[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Rules and Regulations]
[Pages 47210-47211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18598]



45 CFR Part 5b

RIN 0906-AA97

National Practitioner Data Bank and Privacy Act; Exempt Records 
System; Technical Correction

AGENCY: Health Resources and Services Administration (HRSA).

ACTION: Correcting amendments.


SUMMARY: These correcting amendments update a cross reference cited in 
the Privacy Act regulations. The National Practitioner Data Bank (NPDB) 
system of records (09-15-0054) is exempt from certain provisions of the 
Privacy Act, and the cross reference cited refers to the regulations 
that govern the NPDB. As a result of Section 6403 of the Affordable 
Care Act, the regulations governing the NPDB were revised and certain 
section numbers in the NPDB regulations were changed, including the 
NPDB regulation that was cross referenced. This change is technical in 
nature and does not significantly alter the current NPDB exemption.

DATES: This final rule is effective August 5, 2013.

FOR FURTHER INFORMATION CONTACT: Ernia Hughes, Acting Director, 
Division of Practitioner Data Banks, Bureau of Health Professions, 
Health Resources and Services Administration, Parklawn Building, 5600 
Fishers Lane, Room 8-103, Rockville, Maryland 20857; Telephone (301) 


I. Background

    The NPDB was established by Title IV of Public Law 99-660, the 
Health Care Quality Improvement Act of 1986, as amended. The NPDB is 
primarily an alert or flagging system intended to facilitate a 
comprehensive review of health care practitioners' professional 
credentials. Section 1128E of the Social Security Act, added by the 
Health Insurance Portability and Accountability Act (HIPAA) of 1996, 
(Pub. L. 104-191), created the Health Care Integrity and Protection 
Data Bank (HIPDB). Because a major component of the HIPAA's purpose was 
to establish a health care fraud and abuse control program, the 
legislation required the creation of a national data bank to receive 
and disclose certain adverse actions against health care practitioners, 
providers, and suppliers, thus establishing the HIPDB. Together the 
HIPDB and NPDB served to facilitate the review of health care 
practitioners' and entities' backgrounds, however, some of the 
information collected under the HIPDB is also available under the NPDB.
    In recognition of the overlapping purposes of the laws governing 
the two data banks, and to eliminate the duplicative information in 
both data banks, Section 6403 of the Affordable Care Act required the 
Secretary for the Department of Health and Human Services (HHS) to 
merge the data banks so that information previously collected and 
disclosed under the Section 1128E authority be transferred and made 
available under the NPDB. In addition, Section 6403 ceases HIPDB 
operations. The Affordable Care Act effectively streamlines data 
reporting and disclosure through the merge of the data banks and 
improves program efficiency around reporting and querying. On April 5, 
2013, HRSA published a final rule in the Federal Register (78 FR 
20473), implementing the merge of the HIPDB information into the NPDB. 
The rule became effective on May 6, 2013. All security standards remain 
in place to protect the confidentiality of the NPDB. Section 1128E 
information now reported under the NPDB is still only available to 
those entities authorized to query it.
    Because the statute permits the information collected in the NPDB 
and HIPDB to be used by federal and state government agencies with the 
responsibility of investigating and prosecuting violations of civil and 
criminal laws, the NPDB and HIPDB were made exempt from certain 
portions of the Privacy Act under two separate provisions, 45 CFR 
5b.11(b)(2)(ii)(F) and (L). As cross referenced in this section, the 
access and correction rights of individuals are detailed in the 
regulations governing the NPDB and HIPDB.

II. Summary of the Correction

    This final rule revises the cross reference found in the Privacy 
Act regulations at 45 CFR 5b.11(b)(2)(ii)(L) from Sec.  60.16 to Sec.  
60.21, to reflect the changes made to the NPDB regulation required by 
the Affordable Care Act.
    The system of records notice for the NPDB, which was last published 
in the Federal Register on March 30, 2012, (77 FR 19295), is being 
republished elsewhere in this issue of the Federal Register to reflect 
this change.

