81 FR 10633 - Designation of a Class of Employees for Addition to the Special Exposure Cohort
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 40 (March 1, 2016)
Federal Register Volume 81, Issue 40 (March 1, 2016)
| Page Range | 10633-10634 | |
| FR Document | 2016-04415 |
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)] [Notices] [Pages 10633-10634] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04415] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Designation of a Class of Employees for Addition to the Special Exposure Cohort AGENCY: National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: HHS gives notice of a decision to designate a class of employees from the Battelle Laboratories--King Avenue site in [[Page 10634]] Columbus, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. FOR FURTHER INFORMATION CONTACT: Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 1-877-222-7570. Information requests can also be submitted by email to [email protected]. SUPPLEMENTARY INFORMATION: On February 18, 2016, as provided for under 42 U.S.C. 7384l(14)(C),the Secretary of HHS designated the following class of employees as an addition to the SEC: All Atomic Weapons Employees who worked at the facility owned by the Battelle Laboratories at the King Avenue site in Columbus, Ohio, during the period from July 1, 1956, through December 31, 1970, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort. This designation will become effective on March 19, 2016, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC. Authority: 42 U.S.C. 7384q(b). 42 U.S.C. 7384l(14)(C). John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2016-04415 Filed 2-29-16; 8:45 am] BILLING CODE 4163-19-P
![Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices 10633
received, go to http:// FDA has developed this policy to supersede the document of the same
www.regulations.gov and insert the assure that patients with C. difficile title, dated July 2013.
docket number, found in brackets in the infection not responding to standard The draft guidance is being issued
heading of this document, into the therapies may have access to this consistent with FDA’s good guidance
‘‘Search’’ box and follow the prompts, treatment, while addressing and practices regulation (21 CFR 10.115).
and/or go to the Division of Dockets controlling the risks that centralized The draft guidance, when finalized, will
Management, 5630 Fishers Lane, Rm. manufacturing in stool banks presents to represent the current thinking of FDA
1061, Rockville, MD 20852. subjects. FDA intends for this to be an on ‘‘Enforcement Policy Regarding
Submit written requests for single interim policy, while the Agency Investigational New Drug Requirements
copies of the draft guidance to the Office develops a comprehensive approach for for Use of Fecal Microbiota for
of Communication, Outreach and the study and use of FMT products Transplantation to Treat Clostridium
Development, Center for Biologics under IND. difficile Infection Not Responsive to
Evaluation and Research (CBER), Food A stool bank is defined, for the Standard Therapies.’’ It does not
and Drug Administration, 10903 New purpose of this guidance, as an establish any rights for any person and
Hampshire Ave., Bldg. 71, Rm. 3128, establishment that collects, prepares, is not binding on FDA or the public.
Silver Spring, MD 20993–0002. Send and stores FMT product for distribution You can use an alternative approach if
one self-addressed adhesive label to to other establishments, health care it satisfies the requirements of the
assist the office in processing your providers, or other entities for use in applicable statutes and regulations.
requests. The draft guidance may also be patient therapy or clinical research. An
establishment that collects or prepares II. Paperwork Reduction Act of 1995
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See FMT products solely under the The draft guidance refers to
the SUPPLEMENTARY INFORMATION section direction of licensed health care previously approved collections of
for electronic access to the draft providers for the purpose of treating information found in FDA regulations.
guidance document. their patients (e.g., a hospital laboratory) These collections of information are
is not considered to be a stool bank subject to review by the Office of
FOR FURTHER INFORMATION CONTACT:
under this guidance. Management and Budget (OMB) under
Gretchen Opper, Center for Biologics
In the draft guidance, FDA provides the Paperwork Reduction Act of 1995
Evaluation and Research, Food and that the stool bank sponsor may request
Drug Administration, 10903 New (44 U.S.C. 3501–3520). The collections
a waiver of certain IND regulations of information in 21 CFR part 312 have
Hampshire Ave., Bldg. 71, Rm. 7301, relating to the obligations of
Silver Spring, MD 20993–0002, 240– been approved under OMB control
investigators and subinvestigators (e.g., number 0910–0014. The collections of
402–7911. certain sections of the Statement of information in 21 CFR part 50 have been
SUPPLEMENTARY INFORMATION: Investigator Form FDA 1572 that may approved under OMB control number
I. Background not be applicable to FMT provided to 0910–0755.
the health care provider to treat their
FDA is announcing the availability of patients) (21 CFR 312.10). FDA is III. Electronic Access
a draft document entitled ‘‘Enforcement requesting comments on which IND Persons with access to the Internet
Policy Regarding Investigational New regulations are appropriate to waive. In may obtain the draft guidance at either
Drug Requirements for Use of Fecal particular, FDA is requesting comments http://www.fda.gov/
Microbiota for Transplantation to Treat on the requirement for institutional BiologicsBloodVaccines/
Clostridium difficile Infection Not review board review of the use of FMT GuidanceCompliance
Responsive to Standard Therapies.’’ The to treat patients with C. difficile RegulatoryInformation/Guidances/
draft guidance document provides infection not responding to standard default.htm or http://
members of the medical and scientific therapies when the FMT is provided by www.regulations.gov.
