11296 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Theresa Kingsberry (202–326–3100), 

Program Support Specialist, Federal 

Trade Commission Premerger 

Notification Office, Bureau of 

Competition, Room CC–5301, 

Washington, DC 20024. 

By direction of the Commission. 

Joel Christie, 

Acting Secretary. 

[FR Doc. 2021–03751 Filed 2–23–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended, and the Determination of 

the Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, CDC, pursuant to 

Public Law 92–463. The grant 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the grant applications, the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

CE21–002: Research Grants to Develop 

or Identify Effective Strategies to 

Prevent Overdose Involving Illicit 

Stimulants and Polysubstance Use 

Involving Stimulants. 

Dates: June 15–16, 2021. 

Times: 8:30 a.m.–5:00 p.m., EDT. 

Place: Videoconference. 

Agenda: To review and evaluate grant 

applications. 

FOR FURTHER INFORMATION CONTACT: 

Mikel Walters, Ph.D., Scientific Review 

Officer, National Center for Injury 

Prevention and Control, CDC, 4770 

Buford Highway NE, Mailstop F–63, 

Atlanta, Georgia 30341, Telephone (404) 

639–0913, MWalters@cdc.gov. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–03744 Filed 2–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[60Day–20–0051; Docket No. ATSDR–2020– 

0005] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Agency for Toxic 

Substances and Disease Registry 

(ATSDR), as part of its continuing effort 

to reduce public burden and maximize 

the utility of government information, 

invites the general public and other 

Federal agencies the opportunity to 

comment on a proposed and/or 

continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled ‘‘Assessment of 

Chemical Exposures (ACE) 

Investigations.’’ The purpose of ACE 

Investigations is to focus on performing 

rapid epidemiological assessments to 

assist state, regional, local, or tribal 

health departments (the requesting 

agencies) to respond to or prepare for 

acute environmental incidents. 

DATES: ATSDR must receive written 

comments on or before April 26, 2021. 

ADDRESSES: You may submit comments, 

identified by Docket No. ATSDR–2020– 

0005 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. ATSDR will post, 

without change, all relevant comments 

to Regulations.gov. 

Please note: Submit all comments through 

the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7118; Email: omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

5. Assess information collection costs. 

Proposed Project 

Assessment of Chemical Exposures 

(ACE) Investigations (OMB Control No. 

0923–0051)—Reinstatement with 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 11297 

Change—Agency for Toxic Substances 

and Disease Registry (ATSDR). 

Background and Brief Description 

The Agency for Toxic Substances and 

Disease Registry (ATSDR) is requesting 

a three-year Paperwork Reduction Act 

(PRA) clearance for the Revision of 

‘‘Assessment of Chemical Exposures 

(ACE) Investigations’’ information 

collection request (ICR) (OMB Control 

No. 0923–0051; Expiration Date 03/31/ 

2021). ATSDR conducts ACE 

Investigations to assist state and local 

health departments after acute 

environmental incidents. 

ATSDR has successfully completed 

five investigations to date using this 

valuable mechanism. ATSDR would like 

to continue these impactful information 

collections. A brief summary of recent 

information collections approved under 

this tool includes the following: 

• During 2015, in U.S. Virgin Islands 

there was a methyl bromide exposure 

incident at a condominium resort 

severely injuring a family and causing 

symptoms in the first responders to the 

incident. ATSDR interviewed all 

potentially exposed persons who stayed 

or worked at the resort to look for signs 

of exposure. Under this ACE 

investigation, ATSDR raised awareness 

among pest control companies that 

methyl bromide is currently prohibited 

in homes and other residential settings. 

Additionally, ATSDR raised awareness 

among clinicians about the toxicologic 

syndrome caused by exposure to methyl 

bromide and the importance of notifying 

first responders immediately when they 

have encountered contaminated 

patients. 

• During 2016, the ACE Team 

conducted a rash investigation in Flint, 

Michigan. Persons who were exposed to 

Flint municipal water and had current 

or worsening rashes were surveyed and 

referred to free dermatologist screening 

if desired. Findings revealed that when 

the city was using water from the Flint 

River, there were large swings in 

chorine, pH, and hardness, which could 

be one possible explanation for the 

eczema-related rashes. 

• During 2016, the ACE Team also 

conducted a follow-up investigation for 

people who were referred to a 

dermatologist in the first Flint 

investigation. The follow-up interviews 

resulted in improvements in medical 

exam and referral processes that were 

still on-going at the time. 

The ACE Investigations have focused 

on performing rapid epidemiological 

assessments to assist state, regional, 

local, or tribal health departments (the 

requesting agencies) to respond to or 

prepare for acute chemical releases. 

