81 FR 71745 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Practitioner Data Bank Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Certain Other Health Care Entities
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 201 (October 18, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 201 (October 18, 2016)
| Page Range | 71745-71746 | |
| FR Document | 2016-25074 |
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)] [Notices] [Pages 71745-71746] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25074] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Practitioner Data Bank Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Certain Other Health Care Entities AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR must be received no later than November 17, 2016. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: National Practitioner Data Bank (NPDB) Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Health Centers OMB No. 0906-xxxx--NEW. Abstract: The National Practitioner Data Bank (NPDB) plans to collect data from hospitals, medical malpractice payers, health plans, and certain other health care entities \1\ that are subject to NPDB reporting requirements to assist these entities in understanding and meeting their reporting requirements to the NPDB. The NPDB currently collects similar data (OMB No. 0915-0126) from state licensing boards on a regular basis and this information collection request would expand beyond current activities to include hospitals, medical malpractice payers, health plans, and certain other health care entities. --------------------------------------------------------------------------- \1\ Unless otherwise noted, the term ``certain other health care entities'' refers to health centers whose access and reporting obligations are addressed in the NPDB statutory and regulatory requirements for health care entities. In this document, ``health center'' refers to organizations that receive grants under the HRSA Health Center Program as authorized under section 330 of the Public Health Service Act, as amended (referred to as ``grantees'') and FQHC Look-Alike organizations, which meet all the Health Center Program requirements but do not receive Health Center Program grants. It does not refer to FQHCs that are sponsored by tribal or Urban Indian Health Organizations, except for those that receive Health Center Program grants. --------------------------------------------------------------------------- NPDB began operation on September 1, 1990. The statutory authorities establishing and governing the NPDB are Title IV of Public Law (Pub. L.) 99-660, the Health Care Quality Improvement Act of 1986, as amended, Section 5 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100-93, codified as Section 1921 of the Social Security Act, and Section 221(a) of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, codified as Section 1128E of [[Page 71746]] the Social Security Act. Final regulations governing the NPDB are codified at 45 CFR part 60. Responsibility for NPDB implementation and operation resides in the Bureau of Health Workforce, HRSA, HHS. NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information on medical malpractice payments, health-related civil judgments, adverse licensure actions, adverse clinical privileging actions, adverse professional society actions, and Medicare/Medicaid exclusions is collected from, and disseminated to, eligible entities such as licensing boards, hospitals, and certain other health care entities. It is intended that NPDB information should be considered with other relevant information in evaluating a practitioner's credentials. NPDB outlines specific reporting requirements for hospitals, medical malpractice payers, health plans, and certain other health care entities per 45 CFR 60.7, 60.12, 60.14, 60.15, and 60.16. These reporting requirements are further explained in Chapter E of the NPDB e-Guidebook, which can be found at: http://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp. Through a process called Attestation, hospitals, medical malpractice payers, health plans, and certain other health care entities will be required to attest that they understand and have met their responsibility to submit all required reports to the NPDB. The Attestation process will be completely automated through the secure NPDB system (https://www.npdb.hrsa.gov), using both secure email messaging and system notifications to alert entities registered with the NPDB of their responsibility to attest. All entities with reporting requirements and querying access to the NPDB must register with the NPDB before gaining access to the secure NPDB system for all reporting and querying transactions. Although the Attestation process and forms are new, the secure NPDB system currently used by hospitals, medical malpractice payers, health plans, and certain other health care entities to conduct reporting and querying will not change, ensuring that these entities are familiar with the interface needed to complete the Attestation process. NPDB will ask these entities to attest their reporting compliance every 2 years. If the organization is responsible for privileging or credentialing individuals who provide services for other sites, those sites will be included in the Attestation process. The Attestation forms will collect the following information: information regarding sub-sites and entity relationships; contact information for the Attesting Official; and a statement attesting whether or not all required reports have been submitted. Need and Proposed Use of the Information: The NPDB engages in compliance activities to ensure the accuracy and completeness of the information in the NPDB. Through the Attestation process, the NPDB can better determine which hospitals, medical malpractice payers, health plans, and certain other health care entities are meeting the reporting requirements, and which of these entities may require additional outreach and assistance. The biennial Attestation process will strengthen the robustness of the data in the NPDB, improving the accuracy of query responses for entities with access to NPDB reports. Likely Respondents: Hospitals medical malpractice payers, health plans, certain other health care entities, and their representatives. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. Total Estimated Annualized Burden--Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Health Center Form.............. 1,500 1 1,500 1 1,500 Generic Form \1\................ 4,875 1 4,875 1 4,875Hospitals. Medical Malpractice Payers. Health Plans. ------------------------------------------------------------------------------- Total................... \2\ 6,375 .............. 6,375 .............. 6,375 ---------------------------------------------------------------------------------------------------------------- \1\ Hospitals, medical malpractice payers, and health plans will attest using the generic form. \2\ There are approximately 6,800 hospitals, 575 medical malpractice payers, 1,400 health plans, and 2,200 health centers registered with the NPDB. However, the reporting entities may include multiple sites that are registered independently in the system, thereby increasing the total number of respondents. Therefore, we estimate there will be 7,500 respondents for hospitals, 750 respondents for medical malpractice payers, 1,500 respondents for health plans, and 3,000 respondents for health centers for 12,750 total respondents. Given that entities will only be required to complete attestation biennially, these estimates are divided in half for the annualized burden hours. Amy McNulty, Deputy Director, Division of the Executive Secretariat. [FR Doc. 2016-25074 Filed 10-17-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices 71745
The failure of an applicant to file a 2. FDA, draft guidance for industry, of this ICR will be provided to OMB.