community and other interested persons a stool bank (21 CFR 312.23(a)(1)(iv)
with notice that, when finalized, we Dated: February 23, 2016.
and 21 CFR 312.66).
intend to exercise enforcement In the draft guidance, FDA proposes Leslie Kux,
discretion under limited conditions, a revised policy with regard to patient Associate Commissioner for Policy.
regarding the IND requirements for the access to FMT. The provision that the [FR Doc. 2016–04372 Filed 2–29–16; 8:45 am]
use of FMT to treat C. difficile infection donor be known either to the patient or BILLING CODE 4164–01–P
not responding to standard therapies. to the treating licensed health care
FDA intends to exercise this discretion, provider, a concept that was used in the
provided that: (1) The licensed health March 2014 draft guidance, was subject DEPARTMENT OF HEALTH AND
care provider treating the patient to difficulties in interpretation, and the HUMAN SERVICES
obtains adequate consent from the revised approach more accurately
patient or his or her legally authorized reflects our intent to mitigate risk, based Designation of a Class of Employees
representative for the use of FMT on the number of patients exposed to a for Addition to the Special Exposure
products. The consent should include, particular donor or manufacturing Cohort
at a minimum, a statement that the use practice rather than the risk inherent AGENCY: National Institute for
of FMT products to treat C. difficile is from any one donor. Although FDA Occupational Safety and Health
investigational and a discussion of its acknowledges that directed donations
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(NIOSH), Centers for Disease Control
reasonably foreseeable risks; (2) the present different risks than stool bank and Prevention, Department of Health
FMT product is not obtained from a donations, the number of persons and Human Services (HHS).
stool bank; and (3) the stool donor and exposed through a directed donation ACTION: Notice.
stool are qualified by screening and will be limited. FDA also requests
testing performed under the direction of comments on this revised policy. The SUMMARY: HHS gives notice of a
the licensed health care provider for the draft guidance replaces the draft decision to designate a class of
purpose of providing the FMT product guidance of the same title, dated March employees from the Battelle
for treatment of the patient. 2014 and, when finalized, is intended to Laboratories—King Avenue site in
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![10634 Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
Columbus, Ohio, as an addition to the Personal Health Record Model Privacy The MPN has two sections: (1) The
Special Exposure Cohort (SEC) under Notice (MPN) developed by ONC and ‘‘Release’’ section; and (2) the ‘‘Secure’’
the Energy Employees Occupational published in 2011. In response to section. Both sections of the MPN
Illness Compensation Program Act of stakeholder requests for an electronic include model language that informs
2000. means to inform consumers about how consumers about how a PHR company
FOR FURTHER INFORMATION CONTACT: health technology products store, use, is using an individual’s health
Stuart L. Hinnefeld, Director, Division and share health information (especially information. The current MPN can be
of Compensation Analysis and Support, products of health technology found here, but we note that it is no
NIOSH, 1090 Tusculum Avenue, MS C– developers not covered by the Health longer available for use. Additional
46, Cincinnati, OH 45226–1938, Insurance Portability and background on the MPN can be found
Telephone 1–877–222–7570. Accountability Act of 1996, Pub. L. 104– at: https://www.healthit.gov/policy-
Information requests can also be 191), we have initiated a process to researchers-implementers/personal-
submitted by email to DCAS@CDC.GOV. update the MPN to better align with the health-record-phr-model-privacy-notice.
