82 FR 42821 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0915-0126-Revision
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 175 (September 12, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 175 (September 12, 2017)
| Page Range | 42821-42823 | |
| FR Document | 2017-19252 |
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)] [Notices] [Pages 42821-42823] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19252] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners--45 CFR Part 60 Regulations and Forms, OMB No. 0915-0126--Revision AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR must be received no later than November 13, 2017. ADDRESSES: Submit your comments to [email protected] or mail to the HRSA Information Collection Clearance Officer, 14N39, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners--45 CFR part 60 Regulations and Forms, OMB No. 0915- 0126--Revision. Abstract: This is a request for a revision of OMB approval of the information collection contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Administrative forms are also included to aid in monitoring compliance with Federal reporting and querying requirements. Responsibility for NPDB implementation and operation resides in HRSA's Bureau of Health Workforce. The intent of the NPDB is to improve the quality of health care by encouraging hospitals, State licensing boards, professional societies, and other entities providing health care services to identify and discipline those who engage in unprofessional behavior, and to restrict the ability of incompetent health care practitioners, providers, or suppliers to move from State to State without disclosure of previous damaging or incompetent performance. It also serves as a fraud and abuse clearinghouse for the reporting and disclosing of certain final adverse actions (excluding settlements in which no findings of liability have been made) taken against health care practitioners, providers, or suppliers by health plans, Federal agencies, and State agencies. The reporting forms, request for information forms (query forms), and administrative forms (used to monitor compliance) are accessed, completed, and submitted to the NPDB [[Page 42822]] electronically through the NPDB Web site at https://www.npdb.hrsa.gov/. All reporting and querying is performed through the secure portal of this Web site. This revision proposes changes to eliminate redundant and unnecessary forms, improve user error recovery, and improve overall data integrity. There is no change to the average burden per response. The total estimated number of respondents has increased from 5 million in 2015 to over 6 million in 2017, primarily attributable to increases in use of the ``One-Time Query for an Individual'' and ``Continuous Query'' forms. The increase in total respondents has resulted in an estimated increase of approximately 47,000 total burden hours. Need and Proposed Use of the Information: The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information is collected from, and disseminated to, eligible entities (entities that are entitled to query and/or report to the NPDB as authorized in Title 45 CFR part 60 of the Code of Federal Regulations) on the following: (1) Medical malpractice payments, (2) licensure actions taken by Boards of Medical Examiners, (3) State licensure and certification actions, (4) Federal licensure and certification actions, (5) negative actions or findings taken by peer review organizations or private accreditation entities, (6) adverse actions taken against clinical privileges, (7) Federal or State criminal convictions related to the delivery of a health care item or service, (8) civil judgments related to the delivery of a health care item or service, (9) exclusions from participation in Federal or State health care programs, and (10) other adjudicated actions or decisions. It is intended that NPDB information should be considered with other relevant information in evaluating credentials of health care practitioners, providers, and suppliers. Likely Respondents: Eligible entities or individuals that are entitled to query and/or report to the NPDB as authorized in regulations found at 45 CFR part 60. 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 ---------------------------------------------------------------------------------------------------------------- Number of Average burden Total burden Form name Number of responses per Total per response hours (rounded respondents respondent responses (in hours) up) ---------------------------------------------------------------------------------------------------------------- Accreditation.................. 10 1 10 .75 8 Civil Judgment................. 10 1 10 .75 8 Criminal Conviction (Guilty 1,140 1 1,140 .75 855 Plea or Trial) (manual)....... Criminal Conviction (Guilty 688 1 688 .0003 1 Plea or Trial) (automated).... DEA/Federal Licensure.......... 698 1 698 .75 524 Deferred Conviction or Pre- 54 1 54 .75 41 Trial Diversion............... Exclusion/Debarment (manual)... 1,624 1 1,624 .75 1,218 Exclusion/Debarment (automated) 3,180 1 3,180 .0003 1 Government Administrative...... 