timely written notice of participation ‘‘Bioequivalence Studies With OMB will accept further comments from
and request for a hearing, as required by Pharmacokinetic Endpoints for Drugs the public during the review and
§ 314.200, constitutes an election by that Submitted Under an ANDA,’’ December approval period.
2013 (available at http://www.fda.gov/
applicant not to avail itself of the Drugs/GuidanceComplianceRegulatory DATES: Comments on this ICR must be
opportunity for a hearing concerning Information/Guidances/UCM377465). received no later than November 17,
CDER’s proposal to withdraw approval 3. Dighe, S. V. and W. P. Adams, 2016.
of the application and constitutes a ‘‘Bioequivalence: A United States ADDRESSES: Submit your comments,
waiver of any contentions concerning Regulatory Perspective.’’ In: Welling, P. including the ICR Title, to the desk
the legal status of the drug product. FDA G., L. S. Tse, and S. V. Dighe, eds.,
Pharmaceutical Bioequivalence. New
officer for HRSA, either by email to
will then withdraw approval of the OIRA_submission@omb.eop.gov or by
application, and the drug product may York: Marcel Dekker, Inc., pp. 347–380,
1991. fax to 202–395–5806.
not thereafter be lawfully introduced or
4. Swanson, J. M., S. B. Wigal, T. Wigal, et FOR FURTHER INFORMATION CONTACT: To
delivered for introduction into interstate al., ‘‘A Comparison of Once-Daily request a copy of the clearance requests
commerce. Any new drug product Extended-Release Methylphenidate submitted to OMB for review, email the
introduced or delivered for introduction Formulations in Children With HRSA Information Collection Clearance
into interstate commerce without an Attention-Deficit/Hyperactivity Disorder Officer at paperwork@hrsa.gov or call
approved application is subject to in the Laboratory School (The Comacs
(301) 443–1984.
regulatory action at any time. Study),’’ Pediatrics, vol. 113, pp. 206–
216, 2004. SUPPLEMENTARY INFORMATION:
A request for a hearing may not rest
5. Kimko, H., E. Gibiansky, L. Gibiansky, et Information Collection Request Title:
upon mere allegations or denials, but
al., ‘‘Population Pharmacodynamic National Practitioner Data Bank (NPDB)
must present specific facts showing that
Modeling of Various Extended-Release Attestation of Reports by Hospitals,
there is a genuine and substantial issue
Formulations of Methylphenidate in Medical Malpractice Payers, Health
of fact that requires a hearing. If a Children With Attention Deficit Plans, and Health Centers OMB No.
request for a hearing is not complete or Hyperactivity Disorder Via Meta- 0906–xxxx—NEW.
is not supported, the Commissioner of Analysis,’’ Journal of Pharmacokinetics Abstract: The National Practitioner
Food and Drugs will enter summary and Pharmacodynamics, vol. 39(2), pp. Data Bank (NPDB) plans to collect data
judgment against the person who 161–176, 2012.
