Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:
- Whether the information collection is necessary and useful to carry out the proper functions of the agency;
- The accuracy of the agency's estimate of the information collection burden;
- The quality, utility, and clarity of the information to be collected; and
- Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
Under the PRA, the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section are to be considered. Due to the complexity of this regulation, and to avoid redundancy of effort, we are referring readers to Section IV (Regulatory Impact Analysis) above, to review the detailed cost assumptions associated with these PRA requirements. We explicitly seek, and will consider public comment on our cost assumptions, as they relate to the PRA requirements summarized in this section.
|§ 160.204||Process for requesting exceptions.||160|
|§ 164.506||General standards and implementation specifications for uses and disclosures of protected health information.||*TBD|
|§ 164.508||Standards and implementation specifications for uses and disclosures for which individual authorization would be required.||3,561,076|
|§ 164.510||Standards and implementation specifications for uses and disclosures for which individual authorization would not be required.||8,903|
|§ 164.512||Notice of privacy practices; rights and procedures.||7,273,952|
|§ 164.514||Access to protected health information; rights and procedures.||*TBD|
|§ 164.515||Accounting for uses and disclosures of protected health information||*TBD|
|§ 164.516||Amendment and correction; rights and procedures||*TBD|
|§ 164.520||Development and documentation of policies and procedures||2,927,000|
|§ 164.522||Compliance and Enforcement||2,500|
* Burden to be determined based upon public comment.