Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 2615 

3. Is a needlestick injury the only 

reasonable route of exposure for 

healthcare workers? Please explain. 

4. Are the assumptions about the 

amount of exposure to pertuzumab in a 

healthcare setting reasonable? Please 

explain. 

5. Is the determination that the 

amount of exposure to pertuzumab in a 

healthcare setting does not constitute a 

hazard for healthcare workers 

reasonably supported by the available 

scientific information? Please explain. 

6. What alternatives could be 

considered to this approach for 

monoclonal antibodies to characterize 

the potential hazard to workers? 

Public and Peer Review Charge for the 

Reevaluation of Liraglutide on the 

NIOSH List of Hazardous Drugs 

The manufacturer’s request to 

reevaluate the inclusion of liraglutide 

on the NIOSH List proposed that it does 

not present a potential hazard to 

healthcare worker exposures because 

the properties of the drug limit the 

potential for exposure and therefore 

adverse health effects from that 

exposure. To reevaluate this drug, 

NIOSH reviewed data regarding the 

hazards and potential for systemic 

exposure to liraglutide. Based on this 

reevaluation NIOSH determined that 

liraglutide does not meet the NIOSH 

definition of a hazardous drug and 

recommends that it be removed from the 

List. Please review the NIOSH 

reevaluation of liraglutide and consider 

the following questions. 

1. Are the evaluated health effects the 

appropriate health effects to evaluate? If 

not, what other health effect(s) should 

be evaluated and why? 

2. Are the assumptions about the 

potential exposures to liraglutide in a 

healthcare setting reasonable? Please 

explain. 

3. Is the determination that the 

amount of exposure to liraglutide in a 

healthcare setting does not constitute a 

hazard for healthcare workers 

reasonably supported by the available 

scientific information? Please explain. 

4. What alternative approaches could 

be considered to characterize the 

potential hazard to workers from 

peptide-based drugs? 

5. Is there any additional information 

that NIOSH should consider in its 

reevaluation of liraglutide? 

References 

FDA [2009]. Liraglutide Pharmacology 

Review. Retrieved from https://www.

accessdata.fda.gov/scripts/cder/daf/. 

FDA [2012]. US Food and Drug 

Administration Pharmacology Review of 

Perjeta. Retrieved from https://www.

accessdata.fda.gov/drugsatfda_docs/ 

nda/2012/125409Orig1s000PharmR.pdf 

NIOSH [2016]. NIOSH list of 

antineoplastic and other hazardous drugs 

in healthcare settings, 2016. By Connor 

TH, MacKenzie BA, DeBord DG, Trout 

DB, O’Callaghan JP. Cincinnati, OH: U.S. 

Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Institute for 

Occupational Safety and Health, DHHS 

(NIOSH) Publication Number 2016–161. 

https://www.cdc.gov/niosh/docs/2016- 

161/ NIOSH [2023]. Procedures for 

developing the NIOSH list of hazardous 

drugs in healthcare settings. By 

Whittaker C, Ovesen JL, MacKenzie BA, 

Hartley T, Berry KA, Piacentino J. 

Cincinnati, OH: U.S. Department of 

Health and Human Services, Centers for 

Disease Control and Prevention, National 

Institute for Occupational Safety and 

Health, DHHS (NIOSH) Publication No. 

2023–129. https://www.cdc.gov/niosh/ 

docs/2023-129/. 

John J. Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2024–00693 Filed 1–12–24; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–24–0576] 

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 ‘‘Possession, 

Use, and Transfer of Select Agents and 

Toxins (42 CFR part 73)’’ 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 August 

15, 2023, to obtain comments from the 

public and affected agencies. CDC did 

not receive any comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

The CDC will accept all comments for 

this proposed information collection 

project. The OMB 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 

Possession, Use, and Transfer of Select 

Agents and Toxins (OMB Control No. 

0920–0576, Exp. 1/31/2024)— 

Revision—Office of Readiness and 

Response (ORR), Centers for Disease 

Control and Prevention (CDC) 

Background and Brief Description 

Subtitle A of the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002, (42 U.S.C. 

262a), requires the United States 

Department of Health and Human 

Services (HHS) to regulate the 

possession, use, and transfer of 

biological agents or toxins that have the 

potential to pose a severe threat to 

public health and safety (select agents 

and toxins). Subtitle B of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(which may be cited as the Agricultural 

Bioterrorism Protection Act of 2002), (7 

U.S.C. 8401), requires the United States 

Department of Agriculture (USDA) to 

regulate the possession, use, and 

transfer of biological agents or toxins 


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2616 Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 

that have the potential to pose a severe 

threat to animal or plant health, or 

animal or plant products (select agents 

and toxins). Accordingly, HHS and 

USDA have promulgated regulations 

requiring individuals or entities that 

possess, use, or transfer select agents 

and toxins to register with the Centers 

for Disease Control and Prevention 

(CDC) or the Animal and Plant Health 

Inspection Service (APHIS). See 42 CFR 

part 73, 7 CFR part 331, and 9 CFR part 

121 (the select agent regulations). The 

Federal Select Agent Program (FSAP) is 

the collaboration of the CDC, Division of 

Regulatory Science and Compliance 

(DRSC) and the APHIS Division of 

Agricultural Select Agents and Toxins 

(DASAT) to administer the select agent 

regulations in a manner to minimize the 

administrative burden on persons 

subject to the select agent regulations. 

