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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Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 38103 

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– 

2007–D–0369 for ‘‘Draft Guidance for 

Cilastatin Sodium; Imipenem; 

Relebactam.’’ 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 

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 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: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398 and/or 

PSG-QUESTIONS@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

draft guidance on a generic Cilastatin 

Sodium; Imipenem; Relebactam for 

injection. 

FDA initially approved new drug 

application 212819 RECARBRIO 

(cilastatin sodium; imipenem; 

relebactam for injection) in July 2019. 

We are now issuing a draft guidance for 

industry on generic cilastatin sodium; 

imipenem; relebactam for injection 

(‘‘Draft Guidance on Cilastatin Sodium; 

Imipenem; Relebactam’’). 

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, among other things, the design of BE 

studies to support ANDAs for cilastatin 

sodium; imipenem; relebactam for 

injection. 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 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 12, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15170 Filed 7–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 


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