2,062 1 2,062 .75 1,547 Health Plan Action............. 335 1 335 .75 252 Injunction..................... 10 1 10 .75 8 Medical Malpractice Payment 11,993 1 11,993 .75 8,995 (manual)...................... Medical Malpractice Payment 242 1 242 .0003 1 (automated)................... Nolo Contendere (No Contest) 85 1 85 .75 64 Plea.......................... Peer Review Organization....... 10 1 10 .75 8 Professional Society........... 49 1 49 .75 37 State Licensure (manual)....... 19,160 1 19,160 .75 14,370 State Licensure (automated).... 25,980 1 25,980 .0003 8 Title IV Clinical Privileges 698 1 698 .75 524 Actions....................... Correction, Revision to Action, 11,114 1 11,114 .25 2,779 Correction of Revision to Action, Void, Notice of Appeal (manual)...................... Correction, Revision to Action, 17,966 1 17,966 .0003 6 Correction of Revision to Action, Void, Notice of Appeal (automated)................... One-Time Query for an 2,054,381 1 2,054,381 .08 164,351 Individual (manual)........... One-Time Query for an 2,813,341 1 2,813,341 .0003 844 Individual (automated)........ One-Time Query for an 39,695 1 39,695 .08 3,176 Organization (manual)......... One-Time Query for an 10,201 1 10,201 .0003 4 Organization (automated)...... Continuous Query (manual)...... 643,860 1 643,860 .08 51,509 Continuous Query (automated)... 226,838 1 226,838 .0003 69 Self-Query on an Individual.... 131,481 1 131,481 .42 55,223 Self-Query on an Organization.. 1,545 1 1,545 .42 649 Entity Registration (Initial).. 1,073 1 1,073 1 1,073 Entity Registration (Renewal & 14,060 1 14,060 .25 3,515 Update)....................... Agent Registration (Initial)... 85 1 85 1 85 Agent Registration (Renewal & 278 1 278 .08 23 Update)....................... Entity Profile................. 9,000 1 9,000 .25 2,250 Licensing Board Attestation.... 301 1 301 1 301 Licensing Board Data Request... 146 1 146 10.5 1,533 Reconciling Missing Actions.... 7,981 1 7,981 0.8 6,385 Corrective Action Plan......... 10 1 10 .08 1 [[Page 42823]] Missing Report Form............ 29 1 29 .08 3 Subject Statement and Dispute.. 3,547 1 3,547 .75 2,661 Request for Dispute Resolution. 99 1 99 8 792 Electronic Transfer of Funds 654 1 654 .08 53 (EFT) Authorization........... Authorized Agent Designation... 213 1 213 .25 54 Account Discrepancy............ 10 1 10 .25 3 New Administrator Request...... 3,016 1 3,016 .08 242 Query Credit Purchase.......... 789 1 789 .08 64 Educational Request............ 10 1 10 .08 1 Account Balance Transfer....... 10 1 10 .08 1 -------------------------------------------------------------------------------- Total...................... 6,059,761 .............. 6,059,761 ............... 326,120 ---------------------------------------------------------------------------------------------------------------- HRSA specifically requests 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. Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2017-19252 Filed 9-11-17; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42821
Studies.’’ It does not establish any rights www.regulations.gov. FDA has verified DATES: Comments on this ICR must be
for any person and is not binding on the Web site addresses, as of the date received no later than November 13,
FDA or the public. You can use an this document publishes in the Federal 2017.
alternative approach if it satisfies the Register, but Web sites are subject to ADDRESSES: Submit your comments to
requirements of the applicable statutes change over time. paperwork@hrsa.gov or mail to the
and regulations. This guidance is not 1. FDA Report: Collection, Analysis, and HRSA Information Collection Clearance
subject to Executive Order 12866. Availability of Demographic Subgroup Officer, 14N39, 5600 Fishers Lane,
III. Electronic Access Data for FDA-Approved Medical Rockville, MD 20857.
Products, issued August 2013, required FOR FURTHER INFORMATION CONTACT: To
Persons interested in obtaining a copy under FDASIA section 907, available at
of the guidance may do so by request more information on the
http://www.fda.gov/downloads/
downloading an electronic copy from RegulatoryInformation/Legislation/
proposed project or to obtain a copy of
the internet. A search capability for all SignificantAmendmentstotheFDCAct/ the data collection plans and draft
Center for Devices and Radiological FDASIA/UCM365544.pdf. instruments, email paperwork@hrsa.gov
Health guidance documents is available 2. FDA’s Action Plan to Enhance the or call the HRSA Information Collection
at https://www.fda.gov/MedicalDevices/ Collection and Availability of Clearance Officer at (301) 443–1984.
DeviceRegulationandGuidance/ Demographic Subgroup Data (August, SUPPLEMENTARY INFORMATION: When
GuidanceDocuments/default.htm. 2014), available at https://www.fda.gov/ submitting comments or requesting
Guidance documents are also available downloads/RegulatoryInformation/ information, please include the
Legislation/ information request collection title for
at https://www.fda.gov/BiologicsBlood
SignificantAmendmentstotheFDCAct/ reference, in compliance with Section
Vaccines/GuidanceCompliance FDASIA/UCM410474.pdf.