from hospitals, medical malpractice
requests the hearing, making findings 6. Memorandum to Janet Woodcock, Director,
Center for Drug Evaluation and Research,
payers, health plans, and certain other
and conclusions, and denying a hearing. health care entities 1 that are subject to
All submissions under this notice of in Support of Beginning Approval
Withdrawal Proceedings for ANDA NPDB reporting requirements to assist
opportunity for a hearing must be filed these entities in understanding and
091695 (October 1, 2016, Peters).
in two copies. Except for data and meeting their reporting requirements to
information prohibited from public Dated: October 12, 2016. the NPDB. The NPDB currently collects
disclosure under 21 U.S.C. 331(j) or 18 Janet Woodcock, similar data (OMB No. 0915–0126) from
U.S.C. 1905, the submissions may be Director, Center for Drug Evaluation and state licensing boards on a regular basis
seen in the Division of Dockets Research. and this information collection request
Management (see ADDRESSES) between 9 [FR Doc. 2016–25092 Filed 10–17–16; 8:45 am] would expand beyond current activities
a.m. and 4 p.m., Monday through to include hospitals, medical
BILLING CODE 4164–01–P
Friday, and will be posted to the docket malpractice payers, health plans, and
at http://www.regulations.gov. certain other health care entities.
This notice is issued under section DEPARTMENT OF HEALTH AND NPDB began operation on September
505(e) of the FD&C Act and under the HUMAN SERVICES 1, 1990. The statutory authorities
authority delegated to the Director of establishing and governing the NPDB
CDER by the Commissioner of Food and Health Resources and Services are Title IV of Public Law (Pub. L.) 99–
Drugs. Administration 660, the Health Care Quality
IV. References Improvement Act of 1986, as amended,
Agency Information Collection Section 5 of the Medicare and Medicaid
The following references are on Activities: Submission to OMB for Patient and Program Protection Act of
display in the Division of Dockets Review and Approval; Public Comment 1987, Public Law 100–93, codified as
Management (see ADDRESSES) and are Request; National Practitioner Data Section 1921 of the Social Security Act,
available for viewing by interested Bank Attestation of Reports by and Section 221(a) of the Health
persons between 9 a.m. and 4 p.m., Hospitals, Medical Malpractice Payers, Insurance Portability and
Monday through Friday; they are also Health Plans, and Certain Other Health Accountability Act of 1996, Public Law
available electronically at http:// Care Entities 104–191, codified as Section 1128E of
www.regulations.gov. FDA has verified
the Web site addresses, as of the date AGENCY: Health Resources and Services 1 Unless otherwise noted, the term ‘‘certain other
this document publishes in the Federal Administration (HRSA), Department of health care entities’’ refers to health centers whose
Register, but Web sites are subject to Health and Human Services (HHS). access and reporting obligations are addressed in
change over time. ACTION: Notice. the NPDB statutory and regulatory requirements for
health care entities. In this document, ‘‘health
1. FDA, draft guidance for industry, SUMMARY: In compliance with Section center’’ refers to organizations that receive grants
‘‘Bioequivalence Recommendations for under the HRSA Health Center Program as
Lhorne on DSK30JT082PROD with NOTICES
3507(a)(1)(D) of the Paperwork authorized under section 330 of the Public Health
CONCERTA (Methylphenidate Reduction Act of 1995, HRSA has
Hydrochloride) Extended-Release Service Act, as amended (referred to as ‘‘grantees’’)
Tablets,’’ November 2014 (available at
submitted an Information Collection and FQHC Look-Alike organizations, which meet
Request (ICR) to the Office of all the Health Center Program requirements but do
http://www.fda.gov/downloads/Drugs/ not receive Health Center Program grants. It does
GuidanceCompliance Management and Budget (OMB) for not refer to FQHCs that are sponsored by tribal or
RegulatoryInformation/Guidances/ review and approval. Comments Urban Indian Health Organizations, except for those
UCM320007.pdf). submitted during the first public review that receive Health Center Program grants.
