19294 Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 

systems for the UK population (Ref. 3). 

This peer-reviewed journal article 

presented the following findings 

regarding primary MoM THR: (1) 

Increased failure rate at 5 years for MoM 

THR related to larger head sizes; (2) 

significantly higher risk for revision in 

female patients (Note: In the United 

States, labeling discourages use of MoM 

hips in females of child bearing age with 

warnings in MoM THR labeling and 

contraindications in MoM hip 

resurfacing labeling); and (3) revisions 

for dislocation in men with MoM 

replacements were slightly lower, 

showing some benefit to larger head 

sizes. 

The committee will be asked to 

discuss the following as it pertains to 

these devices in the U.S. population: 

Device mechanisms of failure, metal ion 

testing, imaging methods, local and 

systemic complications, preoperative 

and postoperative patient risk factors, as 

well as clinical followup considerations 

for patients with MoM hip systems 

(total and resurfacing). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: FDA will work with 

affected industry, professional 

organizations, and societies that have an 

interest in the MoM hip arthroplasty 

systems and who wish to make a 

presentation separate from the general 

open public hearing; time slots on June 

28, 2012, between approximately 9 a.m. 

and 10 a.m. Representatives from 

industry, professional organizations and 

societies interested in making formal 

presentations to the committee should 

notify the contact person on or before 

May 1, 2012. 

Interested persons may present data, 

information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

May 9, 2012. On June 27, 2012 oral 

presentations from the public will be 

scheduled between approximately 9 

a.m. and 10 a.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before May 1, 

2012. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 2, 2012. 

Comments: FDA is opening a docket 

to allow for public comments to be 

submitted to the Agency on the issues 

before the Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices Advisory Committee 

beginning on March 30, 2012, and 

closing on May 9, 2012. Interested 

persons are encouraged to use the 

docket to submit electronic or written 

comments regarding this meeting. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Divisions 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact James Clark, 

James.Clark@fda.hhs.gov or 301–796– 

5293 at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

I. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see Comments) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. American Academy of Orthopedic 

Surgeons, ‘‘Modern Metal-on-Metal Hip 

Implants: A Technology Overview’’ (July 

15, 2011), accessed online at http:// 

www.aaos.org/research/overviews/ 

Metal_On_Metal.pdf. 

2. Adelaide: Australian Orthopaedic 

Association, Australian Orthopaedic 

Association National Joint Replacement 

Registry: Annual Report 2010, 2010. 

3. Smith, A.J., P. Dieppe, K. Vernon, et al., 

‘‘Failure Rates of Stemmed Metal-onMetal Hip Replacements: Analysis of 

Data From the National Joint Registry of 

England and Wales,’’ Lancet (March 13, 

2012), accessed online at http:// 

www.thelancet.com/journals/lancet/ 

article/PIIS0140–6736(12)60353-5/ 

fulltext#article_upsell (doi:10.1016/ 

S0140–6736(12)60353–5). 

Dated: March 27, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7767 Filed 3–29–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: May 7, 2012, 8:30 a.m. 

to 5 p.m., May 8, 2012, 8:30 a.m. to 5 p.m. 

Place: Westin Denver Downtown Hotel, 

1672 Lawrence Street, Denver, Colorado 

80202. Telephone: (303) 572–9100. 

Fax: (303) 572–7288. 

Status: The meeting will be open to the 

public. 

Purpose: The purpose of the meeting is to 

discuss services and issues related to the 

health of migrant and seasonal farmworkers 

and their families and to formulate 

recommendations for the Secretary of Health 

and Human Services. 

Agenda: The agenda includes an overview 

of the National Advisory Council on Migrant 

Health’s (The Council) general business 

activities. The Council will also hear 

presentations from experts on farmworker 

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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 19295 

issues, including the status of farmworker 

health at the local and national levels. 

Agenda items are subject to change as 

priorities indicate. 

For Further Information Contact: Gladys 

Cate, Office of Special Population Health, 

Bureau of Primary Health Care, Health 

Resources and Services Administration, 5600 

Fishers Lane, Room 15–62, Rockville, 

Maryland 20857; telephone (301) 594–0367. 

Dated: March 22, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–7613 Filed 3–29–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974; Report of an 

Altered System of Records 

AGENCY: Department of Health and 

Human Services (HHS), Health 

Resources and Services Administration 

(HRSA). 

