81 FR 3806 - Request for Public Comment: 60 Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Federal Register Volume 81, Issue 14 (January 22, 2016)
Indian Health Service
Federal Register Volume 81, Issue 14 (January 22, 2016)
| Page Range | 3806-3807 | |
| FR Document | 2016-01208 |
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)] [Notices] [Pages 3806-3807] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01208] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 60 Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule AGENCY: Indian Health Service, HHS. ACTION: Notice and request for comments. Request for extension of approval. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 and 164),'' Office of Management and Budget (OMB) Control Number 0917-0030. DATES: Comment Due Date: March 22, 2016. Your comments regarding this information collection are best assured of having full effect if received within 60 days of the date of this publication. ADDRESSES: Send your written comments, requests for more information on the collection, or requests to obtain a copy of the data collection instrument and instructions to Tamara Clay by one of the following methods:Mail: Tamara Clay, Information Collection Clearance Officer, Indian Health Service, Office of Management Services, Division of Regulatory Affairs, 5600 Fishers Lane, Mail Stop 09E70, Rockville, MD 20857. Phone: 301-443-4750. Email: [email protected]. Fax: 301-443-2316. SUPPLEMENTARY INFORMATION: This previously approved information collection project was last published in the Federal Register (78 FR 2412) on January 11, 2013, and allowed 30 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit the collection, which expires April 30, 2016, to OMB for approval of an extension, and to solicit comments on specific aspects of the information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2016-1). Title of Collection: 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 and 164). Type of Information Collection Request: Extension of the currently approved information collection, 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 and 164). Form(s): IHS-810, IHS-912-1, IHS-912-2, IHS-913, and IHS-917. Need and Use of Information Collection: This collection of information is made necessary by the Department of Health and Human Services Rule entitled ``Standards for Privacy of Individually Identifiable Health Information'' (Privacy Rule) (45 CFR parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996, creates national standards to protect individual's personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.522, 164.526 and 164.528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will continue to use the following data collection instruments to meet the [[Page 3807]] information collection requirements contained in the Rule. 45 CFR 164.508: This provision requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information for other than for treatment, payment and healthcare operations. Under the provision individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The form IHS-810 ``Authorization for Use or Disclosure of Protected Health Information'' is used to document an individual's authorization to use or disclose their protected health information. 45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction. The form IHS-912-1 ``Request for Restrictions(s)'' is used to document an individual's request for restriction of their protected health information, and whether IHS agreed or disagreed with the restriction. Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction if the individual agrees to or requests the termination in writing. The form IHS-912-2 ``Request for Revocation of Restriction(s)'' is used to document the agency or individual request to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. 45 CFR 164.528 and 45 CFR 5b.9(c): This provision requires covered entities to permit individuals to request that the covered entity provide an accounting of disclosures of protected health information made by the covered entity. The form IHS-913 ``Request for an Accounting of Disclosures'' is used to document an individual's request for an accounting of disclosures of their protected health information and the agency's handling of the request. 45 CFR 164.526: This provision requires covered entities to permit an individual to request that the covered entity amend protected health information. If the covered entity accepts the requested amendment, in whole or in part, the covered entity must inform the individual that the amendment is accepted. If the covered entity denies the requested amendment, in whole or in part, the covered entity must provide the individual with a written denial. The form IHS-917 ``Request for Correction/Amendment of Protected Health Information'' will be used to document an individual's request to amend their protected health information and the agency's decision to accept or deny the request. Completed forms used in this collection of information are filed in the IHS medical, health and billing record, a Privacy Act System of Records Notice. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides for this information collection: Types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hour(s). ---------------------------------------------------------------------------------------------------------------- Number of Average burden Data collection instrument Number of responses per hour per Total annual respondents respondent response * burden hours ---------------------------------------------------------------------------------------------------------------- Authorization for Use or Disclosure of Protected 210,954 1 10/60 35,159 Health Information (OMB Form No. 0917-0030, IHS- 810)........................................... Request for Restriction(s) (OMB Form No. 0917- 214 1 10/60 36 0030, IHS-912-1)............................... Request for Revocation of Restriction(s) (OMB 3 1 10/60 .5 Form No. 0917-0030, IHS-912-2)................. Request for Accounting of Disclosures (OMB Form 39 1 10/60 6.5 No. 0917-0030, IHS-913)........................ Request for Correction/Amendment of Protected 54 1 10/60 9 Health Information (OMB Form No. 0917-0030, IHS- 917)........................................... --------------------------------------------------------------- Total Annual Burden......................... 211,264 .............. .............. 35,211 ---------------------------------------------------------------------------------------------------------------- * For ease of understanding, burden hours are provided in actual minutes. The total estimated burden for this collection of information is 35,211 hours. There are no capital costs, operating costs and/or maintenance costs to respondents. Requests for Comments: Your written comments and/or suggestions are invited on one or more of the following points: (a) Whether the information collection activity is necessary to carry out an agency function; (b) whether the agency processes the information collected in a useful and timely fashion; (c) the accuracy of the public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information); (d) whether the methodology and assumptions used to determine the estimates are logical; (e) ways to enhance the quality, utility, and clarity of the information being collected; and (f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Dated: January 13, 2016. Robert G. McSwain, Principal Deputy Director, Indian Health Service. [FR Doc. 2016-01208 Filed 1-21-16; 8:45 am] BILLING CODE 4165-16-P
![3806 Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Notices
Drug Administration, 10903 New practices, and quality systems information collection are best assured
Hampshire Avenue, Bldg. 31, Rm. 2417, implementation. Almost all non-Federal of having full effect if received within
Silver Spring, MD 20993–0002, 301– members of this committee serve as 60 days of the date of this publication.
796–9001, FAX: 301–847–8533, ACPS– Special Government Employees. The ADDRESSES: Send your written
CP@fda.hhs.gov. core of voting members may include one comments, requests for more
SUPPLEMENTARY INFORMATION: Pursuant technically qualified member, selected information on the collection, or
to 41 CFR 102–3.65 and approval by the by the Commissioner or designee, who requests to obtain a copy of the data
Department of Health and Human is identified with consumer interests collection instrument and instructions
Services pursuant to 45 CFR part 11 and and is recommended by either a to Tamara Clay by one of the following
by the General Services Administration, consortium of consumer-oriented methods:
FDA is announcing the renewal of the organizations or other interested • Mail: Tamara Clay, Information
Pharmaceutical Science and Clinical persons. In addition to the voting Collection Clearance Officer, Indian
Pharmacology Advisory Committee. The members, the Committee may include Health Service, Office of Management
committee is a discretionary Federal up to three non-voting members who are Services, Division of Regulatory Affairs,
advisory committee established to identified with industry interests. 5600 Fishers Lane, Mail Stop 09E70,
provide advice to the Commissioner. Further information regarding the Rockville, MD 20857.
The Pharmaceutical Science and most recent charter and other • Phone: 301–443–4750.
Clinical Pharmacology Advisory information can be found at: http:// • Email: tamara.clay@ihs.gov.
Committee advises the Commissioner or www.fda.gov/AdvisoryCommittees/ • Fax: 301–443–2316.
designee in discharging responsibilities CommitteesMeetingMaterials/Drugs/ SUPPLEMENTARY INFORMATION: This
as they relate to helping to ensure safe AdvisoryCommitteeforPharmaceutical previously approved information
and effective drugs for human use and, ScienceandClinicalPharmacology/ucm collection project was last published in
as required, any other product for which 107524.htm or by contacting the the Federal Register (78 FR 2412) on
the Food and Drug Administration has Designated Federal Officer (see FOR January 11, 2013, and allowed 30 days
regulatory responsibility. FURTHER INFORMATION CONTACT). Due to for public comment. No public
The Committee reviews and evaluates a change in the committee name, FDA comment was received in response to
scientific, clinical, and technical issues will publish a final rule will in the the notice. This notice announces our
related to the safety and effectiveness of Federal Register amending 21 CFR intent to submit the collection, which
drug products for use in the treatment 14.100. expires April 30, 2016, to OMB for
of a broad spectrum of human diseases; This document is issued under the approval of an extension, and to solicit
the quality characteristics which such Federal Advisory Committee Act (5 comments on specific aspects of the
drugs purport or are represented to U.S.C. app.). For general information information collection. A copy of the
have, and as required, any other product related to FDA advisory committees, supporting statement is available at
for which the Food and Drug please visit us at http://www.fda.gov/ www.regulations.gov (see Docket ID
Administration has regulatory AdvisoryCommittees/default.htm. IHS–2016–1).
