[Federal Register Volume 89, Number 142 (Wednesday, July 24, 2024)]
[Notices]
[Pages 59916-59917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-24HP; Docket No. CDC-2024-0056]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), 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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Compliance Attestation Statement for the Framework for Nucleic 
Acid Synthesis Screening. The project aims to assist providers and 
manufacturers of synthetic nucleic acids and benchtop nucleic acid 
synthesis equipment (providers) in making an attestation that they have 
instituted a process to screen nucleic acid sequences of concern and 
verify customer legitimacy, in accordance with the requirements outlaid 
in the OSTP Framework for Nucleic Acid Synthesis Screening.

DATES: CDC must receive written comments on or before September 23, 
2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0056 by either of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600

[[Page 59917]]

Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: [email protected].

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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Compliance Attestation Statement for the Framework for Nucleic Acid 
Synthesis Screening--New--Office of Science (OS), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    This data collection form was developed pursuant to the Framework 
for Nucleic Acid Synthesis Screening, which was released by the Office 
of Science and Technology Policy (OSTP) in April of 2024. This 
framework was directed by the Executive Order on the Safe, Secure, and 
Trustworthy Development of Artificial Intelligence, and recommends that 
providers and manufacturers of synthetic nucleic acids screen their 
sequences and customers before fulfilling orders to prevent potential 
misuse.
    The Attestation Form will collect basic organizational information 
and an attestation of compliance from providers and manufacturers of 
synthetic nucleic acids and benchtop nucleic acid synthesis equipment. 
Data collected includes organization name, location, website, and type 
of organization. The form also includes primary and secondary contact 
information such as name, location, phone number and email address to 
ensure there is a point of contact with the company in case of 
questions regarding compliance and record keeping. This data is needed 
to ensure the self-attestation form can be filed and logged correctly, 
and to ensure the government can reach out to the correct contact if 
clarification if necessary.
    CDC requests OMB approval for an estimated 20 annual burden hours. 
There is no cost to respondents other than their time to participate.

                                                            Estimated Annualized Burden Hours
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                                                                                                          Number of      Average burden
               Type of respondents                             Form name                 Number of      responses per     per response     Total burden
                                                                                        respondents       respondent       (in hours)       (in hours)
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Providers and manufacturers of synthetic nucleic  Annual Provider and Manufacturer                60                1            20/60               20
 acids and bench top nucleic acid synthesis        Self-Attestation Statement.
 equipment.
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    Total.......................................  ..................................  ...............  ...............  ...............              20
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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. 2024-16233 Filed 7-23-24; 8:45 am]
BILLING CODE 4163-18-P