III. Waiver of Proposed Rulemaking

    HHS ordinarily publishes a notice of proposed rulemaking in the 
Federal Register to provide a period for public comment before the 
provisions of a rule take effect, in accordance with Section 553(b) of 
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, this 
notice and comment procedure can be waived if the Secretary finds, for 
good cause, that the notice and comment process is impracticable, 
unnecessary, or contrary to the public interest, and incorporates a 
statement of the finding and the reasons therefore in the notice.
    Section 553(d) of the APA ordinarily requires a 30-day delay in 
effective date of final rules after the date of their publication in 
the Federal Register. This 30-day delay in effective date can be 
waived, however, if an agency finds there is good cause to do so, and 
the agency incorporates a statement of the findings and its reasons in 
the rule issued.
    This document is purely technical in nature and merely corrects a 
cross-reference in the Privacy Act regulations at 45 CFR 
5b.11(b)(2)(ii)(L), from Sec.  60.16 to Sec.  60.21. The change is not 
a substantive change and does not alter any rights or obligations. 
Therefore, the Secretary believes that undertaking further notice and 
comment procedures to incorporate this correction, which will delay the 
effective date for this change, is unnecessary. In addition, the 
Secretary believes it is important for the public to have the correct 
information as soon as possible, and further believes it is contrary to 
the public interest to delay the dissemination of it. For the reasons 
stated above, the Secretary finds there is good cause to waive notice 
and comment procedures and the 30-day delay in the effective date for 
this correction notice.

[[Page 47211]]

Economic and Regulatory Impact

    This final rule is technical in nature and does not increase 
regulatory burden. In accordance with the provisions of Executive 
Orders 13563 and 12866 and the Regulatory Flexibility Act (5 U.S.C. 
601-612), the Office of Management and Budget has determined that it 
will have no major effect on the economy or federal expenditures. This 
rule is not economically significant under section 3(f) of Executive 
Order 12866 and is not being treated as a ``significant regulatory 
action'' under section 3(f). Accordingly, the rule has not been 
reviewed by the Office of Management and Budget.
    The Secretary has determined that this final rule is not a ``major 
rule'' within the meaning of the statute providing for Congressional 
Review of Agency Rulemaking, 5 U.S.C. 801, and has determined that it 
does not meet the criteria for a significant regulatory action. In 
addition, under the Small Business Enforcement Act (SBEA) of 1996, if a 
rule has a significant economic effect on a substantial number of small 
businesses, the Secretary must specifically consider the economic 
effect of a rule on small business entities and analyze regulatory 
options that could lessen the impact of the rule. The Secretary has 
reviewed this exemption in accordance with the provisions of the SBEA 
and certifies that this exemption will not have a significant impact on 
a substantial number of small entities.
    Similarly, it will not have effects on state, local, and tribal 
governments and on the private sector such as to require consultation 
under the Unfunded Mandates Reform Act of 1995.
    Executive Order 13132 requires agencies to meet certain 
requirements when a rule has ``federal implications,'' and may have 
``substantial direct effects on the states, or on the relationship 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government.'' 
The Secretary has reviewed this final rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have substantial federalism implications or direct costs and 
implications for the state and local governments.

Paperwork Reduction Act

    This final rule does not have any information collection 

List of Subjects in 45 CFR Part 5b


    Dated: July 5, 2013.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
    Approved: July 26, 2013.
Kathleen Sebelius,
    Amend 45 CFR part 5b as follows:


1. The authority citation for part 5b continues to read as follows:

    Authority: 5 U.S.C. 301, 5 U.S.C. 552a.

2. Revise Sec.  5b.11(b)(2)(ii)(L) to read as follows:

Sec.  5b.11  Exempt systems.

* * * * *
    (b) * * *
    (2) * * *
    (ii) * * *
    (L) Investigative materials compiled for law enforcement purposes 
for the National Practitioner Data Bank (NPDB). (See Sec.  60.21 of 
this subchapter for access and correction rights under the NPDB by 
subjects of the Data Bank.)
* * * * *
[FR Doc. 2013-18598 Filed 8-2-13; 8:45 am]