Notice2024-16491
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 26, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 144 (Friday, July 26, 2024)</title>
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[Federal Register Volume 89, Number 144 (Friday, July 26, 2024)]
[Notices]
[Pages 60635-60636]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16491]
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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 24,
2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0056 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#4926242b092a2d2a672e263f"><span class="__cf_email__" data-cfemail="432c2e21032027206d242c35">[email protected]</span></a>.
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
[[Page 60636]]
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 Annual Provider 60 1 20/60 20
synthetic nucleic acids and and
bench top nucleic acid Manufacturer
synthesis equipment. Self-
Attestation
Statement.
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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. 2024-16491 Filed 7-25-24; 8:45 am]
BILLING CODE 4163-18-P
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