Proposed Collection; 30-Day Comment Request; NIH Information Collection Forms to Support the Genetic Testing Registry (OD)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 30-Day Comment Request; NIH Information Collection Forms to Support the Genetic Testing Registry (OD)

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

DATES:

Comments regarding this information collection are best assured of having their full effect if received by July 30, 2026.

ADDRESSES:

Written 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.

FOR FURTHER INFORMATION CONTACT:

To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ellen Wann, Acting Director, Division of Scientific Data Sharing Policy, Office of Science Policy, Office of the Director, NIH, 6705 Rockledge Dr., Suite 631, Bethesda, MD 20892, non-toll-free number (301) 496-9838;

SciencePolicy@mail.nih.gov.

Formal requests for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION:

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information from those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Proposed Collection Title:

NIH Information Collection Forms to Support the Genetic Testing Registry—0925-0651—Expiration Date January 31, 2025—REINSTATEMENT WITHOUT CHANGE—Office of the Director (OD), National Institutes of Health (NIH).

Need and Use of Information Collection:

Clinical laboratory tests are available for more than 18,000 genetic conditions. The Genetic Testing Registry (GTR) provides a centralized, online location for test developers, manufacturers, and researchers to voluntarily submit detailed information about the availability and scientific basis of their genetic tests. The GTR is of value to clinicians by providing information about the accuracy, validity, and usefulness of genetic tests. The GTR also highlights evidence gaps where additional research is needed. The GTR also has tests for microbes like for SARS-CoV-2 to diagnose COVID-19.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,217 hours.

Estimated Annualized Burden Hours

Type of respondent

Type of form

Estimated annual number of respondents

Number of responses per respondent

Average time per response

(in hours)

Total annual burden hours

Laboratory Personnel Using Bulk Submission (new tests)

Minimal Fields

16

67

18/60

322

Optional Fields

16

67

17/60

304

Laboratory Personnel Not Using Bulk Submission (new tests)

Minimal Fields

51

67

30/60

1,709

Optional Fields

47

67

29/60

1,522

Laboratory Personnel (updated tests)

Annual Review

340

24

10/60

1,360

Total

470

16, 870

5,217

Dated: June 25, 2026.

Matthew J. Memoli,

Principal Deputy Director, National Institutes of Health.

[FR Doc. 2026-13204 Filed 6-29-26; 8:45 am]

BILLING CODE 4167-05-P