RegulatoryInformation/default.htm or 3. FDA’s guidance entitled ‘‘Evaluation of
3506(c)(2)(A) of the Paperwork
https://www.regulations.gov. Persons Sex-Specific Data in Medical Device Reduction Act of 1995.
unable to download an electronic copy Clinical Studies’’ (August 22, 2014), Information Collection Request Title:
of ‘‘Evaluation and Reporting of Age, available at https://www.fda.gov/ National Practitioner Data Bank for
Race, and Ethnicity Data in Medical downloads/MedicalDevices/Device Adverse Information on Physicians and
Device Clinical Studies’’ may send an RegulationandGuidance/Guidance Other Health Care Practitioners—45
email request to CDRH-Guidance@ Documents/UCM283707.pdf. CFR part 60 Regulations and Forms,
fda.hhs.gov to receive an electronic Dated: September 7, 2017. OMB No. 0915–0126—Revision.
copy of the document. Please use the Abstract: This is a request for a
Leslie Kux,
document number 1500626 to identify revision of OMB approval of the
Associate Commissioner for Policy. information collection contained in
the guidance you are requesting.
[FR Doc. 2017–19259 Filed 9–11–17; 8:45 am] regulations found at 45 CFR part 60
IV. Paperwork Reduction Act of 1995 BILLING CODE 4164–01–P governing the National Practitioner Data
This guidance refers to previously Bank (NPDB) and the forms to be used
approved collections of information in registering with, reporting
found in FDA regulations. These DEPARTMENT OF HEALTH AND information to, and requesting
collections of information are subject to HUMAN SERVICES information from the NPDB.
review by the Office of Management and Administrative forms are also included
Health Resources and Services
Budget (OMB) under the Paperwork to aid in monitoring compliance with
Administration
Reduction Act of 1995 (44 U.S.C. 3501– Federal reporting and querying
3520). These collections of information Agency Information Collection requirements. Responsibility for NPDB
in 21 CFR part 812 have been approved Activities: Proposed Collection: Public implementation and operation resides
under OMB control number 0910–0078; Comment Request; Information in HRSA’s Bureau of Health Workforce.
the collections of information in 21 CFR Collection Request Title: National The intent of the NPDB is to improve
part 807, subpart E, have been approved Practitioner Data Bank for Adverse the quality of health care by
under OMB control number 0910–0120; Information on Physicians and Other encouraging hospitals, State licensing
the collections of information in 21 CFR Health Care Practitioners—45 CFR Part boards, professional societies, and other
part 814, subparts A through E, have 60 Regulations and Forms, OMB No. entities providing health care services to
been approved under OMB control 0915–0126—Revision identify and discipline those who
number 0910–0231; the collections of engage in unprofessional behavior, and
information in 21 CFR part 814, subpart AGENCY: Health Resources and Services to restrict the ability of incompetent
H, have been approved under OMB Administration (HRSA), Department of health care practitioners, providers, or
control number 0910–0332; the Health and Human Services (HHS). suppliers to move from State to State
collections of information in 21 CFR without disclosure of previous
part 822 have been approved under ACTION: Notice. damaging or incompetent performance.
OMB control number 0910–0449; and It also serves as a fraud and abuse
the collections of information in 21 CFR SUMMARY: In compliance with the clearinghouse for the reporting and
part 801 have been approved under requirement for opportunity for public disclosing of certain final adverse
OMB control number 0910–0485. comment on proposed data collection actions (excluding settlements in which
projects of the Paperwork Reduction Act no findings of liability have been made)
pmangrum on DSK3GDR082PROD with NOTICES1
V. References of 1995, HRSA announces plans to taken against health care practitioners,
The following references are on submit an Information Collection providers, or suppliers by health plans,
display in the Dockets Management Request (ICR), described below, to the Federal agencies, and State agencies.
Staff office (see ADDRESSES) and are Office of Management and Budget The reporting forms, request for
available for viewing by interested (OMB). Prior to submitting the ICR to information forms (query forms), and
persons between 9 a.m. and 4 p.m., OMB, HRSA seeks comments from the administrative forms (used to monitor
Monday through Friday; they are also public regarding the burden estimate, compliance) are accessed, completed,
available electronically at https:// below, or any other aspect of the ICR. and submitted to the NPDB
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![Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42823
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Average burden Total burden
Number of Total
Form name responses per per response hours
respondents responses
respondent (in hours) (rounded up)
Missing Report Form ......................................................... 29 1 29 .08 3
Subject Statement and Dispute ......................................... 3,547 1 3,547 .75 2,661
Request for Dispute Resolution ......................................... 99 1 99 8 792
Electronic Transfer of Funds (EFT) Authorization ............. 654 1 654 .08 53
Authorized Agent Designation ........................................... 213 1 213 .25 54
Account Discrepancy ......................................................... 10 1 10 .25 3
New Administrator Request ............................................... 3,016 1 3,016 .08 242
Query Credit Purchase ...................................................... 789 1 789 .08 64
Educational Request .......................................................... 10 1 10 .08 1
Account Balance Transfer ................................................. 10 1 10 .08 1
Total ............................................................................ 6,059,761 ........................ 6,059,761 .......................... 326,120
HRSA specifically requests comments Date: October 2, 2017. Transfer and Development Office of
on (1) the necessity and utility of the Time: 8:00 a.m. to 6:00 p.m. Technology Transfer, 31 Center Drive,
proposed information collection for the Agenda: To review and evaluate grant Room 4A29, MSC2479, Bethesda, MD
proper performance of the agency’s applications. 20892–2479; telephone: 301–402–5579.
