2014-26055. Agency Information Collection Activities; Proposed Collection; Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement with change of a previously-approved information collection assigned OMB control number 0955-0013 which expired on July 31, 2014, and for additional information collection requirements found at 45 CFR 170.523(f)(8) and 170.540(c). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.

DATES:

Comments on the ICR must be received on or before January 2, 2015.

ADDRESSES:

Submit your comments to [e-mail] or by calling [phone].

FOR FURTHER INFORMATION CONTACT:

Information Collection Clearance staff, [e-mail] or [phone].

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the document identifier HHS-OS-0955-0013 60-D for reference.

Information Collection Request Title: ONC HIT Certification Program

Abstract: The OS/Office of the National Coordinator for Health Information Technology (ONC) is requesting approval by OMB for reinstatement with change of a previously approved collection of information (OMB control number 0990-0013). We seek to add the collection of information requirement in § 170.523(f)(8) for ONC-ACBs to report to ONC a hyperlink with each EHR technology they certify that provides the public with the ability to access the test results used to certify the EHR technology. We also seek to add the collection of information requirement in § 170.540(c) for ONC-ACBs to submit a renewal request, containing any updates to the information in § 170.520, every three years. Under the ONC HIT Certification Program, accreditation organizations that wish to become the ONC-Approved Accreditor (ONC-AA) must submit certain information, organizations that wish to become and remain an ONC-ACB must submit the information specified by the application and renewal requirements, and ONC-ACBs must comply with collection and reporting requirements, records retention requirements, and submit annual surveillance plans and annually report surveillance results.

In the Permanent Certification Program final rule (76 FR 1312-14), we solicited public comment on each of the information collections associated with the requirements described in regulation at 45 CFR 170.503(b), 170.520, and 170.523(f), (g), and (i), respectively. In the “2014 Edition” final rule (77 FR 54275-76), we sought comment on these collection requirements again and on the information collection requirement at § 170.523(f)(8).

We anticipate that there will continue to be three ONC-ACBs participating in the ONC HIT Certification Program as this is the current number of ONC-ACBs. Therefore, we have aligned the estimated number of respondents for the applicable regulation provisions (i.e., §§ 170.523(f), 170.523(i), and 170.540(c)) with the current number of ONC-ACBs. We have also revised the estimated number of respondents for § 170.520 (new applicants for ONC-ACB status) based on past application and authorization processes for ONC-ACBs. Similarly, we have revised the estimated number of respondents for § 170.503(b) (applicants for ONC-AA status) based on past selection processes for the ONC-AA. We have retained the same number of responses per respondent and average burden hours per response for the regulation provisions previously included in OMB control number 0995-0013.

Likely Respondents: ONC-Approved Accreditors and ONC-Authorized Certification Bodies

Total Estimated Annualized Burden—Hours

Type of respondent	Number of respondents	Number of responses per respondent	Burden hours per response	Total burden hours
45 CFR 170.503(b)	2	1	1	2
45 CFR 170.520	1	1	1	1
45 CFR 170.523(f)	3	52	1.33	207
45 CFR 170.523(g)	n/a	n/a	n/a	n/a
45 CFR 170.523(i)	3	2	1	6
45 CFR 170.540(c)	3	1	1	3
Total burden hours for OMB control number 0955-0013				219

OS specifically request comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Darius Taylor,

Information Collection Clearance Officer.