Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 7481-7483 [2015-02658]

Download as PDF Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices 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 February 24, 2015. 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 Stephanie L. Begansky 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). Dated: February 5, 2015. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2015–02670 Filed 2–9–15; 8:45 am] BILLING CODE 4164–01–P 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 Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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 rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:20 Feb 09, 2015 Jkt 235001 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 should be received no later than March 12, 2015. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov 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 paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: 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 the Bureau of Health Workforce, Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 7481 administrative forms (used to monitor compliance) are accessed, completed, and submitted to the NPDB electronically through the NPDB Web site at http://www.npdb.hrsa.gov/. All reporting and querying is performed through this secure Web site. 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 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 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. E:\FR\FM\10FEN1.SGM 10FEN1 7482 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Regulation citation Form name § 60.6: Reporting errors, omissions, revisions, or whether an action is on appeal. Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (manual). Correction, Revision to Action, Correction of Revision to Action, Void, Notice of Appeal (automated). Medical Malpractice Payment (manual). Medical Malpractice Payment (automated). State Licensure (manual) § 60.7: Reporting medical malpractice payments. § 60.8: Reporting licensure actions taken by Boards of Medical Examiners & § 60.9: Reporting licensure and certification actions taken by States. § 60.10: Reporting Federal licensure and certification actions. § 60.11: Reporting negative actions or findings taken by peer review organizations or private accreditation entities. § 60.12: Reporting adverse actions taken against clinical privileges. § 60.13: Reporting Federal or State criminal convictions related to the delivery of a health care item or service. § 60.14: Reporting civil judgments related to the delivery of a health care item or service. § 60.15: Reporting exclusions from participation in Federal or State health care programs. rljohnson on DSK3VPTVN1PROD with NOTICES § 60.18 Requesting Information from the NPDB. VerDate Sep<11>2014 Responses per respondent Average burden per response (in hours) Total responses Total burden hours 20,482 1 20,482 .25 17,185 1 17,185 .0003 12,613 1 12,613 .75 250 1 250 16,770 1 16,770 .75 State Licensure (automated). DEA/Federal Licensure .... 17,422 1 17,422 .0003 114 1 114 .75 86 Peer Review Organization 10 1 10 .75 8 Accreditation ..................... Title IV Clinical Privileges Actions. 12 671 1 1 12 671 .75 .75 9 503 Professional Society ......... Criminal Conviction (Guilty Plea or Trial) (manual). 50 1,308 1 1 50 1,308 .75 .75 38 981 Criminal Conviction (Guilty Plea or Trial) (automated). Deferred Conviction or Pre-Trial Diversion. Nolo Contendere (No Contest) Plea. Injunction .......................... Civil Judgment .................. 937 1 937 50 1 50 .75 38 80 1 80 .75 60 10 14 1 1 10 14 .75 .75 8 11 Exclusion/Debarment (manual). 1,185 1 1,185 .75 889 Exclusion/Debarment (automated). Health Plan Action ............ One Time Query for an Individual (manual). One Time Query for an Individual (automated). One Time Query for an Organization (manual). One Time Query for an Organization (automated). Self-Query on an Individual. 5,094 1 5,094 .0003 524 1,980,825 1 1 524 1,980,825 .75 .08 2,163,208 1 2,163,208 .0003 39,920 1 39,920 2,266 1 2,266 77,318 1 77,318 15:20 Feb 09, 2015 Jkt 235001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\10FEN1.SGM 10FEN1 5,121 5 9,460 .0003 .1 12,578 5 .0003 .08 .0003 .42 .3 2 393 158,466 649 3,194 1 30,201 7483 Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued Regulation citation § 60.21: How to dispute the accuracy of NPDB information. Administrative ................... Total ........................... Self-Query on an Organization. Continuous Query (manual). Continuous Query (automated). Subject Statement and Dispute. Request for Dispute Resolution. Non-Hospital Entity Registration (Initial). Non-Hospital Entity Registration (Renewal). Hospital Registration (Initial). Hospital Registration (Renewal). Licensing Board Data Request. Reporting Entity Discrepancy Letter. Licensing Board Attestation. Corrective Action Plan ...... Reconciling Missing Actions. Agent Registration (Initial) Agent Registration (Renewal). Electronic Transfer of Funds (EFT) Authorization. Authorized Agent Designation. Account Discrepancy ........ ........................................... Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–02658 Filed 2–9–15; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA–NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 Number of respondents Form name 15:20 Feb 09, 2015 Jkt 235001 Responses per respondent Frm 00082 Total burden hours 427 1 427 508,203 1 508,203 .08 121,718 1 121,718 .0003 3,501 1 3,501 94 1 94 8 752 524 1 524 1 524 6,383 1 6,383 37 1 37 3,198 1 3,198 140 1 140 10.5 1,470 389 1 389 4 1556 354 1 354 1 354 10 2,176 1 1 10 2,176 .08 0.8 1 174 30 194 1 1 30 194 1 427 566 1 788 .75 .25 40,656 37 2,626 1,596 1 37 .25 800 .08 30 16 566 .08 45 1 788 .25 197 41 1 41 .25 10 5,009,324 ........................ 5,009,324 the Federal Register on December 4, 2014 (Vol. 79, No. 233, pages 72003–4) and allowed 60 days for public comment. A total of five public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. PO 00000 Average burden per response (in hours) Total responses Fmt 4703 Sfmt 4703 1 .......................... 275,689 Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Bradford W. Hesse, Ph.D., Health Communication and Informatics Research Branch, 9609 Medical Center Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free number 240–276–6721 or Email your request, including your address, to hesseb@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Health Information National Trends Survey (HINTS) 0925–0538, Reinstatement with Change, National Cancer Institute (NCI), National Institutes of Health (NIH). FOR FURTHER INFORMATION CONTACT: E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7481-7483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02658]


-----------------------------------------------------------------------

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

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(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 should be received no later than March 12, 
2015.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to 
OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION:
    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 the Bureau of Health Workforce, Health Resources and 
Services Administration (HRSA), Department of Health and Human Services 
(HHS).
    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 electronically through the NPDB 
Web site at http://www.npdb.hrsa.gov/. All reporting and querying is 
performed through this secure Web site.
    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 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 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.