current consumer health technology Since the development of the MPN,
SUPPLEMENTARY INFORMATION: On
landscape. the consumer health technology
February 18, 2016, as provided for landscape has greatly evolved. More
under 42 U.S.C. 7384l(14)(C),the DATES: To be assured consideration, consumers are now able to
Secretary of HHS designated the electronic comments must be received electronically access their health
following class of employees as an at one of the addresses provided below, information than ever before. Not only
addition to the SEC: no later than 5 p.m. on April 15, 2016. are consumers interacting with their
All Atomic Weapons Employees who ADDRESSES: You may submit comments, clinical and claims data (often collected
worked at the facility owned by the Battelle identified by MPN RFI, by either of the and maintained by health care providers
Laboratories at the King Avenue site in following two methods (please do not and health plans regulated under the
Columbus, Ohio, during the period from July submit duplicate comments). Health Insurance Portability and
1, 1956, through December 31, 1970, for a
number of work days aggregating at least 250 • ONC Web site: Follow the Accountability Act of 1996 (HIPAA)
work days, occurring either solely under this instructions for submitting comments. (i.e., ‘‘covered entities’’)), but they are
employment, or in combination with work Attachments should be in Microsoft also interacting with fitness and
days within the parameters established for Word, Microsoft Excel, or Adobe PDF; wellness data from devices offered by
one or more other classes of employees however, we prefer Microsoft Word. health technology developers that may
included in the Special Exposure Cohort. https://www.healthit.gov/policy- not be regulated by HIPAA. In general,
This designation will become researchers-implementers/personal- HIPAA regulations govern how covered
effective on March 19, 2016, unless health-record-phr-model-privacy-notice. entities and their business associates
Congress provides otherwise prior to the • Email: ONCMPN@hhs.gov. maintain, access, use and disclose
effective date. After this effective date, FOR FURTHER INFORMATION CONTACT:
individually identifiable health
HHS will publish a notice in the Maya Uppaluru or Michael Lipinski, information and protected health
Federal Register reporting the addition 202–690–7151. information, otherwise known as
of this class to the SEC or the result of ‘‘PHI’’.1 Specifically, the HIPAA
SUPPLEMENTARY INFORMATION: In June regulations include requirements for:
any provision by Congress regarding the 2008, the Office of the National
decision by HHS to add the class to the keeping information private in the
Coordinator for Health Information Privacy Rule,2 which also includes
SEC. Technology (ONC) began a multi-phase notifying individuals about how their
Authority: 42 U.S.C. 7384q(b). 42 U.S.C. and iterative project to develop an easy-
7384l(14)(C). PHI can be accessed, used, and
to-understand, voluntary Personal disclosed; 3 adopting administrative,
John Howard, Health Record (PHR) Model Privacy technical and physical safeguards to
Director, National Institute for Occupational Notice (MPN) that any PHR company secure electronic PHI; 4 and mandating
Safety and Health. could adopt to communicate its notice to affected individuals when a
[FR Doc. 2016–04415 Filed 2–29–16; 8:45 am] information practices to its users. breach of PHI occurs.5 Health
BILLING CODE 4163–19–P
Developed in collaboration with the technology developers that may not be
Federal Trade Commission (FTC), the covered by HIPAA are often called
project’s goals were two-fold: (1) ‘‘non-covered entities’’ or ‘‘NCEs.’’
DEPARTMENT OF HEALTH AND Increase consumers’ awareness of PHR Health technology developers make
HUMAN SERVICES companies’ information practices; and available a diverse array of products,
(2) empower consumers by providing including mobile apps, wearable
Office of the Secretary them with an easy way to compare the devices, and sensors, and often display
information practices of two or more notices of their privacy and information
Request for Information on Updates to PHR companies. The MPN was designed practices to consumers. These
the ONC Voluntary Personal Health to enable PHR companies to easily enter developers may be subject to other
Record Model Privacy Notice their information practices and produce federal laws, including the FTC Act’s
AGENCY: Office of the National a notice to allow consumers to quickly prohibition on unfair or deceptive acts
Coordinator for Health Information learn and understand privacy and or practices,6 and the FTC’s Health
security policies and information
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Technology, Department of Health and
Human Services. practices, compare PHR company 1 45 CFR 160.103.
ACTION: Notice with comment; request
practices, and make informed decisions. 2 45 CFR 164.501 et seq.
for information. Similar to the Food and Drug 3 45 CFR 164.520; see also Office of Civil Rights
Administration’s Nutrition Facts Label, Model Notices of Privacy Practices: http://
www.hhs.gov/hipaa/for-professionals/privacy/
SUMMARY: The Office of the National this approach did not mandate specific guidance/model-notices-privacy-practices/.
Coordinator for Health Information policies, but rather was meant to 4 45 CFR 164.301 et seq.
Technology (ONC) seeks comments on encourage user-friendly transparency of 5 45 CFR 164.400–414.
the scope and content of the voluntary a company’s existing practices. 6 15 U.S.C. 45(a) (Section 5 of the FTC Act).
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Document Created: 2018-02-02 15:00:06
Document Modified: 2018-02-02 15:00:06
| 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. | |
| Contact | Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226-1938, Telephone 1-877-222-7570. Information requests can also be submitted by email to [email protected] | |
| FR Citation | 81 FR 10633 |
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