Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 38101 

departments. These data are routinely 

collected through the occupational 

supplement to the National Electronic 

Injury Surveillance System (NEISSWork). The second data source, for 

which NIOSH is seeking OMB approval, 

is responses to telephone interview 

surveys of the injured and exposed 

firefighters identified within NEISSWork. 

The proposed one-year extension of 

the telephone interview surveys will 

supplement NEISS-Work data with a 

description of firefighter injuries and 

exposures, including worker 

characteristics, injury types, injury 

circumstances, injury outcomes, and use 

of personal protective equipment (PPE). 

Previous reports describing 

occupational injuries and exposures to 

firefighters provide limited details on 

specific regions or sub-segments of the 

population. As compared to these 

earlier studies, the scope of the 

telephone interview data will be 

broader, as it includes sampled cases 

nationwide, and has no limitations 

regarding type of employment (i.e., 

volunteer versus career). Results from 

telephone interviews will be analyzed 

and reported as a case series. 

The sample size for the telephone 

interview survey is estimated to be 

approximately 35 firefighters annually. 

This is based on the current survey 

completion rate of about 11%. While 

this completion rate is lower than 

originally expected, the project team 

still expects to gain additional insight to 

injuries and exposures that firefighters 

incur. 

The NIOSH Division of Safety 

Research (DSR) is conducting this 

project. DSR has a strong interest in 

improving surveillance of firefighter 

injuries and exposures, to provide the 

information necessary for effectively 

targeting and implementing prevention 

efforts, and consequently reducing 

occupational injuries and exposures to 

firefighters. The Consumer Product 

Safety Commission (CPSC) will also 

contribute to this project, as they are 

responsible for coordinating the 

collection of all NEISS-Work data, and 

for overseeing the collection of all 

telephone interview data. 

NIOSH request approval for an 

estimated 18 burden hours annually. 

There is no cost to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Firefighters ............................ Firefighter Follow-Back Survey .................... 35 1 30/60 18 

Total ............................... ....................................................................... ........................ ........................ ........................ 18 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–15230 Filed 7–16–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–21–21DJ] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled Assessment of a 

Training Program to Improve Continuity 

of Care for Children and Families 

Affected by Fetal Alcohol Spectrum 

Disorders (FASD) to the Office of 

Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on March 8, 

2021 to obtain comments from the 

public and affected agencies. CDC did 

not receive comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) 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; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) 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 submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

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. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Assessment of a Training Program to 

Improve Continuity of Care for Children 

and Families Affected by Fetal Alcohol 

Spectrum Disorders (FASD)—New— 

National Center on Birth Defects and 

Developmental Disabilities (NCBDDD), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The purpose of this information 

collection is to assess a curriculum for 

training pediatric residents to identify, 

refer and care for children with prenatal 

exposure to alcohol or a fetal alcohol 

spectrum disorder (FASD). The 

curriculum was developed by the 


lotter on DSK11XQN23PROD with NOTICES1
38102 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 

American Academy of Pediatrics (AAP) 

with support from CDC. The curriculum 

uses a Train-the-Trainer model whereby 

attending physicians at developmental 

continuity clinics receive in-depth 

training and then facilitate training of 

first-year pediatric residents in their 

own clinics. 

In Phase One, training for attending 

physicians will be organized around 

four presentations by experts in the 

identification, diagnosis, and care of 

children with FASD and their families. 

Pre/post-test assessments will be 

obtained for each presentation, followed 

by an overall assessment at the end of 

the training day. 

In Phase Two, the attending 

physicians will implement a curriculum 

of continuing medical education 

activities with their first-year pediatric 

residents. Required activities for 

residents include viewing three prerecorded video presentations. Changes 

in residents’ knowledge of training 

content will be assessed both before and 

after the video presentations. 

Pre/post-test data will be collected 

through paper-and-pencil surveys for inperson training of attending physicians, 

and by secure email for resident 

trainees. Attending physicians will also 

be asked to participate in a final project 

debriefing conference call. 

The purpose and use of the 

assessment data will be to assure that 

specific information in the FASD 

training curriculum is conveyed and 

understood by participants. The public 

health goal is to strengthen the 

identification, referral, and care of 

children with prenatal exposure to 

alcohol. 

OMB approval is requested for three 

years. Approximately 10 clinics will be 

recruited each year. Respondents will be 

one attending physician per clinic, and 

approximately 25 pediatric residents per 

clinic. Participation is voluntary and 

there are no costs to respondents other 

than their time. The total estimated 

annualized burden is 223 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hours) 

Pediatrician (Attending Physician) ... Attending Physicians Screening & Diagnosis Pretest .. 10 1 10/60 

Attending Physicians Screening & Diagnosis Posttest 10 1 10/60 

Attending Physicians Treatment Across Lifespan Pretest.10 1 10/60 

Attending Physicians Treatment Across Lifespan 

Posttest.

10 1 10/60 

Attending Physicians Overcoming Social Attitudes 

Pretest.

10 1 10/60 

Attending Physicians Overcoming Social Attitudes 

Posttest.

10 1 10/60 

Attending Physicians Educational Care Pretest ........... 10 1 10/60 

Attending Physicians Educational Care Posttest ......... 10 1 10/60 

Attending Physicians Training Program Assessment ... 10 1 15/60 

Attending Physicians Overall Program Assessment .... 10 1 20/60 

Attending Physicians Debriefing Guide ........................ 10 1 1 

Attending Physicians Application (A15) ........................ 10 1 10/60 

Pediatrician (Resident) ..................... Resident Overall Effects & Prevalence Video Pretest 250 1 15/60 

Resident Overall Effects & Prevalence Video Posttest 250 1 15/60 

Resident Overall Program Assessment ........................ 250 1 15/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2021–15227 Filed 7–16–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidance for 

Cilastatin Sodium; Imipenem; 

Relebactam; 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 Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Draft 

Guidance for Cilastatin Sodium; 

Imipenem; Relebactam.’’ The draft 

guidance, when finalized, will provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs) for cilastatin sodium; 

imipenem; relebactam for injection. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 17, 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 


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