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![71746 Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices
the Social Security Act. Final responsibility to submit all required accuracy and completeness of the
regulations governing the NPDB are reports to the NPDB. The Attestation information in the NPDB. Through the
codified at 45 CFR part 60. process will be completely automated Attestation process, the NPDB can better
Responsibility for NPDB through the secure NPDB system determine which hospitals, medical
implementation and operation resides (https://www.npdb.hrsa.gov), using both malpractice payers, health plans, and
in the Bureau of Health Workforce, secure email messaging and system certain other health care entities are
HRSA, HHS. notifications to alert entities registered meeting the reporting requirements, and
NPDB acts primarily as a flagging with the NPDB of their responsibility to which of these entities may require
system; its principal purpose is to attest. All entities with reporting additional outreach and assistance. The
facilitate comprehensive review of requirements and querying access to the biennial Attestation process will
practitioners’ professional credentials NPDB must register with the NPDB strengthen the robustness of the data in
and background. Information on before gaining access to the secure the NPDB, improving the accuracy of
medical malpractice payments, health- NPDB system for all reporting and
related civil judgments, adverse query responses for entities with access
querying transactions.
licensure actions, adverse clinical Although the Attestation process and to NPDB reports.
privileging actions, adverse professional forms are new, the secure NPDB system Likely Respondents: Hospitals
society actions, and Medicare/Medicaid currently used by hospitals, medical medical malpractice payers, health
exclusions is collected from, and malpractice payers, health plans, and plans, certain other health care entities,
disseminated to, eligible entities such as certain other health care entities to and their representatives.
licensing boards, hospitals, and certain conduct reporting and querying will not Burden Statement: Burden in this
other health care entities. It is intended change, ensuring that these entities are context means the time expended by
that NPDB information should be familiar with the interface needed to persons to generate, maintain, retain,
considered with other relevant complete the Attestation process. NPDB disclose or provide the information
information in evaluating a will ask these entities to attest their
requested. This includes the time
practitioner’s credentials. reporting compliance every 2 years. If
NPDB outlines specific reporting needed to review instructions; to
the organization is responsible for
requirements for hospitals, medical develop, acquire, install and utilize
privileging or credentialing individuals
malpractice payers, health plans, and who provide services for other sites, technology and systems for the purpose
certain other health care entities per 45 those sites will be included in the of collecting, validating and verifying
CFR 60.7, 60.12, 60.14, 60.15, and 60.16. Attestation process. information, processing and
These reporting requirements are further The Attestation forms will collect the maintaining information, and disclosing
explained in Chapter E of the NPDB e- following information: information and providing information; to train
Guidebook, which can be found at: regarding sub-sites and entity personnel and to be able to respond to
http://www.npdb.hrsa.gov/resources/ relationships; contact information for a collection of information; to search
aboutGuidebooks.jsp. the Attesting Official; and a statement data sources; to complete and review
Through a process called Attestation, attesting whether or not all required the collection of information; and to
hospitals, medical malpractice payers, reports have been submitted. transmit or otherwise disclose the
health plans, and certain other health Need and Proposed Use of the information. The total annual burden
care entities will be required to attest Information: The NPDB engages in hours estimated for this ICR are
that they understand and have met their compliance activities to ensure the summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Health Center Form ............................................................. 1,500 1 1,500 1 1,500
Generic Form 1 ..................................................................... 4,875 1 4,875 1 4,875
• Hospitals.
• Medical Malpractice Payers.
• Health Plans.
Total ....................................................................... 2 6,375 ........................ 6,375 ........................ 6,375
1 Hospitals,medical malpractice payers, and health plans will attest using the generic form.
2 There are approximately 6,800 hospitals, 575 medical malpractice payers, 1,400 health plans, and 2,200 health centers registered with the
NPDB. However, the reporting entities may include multiple sites that are registered independently in the system, thereby increasing the total
number of respondents. Therefore, we estimate there will be 7,500 respondents for hospitals, 750 respondents for medical malpractice payers,
1,500 respondents for health plans, and 3,000 respondents for health centers for 12,750 total respondents. Given that entities will only be re-
quired to complete attestation biennially, these estimates are divided in half for the annualized burden hours.
Amy McNulty, DEPARTMENT OF HEALTH AND of Performance Review Members be
Deputy Director, Division of the Executive HUMAN SERVICES published in the Federal Register.
Lhorne on DSK30JT082PROD with NOTICES
Secretariat. The following persons may be named
[FR Doc. 2016–25074 Filed 10–17–16; 8:45 am] Performance Review Board Members to serve on the Performance Review
BILLING CODE 4165–15–P Boards or Panels, which oversee the
Title 5, U.S.C. 4314(c) (4) of the Civil
evaluation of performance appraisals of
Service Reform Act of 1978, Public Law
Senior Executive Service members of
95–454, requires that the appointment
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Document Created: 2016-10-17 23:52:42
Document Modified: 2016-10-17 23:52:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR must be received no later than November 17, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 71745 |
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