The main objectives for performing 

these rapid assessments are to: 

• Characterize exposure and acute 

health effects of the affected community 

to inform health officials and the 

community; 

• Identify needs (i.e., medical, mental 

health, and basic) of those exposed 

during the incidents to aid in planning 

interventions in the community; 

• Determine the sequence of events 

responsible for the incident so that 

actions can be taken to prevent future 

incidents; 

• Assess the impact of the incidents 

on the emergency response and health 

services use and share lessons learned 

for use in hospital, local, and state 

planning for environmental incidents; 

and 

• Identify cohorts that may be 

followed and assessed for persistent 

health effects resulting from 

environmental releases. 

Because each incident is different, it 

is not possible to predict in advance 

exactly what type of, and how many 

respondents will be consented and 

interviewed to effectively evaluate the 

incident. Respondents typically include, 

but are not limited to, emergency 

responders such as police, fire, 

hazardous material technicians, 

emergency medical services, and 

personnel at hospitals where patients 

from the incident were treated. 

Incidents may occur at businesses or in 

the community setting; therefore, 

respondents may also include business 

owners, managers, workers, customers, 

community residents, and those passing 

through the affected area. 

The multidisciplinary ACE Team 

consisting of staff from ATSDR, the 

Centers for Disease Control and 

Prevention (CDC), and the requesting 

agencies will be collecting data. ATSDR 

has developed a quickly tailored series 

of draft survey forms used in the field 

to collect data that will meet the goals 

of the investigation. ATSDR collections 

will be administered based on time 

permitted and urgency. For example, it 

is preferable to administer the General 

Survey to as many respondents as 

possible. However, if there are time 

constraints, the shorter Household 

Survey or the former ACE Short Form, 

now modified as the Epidemiologic 

Contact Assessment Symptom Exposure 

(Epi CASE) Survey, may be 

administered instead. The individual 

surveys collect information about 

exposure, acute health effects, health 

services use, medical history, needs 

resulting from the incident, 

communication during the release, 

health impact on children, and 

demographic data. Hospital personnel 

are asked about the surge, response and 

communication, decontamination, and 

lessons learned. 

Depending on the situation, data 

collected by face-to-face interviews, 

telephone interviews, written surveys, 

mailed surveys, or on-line surveys can 

be collected. Medical charts may also be 

considered for review. In rare situations, 

an investigation might involve 

collection of clinical specimens. 

ATSDR is proposing to increase the 

utility of this Generic ICR in response to 

stakeholder requests. We would like to 

expand the ACE toolkit to be more 

inclusive of other types of 

environmental incidents affecting the 

community and which fall under 

ATSDR’s mandate and, at times, the 

mandates of our partners in the CDC’s 

National Center for Environmental 

Health (NCEH) and the National Center 

for Occupational Safety and Health 

(NIOSH). In addition to acute chemical 

releases, we propose to include 

radiological and nuclear incidents, 

explosions, natural disasters, and other 

environmental incidents. 

We propose revisions to select 

information collection forms, which 

will be deployed using handheld 

devices whenever possible to reduce 

burden, and to adjust the number of 

responses and time per response for 

several forms. A new brief Eligibility 

Screener (900 responses per year; 30 

hours) will be added prior to 

administering consent for our surveys. 

The Epi CASE Survey, formerly the ACE 

Short Form, has been modified for the 

expanded scope of eligible incidents 

requested (1,000 responses per year; 250 

hours). To reduce time burden, there 

will be new field data entry screens and 

deletion of unused questions for the 

General Survey (800 responses per year; 

333 hours), the Household Survey (120 

responses per year; 20 hours) and for the 

Hospital Survey (40 responses per year; 

17 hours). We are retaining the Medical 

Chart Abstraction Form (250 responses 

per year; 125 hours) but are removing 

the Veterinary Chart Abstraction Form 

as it has not been used in the past. 

ATSDR anticipates up to four ACE 

investigations per year. We are 

requesting approval for 3,110 annual 

responses (increase of 1,820 responses 

per year) and for 775 annual hours 

(increase of 184 hours per year). 

Participation in ACE investigations is 

voluntary and there are no anticipated 

costs to respondents other than their 

time. 


khammond on DSKJM1Z7X2PROD with NOTICES
11298 Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Total 

burden 

(in hr) 

Residents, first responders, business 

owners, employees, customers.

Eligibility Screener ............................

Epi CASE Survey .............................

900 

1,000 

1 

1 

2/60 

15/60 

30 

250 

General Survey ................................ 800 1 25/60 333 

Residents .......................................... Household Survey ............................ 120 1 10/60 20 

Hospital staff ..................................... Hospital Survey ................................ 40 1 25/60 17 

Staff from state, local, or tribal health 

agencies.

Medical Chart Abstraction Form ...... 25 10 30/60 125 

Total ........................................... ........................................................... ........................ ........................ ........................ 775 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–03703 Filed 2–23–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0672] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prominent and 

Conspicuous Mark of Manufacturers 

on Single-Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 reprocessed, 

single-use device labeling. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 26, 2021. 

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 April 26, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 26, 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– 

2011–N–0672 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Prominent and Conspicuous Mark of 

Manufacturers on Single-Use Devices.’’ 

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:// 


khammond on DSKJM1Z7X2PROD with NOTICES