responsibility; and makes appropriate Dated: January 15, 2016. Title of Collection: 0917–0030, IHS
recommendations to the Commissioner Jill Hartzler Warner, Forms to Implement the Privacy Rule
of Food and Drugs. The Committee may Associate Commissioner for Special (45 CFR parts 160 and 164). Type of
also review Agency sponsored Programs. Information Collection Request:
intramural and extramural biomedical [FR Doc. 2016–01181 Filed 1–21–16; 8:45 am] Extension of the currently approved
research programs in support of FDA’s BILLING CODE 4164–01–P information collection, 0917–0030, IHS
drug regulatory responsibilities and its Forms to Implement the Privacy Rule
critical path initiatives related to (45 CFR parts 160 and 164). Form(s):
improving the efficacy and safety of DEPARTMENT OF HEALTH AND IHS–810, IHS–912–1, IHS–912–2, IHS–
drugs and improving the efficiency of HUMAN SERVICES 913, and IHS–917. Need and Use of
drug development. Information Collection: This collection
The Committee shall consist of a core Indian Health Service of information is made necessary by the
of 14 voting members including two Department of Health and Human
Chairpersons. Members and Request for Public Comment: 60 Day Services Rule entitled ‘‘Standards for
Chairpersons are selected by the Information Collection: Indian Health Privacy of Individually Identifiable
Commissioner or designee from among Service Forms To Implement the Health Information’’ (Privacy Rule) (45
authorities knowledgeable in the fields Privacy Rule CFR parts 160 and 164). The Privacy
of pharmaceutical sciences AGENCY: Indian Health Service, HHS. Rule implements the privacy
(pharmaceutical manufacturing, ACTION:Notice and request for requirements of the Administrative
bioequivalence research, laboratory comments. Request for extension of Simplification subtitle of the Health
analytical techniques, pharmaceutical approval. Insurance Portability and
chemistry, physiochemistry, Accountability Act of 1996, creates
biochemistry, molecular biology, SUMMARY: In compliance with the national standards to protect
immunology, microbiology); clinical Paperwork Reduction Act of 1995, the individual’s personal health
pharmacology (dose-response, Indian Health Service (IHS) invites the information, and gives patients
general public to comment on the
mstockstill on DSK4VPTVN1PROD with NOTICES
pharmacokinetics-pharmacodynamics, increased access to their medical
modeling and simulation, information collection titled, ‘‘IHS records. 45 CFR 164.508, 164.522,
pharmacogenomics, clinical trial design, Forms to Implement the Privacy Rule 164.526 and 164.528 of the Rule require
pediatrics and special populations and (45 CFR parts 160 and 164),’’ Office of the collection of information to
innovative methods in drug Management and Budget (OMB) Control implement these protection standards
development); biostatistics, related Number 0917–0030. and access requirements. The IHS will
biomedical and pharmacological DATES: Comment Due Date: March 22, continue to use the following data
specialties, current good manufacturing 2016. Your comments regarding this collection instruments to meet the
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![Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Notices 3807
information collection requirements information, and whether IHS agreed or information. If the covered entity
contained in the Rule. disagreed with the restriction. Section accepts the requested amendment, in
45 CFR 164.508: This provision 164.522(a)(2) permits a covered entity to whole or in part, the covered entity
requires covered entities to obtain or terminate its agreement to a restriction must inform the individual that the
receive a valid authorization for its use if the individual agrees to or requests amendment is accepted. If the covered
or disclosure of protected health the termination in writing. The form entity denies the requested amendment,
information for other than for treatment, IHS–912–2 ‘‘Request for Revocation of in whole or in part, the covered entity
payment and healthcare operations. Restriction(s)’’ is used to document the must provide the individual with a
Under the provision individuals may agency or individual request to written denial. The form IHS–917
initiate a written authorization terminate a formerly agreed to ‘‘Request for Correction/Amendment of
permitting covered entities to release restriction regarding the use and Protected Health Information’’ will be
their protected health information to disclosure of protected health used to document an individual’s
entities of their choosing. The form information.
