

silver nanomaterials in experimental 

animal and cellular systems, and effects 

of particle size and other properties on 

the toxicological effects of silver. NIOSH 

assessed the potential health risks of 

occupational exposure to silver 

nanomaterials by evaluating the 

scientific literature. Studies in animals 

have shown adverse lung and liver 

effects associated with exposure to 

silver nanoparticles. Based on an 

assessment of those data, NIOSH 

developed a REL for silver 

nanomaterials. This new REL applies to 

processes that produce or use silver 

nanomaterials in the workplace. In 

addition, NIOSH continues to 

recommend its existing REL for total 

silver (metal dust and soluble 

compounds, as Ag) [www.cdc.gov/ 

niosh/npg/npgd0557.html]. In the CIB, 

NIOSH provides recommendations on 

the measurement and control of 

occupational exposures to silver and 

silver nanomaterials. 

NIOSH further recommends the use of 

workplace exposure assessments, 

engineering controls, safe work 

procedures, training, and education, and 

established medical surveillance 

approaches to prevent potential adverse 

health effects from occupational 

exposure to silver nanomaterials. 

NIOSH proposes research needed to fill 

remaining data gaps on the potential 

adverse health effects of occupational 

exposure to silver nanomaterials. 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2021–11626 Filed 6–2–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Refugee Support Services 

(RSS) and RSS Set Aside Sub-Agency 

List (0970–0556) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) Office of 

Refugee Resettlement (ORR) seeks 

approval for a revision to an existing 

information collection, requesting 

Refugee Support Services (RSS) grantees 

and RSS Set Aside grantees to provide 

the agency name, city, state, website, 

and funding amount for each contracted 

sub-grantee. Additionally, ORR seeks 

approval to have the option to make this 

information public. This would enhance 

the accessibility of refugee service 

provider information to eligible clients 

in support of the service referral 

responsibilities of the State Refugee 

Coordinators. Similar information for 

ORR’s discretionary grants is currently 

made public. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing infocollection@

acf.hhs.gov. Alternatively, copies can 

also be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation (OPRE), 330 C Street 

SW, Washington, DC 20201, Attn: ACF 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: This data collection 

requests RSS grantees and RSS Set 

Aside grantees to provide the agency 

name, city, state, website, and funding 

amount for each contracted sub-grantee. 

The information will be used for 

national resource mapping pertaining to 

ORR RSS funding at the local level. 

Improved communication and the 

knowledge of all local providers is 

important to ORR’s overall oversight of 

the program. In addition to RSS formula 

funding to states and state replacement 

agencies who then issue sub-awards to 

local providers, ORR also awards 

discretionary grants that directly fund 

local refugee service providers. This 

report will provide ORR a complete 

picture of the availability all ORR 

resources to assist newly arrived 

refugees at the local level increasing our 

ability to identify gaps or target areas of 

need. 

Respondents: State governments and 

replacement designees. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 105 / Thursday, June 3, 2021 / Notices 29789 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number 

of responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual burden 

hours 

RSS and RSS Set Aside Sub-grantee List ......................... 56 3 2 336 112 

Estimated Total Annual Burden 

Hours: 112. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on 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. 

Authority: Refugee Act of 1980 

[Immigration and Nationality Act, Title IV, 

Chapter 2 Section 412 (e)] and 45 CFR 

400.28. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–11653 Filed 6–2–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0391] 

Oral Drug Products Administered via 

Enteral Feeding Tube: In Vitro Testing 

and Labeling Recommendations; 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 ‘‘Oral 

Drug Products Administered Via Enteral 

Feeding Tube: In Vitro Testing and 

Labeling Recommendations.’’ This draft 

guidance provides recommendations for 

consistent in vitro testing of oral drug 

products to demonstrate their suitability 

to be administered via enteral tube. In 

addition, it supports the development of 

clear product-specific enteral tube 

administration instructions in labeling 

for administration to patients unable to 

ingest oral drug products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 2, 2021 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: 

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– 

2021–D–0391 for ‘‘Oral Drug Products 

Administered Via Enteral Feeding Tube: 

In Vitro Testing and Labeling 

Recommendations.’’ 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 

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 


khammond on DSKJM1Z7X2PROD with NOTICES