[[Page 7482]]



                                                        Total Estimated Annualized Burden--Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Average burden
           Regulation citation                       Form name              Number of     Responses per       Total       per response     Total burden
                                                                           respondents     respondent       responses      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   60.6: Reporting errors, omissions,  Correction, Revision to               20,482               1          20,482           .25            5,121
 revisions, or whether an action is on      Action, Correction of
 appeal.                                    Revision to Action, Void,
                                            Notice of Appeal (manual).
                                           Correction, Revision to               17,185               1          17,185           .0003              5
                                            Action, Correction of
                                            Revision to Action, Void,
                                            Notice of Appeal
                                            (automated).
Sec.   60.7: Reporting medical             Medical Malpractice Payment           12,613               1          12,613           .75            9,460
 malpractice payments.                      (manual).
                                           Medical Malpractice Payment              250               1             250           .0003               .1
                                            (automated).
Sec.   60.8: Reporting licensure actions   State Licensure (manual)....          16,770               1          16,770           .75           12,578
 taken by Boards of Medical Examiners &
 Sec.   60.9: Reporting licensure and
 certification actions taken by States.
                                           State Licensure (automated).          17,422               1          17,422           .0003              5
Sec.   60.10: Reporting Federal licensure  DEA/Federal Licensure.......             114               1             114           .75               86
 and certification actions.
Sec.   60.11: Reporting negative actions   Peer Review Organization....              10               1              10           .75                8
 or findings taken by peer review
 organizations or private accreditation
 entities.
                                           Accreditation...............              12               1              12           .75                9
Sec.   60.12: Reporting adverse actions    Title IV Clinical Privileges             671               1             671           .75              503
 taken against clinical privileges.         Actions.
                                           Professional Society........              50               1              50           .75               38
Sec.   60.13: Reporting Federal or State   Criminal Conviction (Guilty            1,308               1           1,308           .75              981
 criminal convictions related to the        Plea or Trial) (manual).
 delivery of a health care item or
 service.
                                           Criminal Conviction (Guilty              937               1             937           .0003               .3
                                            Plea or Trial) (automated).
                                           Deferred Conviction or Pre-               50               1              50           .75               38
                                            Trial Diversion.
                                           Nolo Contendere (No Contest)              80               1              80           .75               60
                                            Plea.
                                           Injunction..................              10               1              10           .75                8
Sec.   60.14: Reporting civil judgments    Civil Judgment..............              14               1              14           .75               11
 related to the delivery of a health care
 item or service.
Sec.   60.15: Reporting exclusions from    Exclusion/Debarment (manual)           1,185               1           1,185           .75              889
 participation in Federal or State health
 care programs.
                                           Exclusion/Debarment                    5,094               1           5,094           .0003              2
                                            (automated).
                                           Health Plan Action..........             524               1             524           .75              393
Sec.   60.18 Requesting Information from   One Time Query for an              1,980,825               1       1,980,825           .08          158,466
 the NPDB.                                  Individual (manual).
                                           One Time Query for an              2,163,208               1       2,163,208           .0003            649
                                            Individual (automated).
                                           One Time Query for an                 39,920               1          39,920           .08            3,194
                                            Organization (manual).
                                           One Time Query for an                  2,266               1           2,266           .0003              1
                                            Organization (automated).
                                           Self-Query on an Individual.          77,318               1          77,318           .42           30,201

[[Page 7483]]

 
                                           Self-Query on an                         427               1             427          1                 427
                                            Organization.
                                           Continuous Query (manual)...         508,203               1         508,203           .08           40,656
                                           Continuous Query (automated)         121,718               1         121,718           .0003             37
Sec.   60.21: How to dispute the accuracy  Subject Statement and                  3,501               1           3,501           .75            2,626
 of NPDB information.                       Dispute.
                                           Request for Dispute                       94               1              94          8                 752
                                            Resolution.
Administrative...........................  Non-Hospital Entity                      524               1             524          1                 524
                                            Registration (Initial).
                                           Non-Hospital Entity                    6,383               1           6,383           .25            1,596
                                            Registration (Renewal).
                                           Hospital Registration                     37               1              37          1                  37
                                            (Initial).
                                           Hospital Registration                  3,198               1           3,198           .25              800
                                            (Renewal).
                                           Licensing Board Data Request             140               1             140         10.5             1,470
                                           Reporting Entity Discrepancy             389               1             389          4                1556
                                            Letter.
                                           Licensing Board Attestation.             354               1             354          1                 354
                                           Corrective Action Plan......              10               1              10           .08                1
                                           Reconciling Missing Actions.           2,176               1           2,176          0.8               174
                                           Agent Registration (Initial)              30               1              30          1                  30
                                           Agent Registration (Renewal)             194               1             194           .08               16
                                           Electronic Transfer of Funds             566               1             566           .08               45
                                            (EFT) Authorization.
                                           Authorized Agent Designation             788               1             788           .25              197
                                           Account Discrepancy.........              41               1              41           .25               10
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ............................       5,009,324  ..............       5,009,324  ..............        275,689
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-02658 Filed 2-9-15; 8:45 am]
BILLING CODE 4165-15-P