Place: Residence Inn Bethesda Downtown,
functions, (2) the accuracy of the 7335 Wisconsin Ave., Bethesda, MD 20814.
A signed Confidential Disclosure
estimated burden, (3) ways to enhance Contact Person: Cathy J. Wedeen, Ph.D., Agreement may be required to receive
the quality, utility, and clarity of the Scientific Review Officer, Division of copies of the patent applications.
information to be collected, and (4) the Scientific Review, OD, Eunice Kennedy SUPPLEMENTARY INFORMATION: The
use of automated collection techniques Shriver National Institute of Child Health inventions listed below are owned by an
or other forms of information and Human Development, NIH, DHHS, 6710 agency of the U.S. Government and are
technology to minimize the information B Rockledge Drive, Bethesda, Maryland available for licensing in the U.S. in
collection burden. 20892, 301–435–6878, wedeenc@ accordance with 35 U.S.C. 209 and 37
mail.nih.gov.
CFR part 404 to achieve expeditious
Amy McNulty, (Catalogue of Federal Domestic Assistance commercialization of results of
Acting Director, Division of the Executive Program Nos. 93.864, Population Research; federally-funded research and
Secretariat. 93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
development. Foreign patent
[FR Doc. 2017–19252 Filed 9–11–17; 8:45 am]
Research; 93.209, Contraception and applications are filed on selected
BILLING CODE 4165–15–P inventions to extend market coverage
Infertility Loan Repayment Program, National
Institutes of Health, HHS) for companies and may also be available
for licensing. A description of the
DEPARTMENT OF HEALTH AND Dated: September 6, 2017.
technology available for licensing
HUMAN SERVICES Michelle Trout,
follows.
Program Analyst, Office of Federal Advisory
National Institutes of Health Committee Policy. Evans Blue Dye Derivatives for Serum
[FR Doc. 2017–19232 Filed 9–11–17; 8:45 am] Albumin Labeling
Eunice Kennedy Shriver National
Institute of Child Health and Human BILLING CODE 4140–01–P Description of Technology: The
Development; Notice of Closed invention is an imaging agent and
Meeting method of its use for imaging blood
DEPARTMENT OF HEALTH AND pools and the lymphatic system. The
Pursuant to section 10(d) of the HUMAN SERVICES imaging agent binds with high affinity
Federal Advisory Committee Act, as to serum albumin, the most abundant
amended, notice is hereby given of the National Institutes of Health serum protein, and can be tagged with
following meeting. Government-Owned Inventions; several isotopes making it suitable for
The meeting will be closed to the Availability for Licensing magnetic resonance imaging or positron
public in accordance with the emission tomographic imaging. To date,
provisions set forth in sections AGENCY: National Institutes of Health, only very few blood-pool tracers have
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HHS. been introduced for positron emission
as amended. The grant applications and ACTION: Notice. tomography. The existing ones have
the discussions could disclose short half-lives (20.4 min for 11C and
confidential trade secrets or commercial SUMMARY: Government owned 2.05 min for 15O) and thus can only be
property such as patentable material, intellectual property covering imaging used in centers with an in-house
and personal information concerning agents with improved renal clearance cyclotron. Compared with these
pmangrum on DSK3GDR082PROD with NOTICES1
individuals associated with the grant available for licensing and radiometals, 18F has the advantages of
applications, the disclosure of which commercialization. being a pure position emitter with ideal
would constitute a clearly unwarranted FOR FURTHER INFORMATION CONTACT: half-life. It is the dominant radioisotope
invasion of personal privacy. Licensing information and copies of the used for PET imaging for both clinical
Name of Committee: National Institute of patent applications listed below may be applications and preclinical
Child Health and Human Development Initial obtained by emailing the indicated investigations. Evans blue dye has been
Review Group; Developmental Biology licensing contact at the National Heart, an important tool in many physiological
Subcommittee. Lung, and Blood, Office of Technology and clinical investigations because of its
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Document Created: 2018-10-24 14:15:14
Document Modified: 2018-10-24 14:15:14
| 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 13, 2017. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 82 FR 42821 |
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