Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices 60211 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2023–18806 Filed 8–30–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0940] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Rapid Response 

Surveys 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 2, 

2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0500. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10 a.m.–12 p.m., 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–3794, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Rapid Response Surveys 

OMB Control Number 0910–0500— 

Extension 

This generic information collection 

supports research conducted by FDA, as 

authorized under section 1003(d)(2) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 393(d)(2)). 

FDA is requesting extension of OMB 

approval to conduct rapid response 

surveys (RRS). Through these surveys, 

FDA seeks to determine whether a 

problem impacts the public health and 

to quickly obtain vital information about 

risks and interventions. FDA will use 

the information gathered from these 

surveys to make quick turnaround 

decisions about safety problems or risk 

management solutions so the Agency 

may take appropriate public health 

action including dissemination of 

information as necessary. Participation 

in these surveys is voluntary. 

Respondents may include 

manufacturers and distributors of 

biologics, drugs, food, animal food and 

drugs, dietary supplements, food 

additives, cosmetics, medical devices, 

and tobacco products; distributors; 

sponsors and importers; consumers; 

healthcare professionals; hospitals; 

specialized medical facilities (e.g., 

cardiac surgery, obstetrics/gynecology 

services, pediatric services, etc.) and 

other user facilities including nursing 

homes, ambulatory surgical and 

outpatient diagnostic and treatment 

facilities when FDA must quickly 

determine whether or not a problem 

impacts the public health. Once FDA 

understands the need for additional 

surveillance data to address a potential 

public health hazard, the appropriate 

respondents will be identified for each 

unique RRS. 

In the Federal Register of April 20, 

2023 (88 FR 24423), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment, 

which was generally supportive of 

FDA’s use of RRS. (Comment) The 

comment suggested that FDA 

‘‘authorize, develop, and implement a 

mechanism that provides States and the 

most local level of public health 

departments immediate notification and 

access to RRS results when the FDA 

issues a RRS wholly or partially in their 

areas of jurisdiction.’’ (Response) FDA 

already has in place mechanisms to 

share pertinent health information with 

State, local, and tribal authorities. We 

currently share aggregated data (without 

personally identifiable information) of 

hospital reporting RRS. However, FDA’s 

use of RRS has not recently developed 

data about potential safety problems or 

risk management solutions that would 

require development of a new 

mechanism for immediate notification 

and access to RRS results. For example, 

FDA used a RRS to identify and 

maintain a list of drugs essential for the 

care and management of hospitalized 

patients with COVID–19, particularly 

for ventilated patients in the intensive 

care units. FDA used the information to 

help to identify drugs that may be at risk 

of a regional or national shortage, and to 

help ensure these drugs remain 

available to meet the needs of our 

nation. FDA also used a RRS to engage 

stakeholders when developing the food 

safety surveillance sampling 

assignments. FDA shared information 

with key external stakeholders on the 

hot pepper and cucumber sampling 

assignments and garnered industry 

feedback through survey questions to 

ensure that sample collection is done as 

effectively and efficiently as possible. 

Neither of these surveys developed 

information that would require 

development of a new mechanism for 

immediate notification and access to 

RRS results. The latest update survey 

data from FDA can be found here: 

https://www.fda.gov/science-research/ 

fda-science-forum/fda-covid-19-criticalcare-drug-monitoring-survey-portalongoing-surveillance-critical-drugsrelated. Please also note that if you or 

your hospital stakeholders are 

experiencing a drug shortage and need 

assistance on how to obtain supply, 

please refer to the information at 

Drugshortages@fda.hhs.gov. FDA Drug 

Shortage Staff responds to all reports 

received on a daily basis. 

FDA estimates the burden of this 

collection of information as follows: 


ddrumheller on DSK120RN23PROD with NOTICES1
60212 Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

FDA Rapid Response Surveys ................................ 10,000 1 10,000 0.5 (30 minutes) ........ 5,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We estimate that each rapid response 

survey will take no more than 30 

minutes to complete. 

Based on a review of the information 

collection since our last request, we 

have adjusted our burden estimate 

which has resulted in a decrease to the 

currently approved burden. We now 

estimate one response per respondent 

which results in a decrease in overall 

burden of 25,000 hours. 

Dated: August 28, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18832 Filed 8–30–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3136] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Dispute Resolution 

Procedures for Science-Based 

Decisions on Products Regulated by 

the Center for Veterinary Medicine 

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 the information 

collection provisions of the dispute 

resolution procedures for science-based 

decisions on products regulated by the 

Center for Veterinary Medicine (CVM). 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

October 30, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

October 30, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2023–N–3136 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Dispute 

Resolution Procedures for ScienceBased Decisions on Products Regulated 

by the Center for Veterinary Medicine.’’ 

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://

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:// 


ddrumheller on DSK120RN23PROD with NOTICES1