SSB - SynNA attestation letter_v2

Work Plan Templates for Self Attestation Statement Template for the Framework for Nucleic Acid Synthesis Screening

[OMB No. if applicable. 0920-xxxx] [OMB expiration date]

Supporting Statement B

Program Official/Contact

Jeffrey M. Zirger, Ph.D.

Health Scientist, Information Collection Review Office, Office of Public Health Ethics and Regulation, Office of Science

Centers for Disease Control and Prevention

P: 770-488-5104

[email protected]

9/10/2024

TABLE OF CONTENTS

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS 3

B1. Respondent Universe and Sampling Methods 3

B2. Procedures for the Collection of Information 3

B3. Methods to Maximize Response Rates and Deal with No Response 3

B4. Tests of Procedures or Methods to be Undertaken 3

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 3

REFERENCES 4

ATTACHMENTS

Attachment 1 – OSTP Framework for Nucleic Acid Synthesis Screening

Attachment 2 – Federal Register Notice

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

B1. Respondent Universe and Sampling Methods

The respondent universe for this information collection includes approximately sixty (60) providers and manufacturers of synthetic nucleic acids and bench top nucleic acid synthesis equipment. There will be no sampling within this group. Providers and Manufacturers will be required to complete an attestation if they wish to sell to federally funded researchers per the Framework for Nucleic Acid Synthesis Screening (Framework), which was released by the Office of Science and Technology Policy (OSTP) in April of 2024. Therefore, sampling a subset of the respondent universe would not meet program monitoring needs.

B2. Procedures for the Collection of Information

Providers and manufacturers of synthetic nucleic acids and bench top nucleic acid synthesis equipment (providers) who choose to sell to federally funded researchers are required to provide an attestation that they are compliant with the Framework. The use of this template framework is optional. Upon completion, the self-attestation will be posted publicly or shared with the customer or federal funding agency upon request. There will be no specialized sampling procedures, so no statistical methods for stratification or sample selection will be employed.

B3. Methods to Maximize Response Rates and Deal with No Response

This is a voluntary form that providers may use if they wish. Thus, no methods to maximize response rates will be used as part of this information collection.

B4. Tests of Procedures or Methods to be Undertaken

There will not be a test of the data collection instruments before it is launched.

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

No individuals outside the agency have been consulted on statistical aspects of the design for this information collection, as there will be no statistical or data analysis. An interagency work group has developed the form itself.