Accordingly, CDC and APHIS have 

adopted an identical system to collect 

information for the possession, use, and 

transfer of select agents and toxins. 

CDC is requesting OMB approval to 

continue to collect information under 

the select agent regulations through the 

use of five forms: (1) Application for 

Registration for Possession. Use, and 

Transfer of Select Agents and Toxins 

(APHIS/CDC Form 1); (2) Request to 

Transfer Select Agents or Toxins 

(APHIS/CDC Form 2); (3) Incident 

Notification and Reporting (Theft, Loss, 

or Release) (APHIS/CDC Form 3); (4) 

Reporting the Identification of a Select 

Agent or Toxin (APHIS/CDC Form 4); 

and 5) Request for Exemption of Select 

Agents and Toxins for an Investigational 

Product (APHIS/CDC Form 5). 

An entity may amend its registration 

(Section 7(h)(1)) if any changes occur to 

the information previously submitted to 

FSAP. When applying for an 

amendment to a certificate of 

registration, an entity would complete 

the relevant portion of the application 

package (APHIS/CDC Form 1). 

Besides the forms listed above, there 

is no standard form for the following 

information: 

1. An individual or entity may request 

an exclusion from the requirements of 

the select agent regulations of an 

attenuated strain of a select agent or a 

select toxin modified to be less potent 

or toxic. (Section 3(e) and 4(e)). 

2. Annual inspections that are 

conducted by the entity must be 

documented. (Section 9(a)(6)). 

3. An individual’s security risk 

assessment may be expedited upon 

written request by a Responsible Official 

and a showing of good cause. (Section 

10(f)). 

4. An individual or entity may request 

approval to perform a ‘‘restricted 

experiment’’ (Section 13). 

5. An individual or entity must 

develop and implement a written 

security plan, biosafety plan, and 

incident response plan (Sections 11(a), 

12(a), and 14(a)). 

6. The Responsible Official must 

ensure a record of the training for each 

individual with access to select agents 

and toxins and each escorted individual 

is maintained (Section 15(d)). 

7. An individual or entity may appeal 

a denial, revocation, or suspension of 

registration. (Section 20(a)). 

8. An individual may appeal a denial, 

limitation, or revocation of access 

approval. (Section 20(b)). 

The currently approved annualized 

burden is 4467. CDC requests OMB 

approval for an estimated 3504 annual 

burden hours. The total estimated 

annualized burden for all data 

collection was calculated using the 2021 

Annual Report of the FSAP available at 

https://www.selectagents.gov/resources/ 

publications/annualreport/2021.htm. 

Burden has been reduced due to a 

decrease in the number of respondents. 

Information will be collected through 

the FSAP IT system, email, and hard 

copy mail from respondents. Upon OMB 

approval, CDC will begin use of the 

revised forms in January 2024 through 

January 2027. There is no cost to the 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Section Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Sections 3 & 4 ......... Request for Exclusions .......................................................................... 1 1 1 

Sections 5 & 6 ......... Form 4—Report of Identification of a Select Agent or Toxin ................ 917 1 1 

Sections 5 & 6 ......... Form 5—Request of Exemption ............................................................ 1 1 1 

Section 7 ................. Form 1—Application for Registration .................................................... 5 1 5 

Section 7 ................. Form 1 Sec 6A—Amendment to a Certificate of Registration .............. 144 5 1 

Section 9 ................. Documentation of self-inspection .......................................................... 233 1 1 

Section 10 ............... Request for Expedited Review .............................................................. 1 1 30/60 

Section 11 ............... Security Plan .......................................................................................... 233 1 1 

Section 12 ............... Biosafety Plan ........................................................................................ 233 1 1 

Section 13 ............... Request Regarding a Restricted Experiment ........................................ 3 1 2 

Section 14 ............... Incident Response Plan ......................................................................... 233 1 1

Section 15 ............... Training .................................................................................................. 233 1 1 

Section 16 ............... Form 2—Request to Transfer Select Agents and Toxins ..................... 229 1 1.5 

Section 17 ............... Records .................................................................................................. 233 1 30/60 

Section 19 ............... Form 3—Notification of Theft, Loss, or Release ................................... 185 1 1 

Section 20 ............... Administrative Review ........................................................................... 22 1 1

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–00651 Filed 1–12–24; 8:45 am] 

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