ACTION: Notice of an Altered System of 

Records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974 

(5 U.S.C. 552a), as amended, the Health 

Resources and Services Administration 

(HRSA) is publishing a notice to alter 

the system of records for the National 

Practitioner Data Bank for Adverse 

Information on Physicians and Other 

Health Care Practitioners, HHS/HRSA/ 

BHPR. The System of Records Notice 

(SORN) 09–15–0054 was last published 

on October 1, 2010 (75 FR 60763). The 

Health Care Quality Improvement Act of 

1986, as amended, title IV of Public Law 

99–660 (42 U.S.C. 11101 et seq.) 

authorized the Secretary to establish a 

National Practitioner Data Bank (NPDB) 

to collect and release certain 

information relating to the professional 

competence and conduct of physicians, 

dentists, and other health care 

practitioners. By law, the information is 

releasable only to the specific entities 

described in the SORN. The law 

requires the maintenance of records 

such as medical malpractice payments, 

adverse licensure and clinical privilege 

actions, disciplinary actions taken by 

Boards of Medical Examiners, and 

professional review actions taken by 

entities against physicians, dentists, and 

other healthcare practitioners. Section 

1921 of the Social Security Act, as 

amended, expands reporting to the 

NPDB to authorize maintenance of 

records of adverse licensure actions and 

negative actions or findings taken by a 

State licensing authority, peer review 

organization, or private accreditation 

entity against all health care 

practitioners or healthcare entities. 

The primary purpose of this alteration 

is to publish the Privacy Act exemptions 

that became necessary after 

implementation of Section 1921, which 

entitles law enforcement agencies to 

access NPDB information and which 

therefore requires a similar exemption 

from certain provisions of the Privacy 

Act that the Healthcare Integrity and 

Protection Data Bank (HIPDB) has for 

investigative materials. Because some of 

the records may be queried by law 

enforcement agencies for investigative 

purposes (i.e., as opposed to 

employment or other purposes), the 

system will be exempt from certain 

Privacy Act requirements to the extent 

necessary to avoid revealing law 

enforcement investigative interest and 

compromising law enforcement 

investigations. Another purpose of this 

alteration is to add a new routine use 

pertaining to system security, which is 

being added to other SORNs published 

by HHS. 

DATES: As required by the Privacy Act 

(5 U.S.C. 552a(r)), HRSA filed an altered 

system of records report with the Chair 

of the House Committee on Oversight 

and Government Reform, the Chair of 

the Senate Committee on Homeland 

Security and Governmental Affairs, and 

the Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), on 

1/25/12. To ensure all parties have 

adequate time in which to comment, the 

altered system will become effective 30 

days from the publication of this notice 

or 40 days from the date it was 

submitted to OMB and Congress, 

whichever is later, unless HRSA 

receives comments that require 

alterations to this notice. 

ADDRESSES: Please address comments to 

Associate Administrator, Bureau of 

Health Professions, Health Resources 

and Services Administration, 5600 

Fishers Lane, Room 8–103, Rockville, 

Maryland 20857. Comments received 

will be available for inspection at this 

same address from 9 a.m. to 3 p.m. 

(Eastern Standard Time Zone), Monday 

through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Practitioner Data 

Banks, Bureau of Health Professions, 

5600 Fishers Lane, Room 8–103, 

Rockville, Maryland 20857; Telephone: 

(301) 443–2300. This is not a toll-free 

number. 

SUPPLEMENTARY INFORMATION: The 

National Practitioner Data Bank (NPDB) 

is primarily an alert or flagging system 

intended to facilitate a comprehensive 

review of health care practitioners’ 

professional credentials for the purpose 

of protecting the public from unfit 

practitioners. On January 28, 2010, the 

Health Resources and Services 

Administration published a final rule in 

the Federal Register (75 FR 4656) 

designed to implement section 1921 of 

the Social Security Act (herein referred 

to as section 1921). Section 1921 

expands the scope of the NPDB. Section 

1921 requires each state to adopt a 

system of reporting to the Secretary 

certain adverse licensure actions taken 

against health care practitioners and 

health care entities by any authority of 

the state responsible for the licensing of 

such practitioners or entities. It also 

requires each state to report any 

negative action or finding that a state 

licensing authority, a peer review 

organization, or a private accreditation 

entity has finalized against a health care 

practitioner or entity. Practically 

speaking, Section 1921 resulted in, 

among other consequences, the 

inclusion of the vast majority of 

information contained in the Healthcare 

Integrity and Protection Data Bank 

(HIPDB), a companion data bank, in the 

NPDB. 

The HIPDB was created by the Health 

Insurance Portability and 

Accountability Act (HIPAA) of 1996, 

Public Law (Pub. L. 104–191), which 

required the Secretary of HHS, acting 

through the Office of Inspector General 

(OIG) and the United States Attorney 

General, to establish a new health care 

fraud and abuse control program to 

combat health care fraud and abuse. 

Although their purposes are different, 

together the HIPDB and NPDB serve to 

facilitate review of health care 

practitioners’ and entities’ backgrounds. 

The HIPDB is exempt from certain 

provisions of the Privacy Act (see 45 

CFR 5b.11(b)(2)(ii)(F)). In order to 

maintain the exemption for the HIPDB 

investigative materials, which are now 

also available through the NPDB, and 

other expanded information which law 

enforcement agencies can access, it was 

necessary to extend similar Privacy Act 

exemptions for the HIPDB to the NPDB. 

The new routine use that is being added 

for this system pertains to system 

security. It is not specific to the NPDB 

system; it is being added to new, 

existing, and updated SORNs published 

by HHS for other systems that are 

affected by the same security 

requirement. 

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