IHS–810 ‘‘Authorization for Use or 45 CFR 164.528 and 45 CFR 5b.9(c): request to amend their protected health
Disclosure of Protected Health This provision requires covered entities information and the agency’s decision to
Information’’ is used to document an to permit individuals to request that the accept or deny the request. Completed
individual’s authorization to use or covered entity provide an accounting of forms used in this collection of
disclose their protected health disclosures of protected health information are filed in the IHS medical,
information. information made by the covered entity. health and billing record, a Privacy Act
45 CFR 164.522: Section 164.522(a)(1) The form IHS–913 ‘‘Request for an System of Records Notice. Affected
requires a covered entity to permit Accounting of Disclosures’’ is used to Public: Individuals and households.
individuals to request that the covered document an individual’s request for an Type of Respondents: Individuals.
entity restrict the use and disclosure of accounting of disclosures of their Burden Hours: The table below provides
their protected health information. The protected health information and the for this information collection: Types of
covered entity may or may not agree to agency’s handling of the request. data collection instruments, estimated
the restriction. The form IHS–912–1 45 CFR 164.526: This provision number of respondents, number of
‘‘Request for Restrictions(s)’’ is used to requires covered entities to permit an responses per respondent, average
document an individual’s request for individual to request that the covered burden hour per response, and total
restriction of their protected health entity amend protected health annual burden hour(s).
Number of Average
Number of Total annual
Data collection instrument responses per burden hour
respondents burden hours
respondent per response *
Authorization for Use or Disclosure of Protected Health Information (OMB
Form No. 0917–0030, IHS–810) .................................................................. 210,954 1 10/60 35,159
Request for Restriction(s) (OMB Form No. 0917–0030, IHS–912–1) ............ 214 1 10/60 36
Request for Revocation of Restriction(s) (OMB Form No. 0917–0030, IHS–
912–2) .......................................................................................................... 3 1 10/60 .5
Request for Accounting of Disclosures (OMB Form No. 0917–0030, IHS–
913) .............................................................................................................. 39 1 10/60 6.5
Request for Correction/Amendment of Protected Health Information (OMB
Form No. 0917–0030, IHS–917) .................................................................. 54 1 10/60 9
Total Annual Burden ................................................................................. 211,264 ........................ ........................ 35,211
* For ease of understanding, burden hours are provided in actual minutes.
The total estimated burden for this (e) ways to enhance the quality, DEPARTMENT OF HEALTH AND
collection of information is 35,211 utility, and clarity of the information HUMAN SERVICES
hours. There are no capital costs, being collected; and
operating costs and/or maintenance National Institutes of Health
(f) ways to minimize the public
costs to respondents. burden through the use of automated,
Requests for Comments: Your written Center for Scientific Review; Notice of
electronic, mechanical, or other Closed Meetings
comments and/or suggestions are
technological collection techniques or
invited on one or more of the following Pursuant to section 10(d) of the
other forms of information technology.
points: Federal Advisory Committee Act, as
(a) Whether the information collection Dated: January 13, 2016. amended (5 U.S.C. App.), notice is
activity is necessary to carry out an Robert G. McSwain, hereby given of the following meetings.
agency function; Principal Deputy Director, Indian Health The meetings will be closed to the
(b) whether the agency processes the Service. public in accordance with the
information collected in a useful and [FR Doc. 2016–01208 Filed 1–21–16; 8:45 am] provisions set forth in sections
mstockstill on DSK4VPTVN1PROD with NOTICES
timely fashion; BILLING CODE 4165–16–P
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
(c) the accuracy of the public burden as amended. The grant applications and
estimate (the estimated amount of time the discussions could disclose
needed for individual respondents to confidential trade secrets or commercial
provide the requested information); property such as patentable material,
(d) whether the methodology and and personal information concerning
assumptions used to determine the individuals associated with the grant
estimates are logical; applications, the disclosure of which
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Document Created: 2016-01-22 01:16:53
Document Modified: 2016-01-22 01:16:53
| 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 and request for comments. Request for extension of approval. | |
| FR Citation | 81 FR 3806 |
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