81_FR_76804 81 FR 76591 - Issuance of Final Guidance Publication

81 FR 76591 - Issuance of Final Guidance Publication

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 213 (November 3, 2016)

Page Range76591-76591
FR Document2016-26507

NIOSH announces the availability of the following final publication: ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione'' [DHHS(NIOSH) Publication Number 2016-111].

Federal Register, Volume 81 Issue 213 (Thursday, November 3, 2016)
[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Page 76591]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2013-0021; Docket Number NIOSH-245, 245-A]


Issuance of Final Guidance Publication

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of issuance of final guidance publication.

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

SUMMARY: NIOSH announces the availability of the following final 
publication: ``Criteria for a Recommended Standard: Occupational 
Exposure to Diacetyl and 2,3-pentanedione'' [DHHS(NIOSH) Publication 
Number 2016-111].

DATES: The final criteria document was published October 31, 2016.

ADDRESSES: This document may be obtained at the following link: http://www.cdc.gov/niosh/docs/2016-111.

FOR FURTHER INFORMATION CONTACT: Lauralynn McKernan, NIOSH/Division of 
Surveillance, Hazard Evaluations and Field Studies, 1090 Tusculum 
Avenue, MS R-12, Cincinnati, OH 45226. 513-533-8542 (not a toll free 
number).

SUPPLEMENTARY INFORMATION: On July 25, 2011, NIOSH published a notice 
of public meeting and request for comments on the draft ``Criteria for 
a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-
pentanedione.'' in the Federal Register (76 FR 44338). On October 18, 
2011, NIOSH published an extension of comment period (76 FR 64353). On 
April 11, 2012, NIOSH published an expanded charge for peer reviewers 
(77 FR 21777) and then on December 26, 2013, NIOSH published another 
notice (78 FR 78363) for review of revised Chapters 6 and 8 of the 
Criteria document. All comments received were reviewed and accepted 
where appropriate. Comments for Docket 245 are available at: http://www.cdc.gov/niosh/docket/archive/docket245.html. Comments for Docket 
245-A can be found in the docket at: www.regulations.gov, Docket No. 
CDC-2013-0021.

    Dated: October 28, 2016.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2016-26507 Filed 11-2-16; 8:45 am]
 BILLING CODE 4163-19-P



                                                                                    Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices                                                                                                76591

                                                  of questions that patients would like to                                strategies to facilitate implementation                                       intervention. To assess the effectiveness
                                                  ask their provider. These behavior                                      and integration of PHC into HIV primary                                       of the PHC intervention, patients
                                                  change tips and questions are also                                      care clinics; (3) collect and document                                        randomized to the intervention arm will
                                                  populated on a Patient Handout that                                     data on the cost of PHC intervention                                          provide their responses to the patient
                                                  patients may share with their provider.                                 implementation; and (4) document the                                          tailoring questions embedded within the
                                                  As such, PHC supports patients and                                      standard of care at each participating                                        intervention and all enrolled patients
                                                  providers during their clinical                                         clinic. The awardee of this cooperative                                       will consent to have their de-identified
                                                  encounter and promotes                                                  agreement is RTI. RTI has subcontracted                                       clinical values be made available via
                                                  communication. Finally, the PHC                                         with four clinical sites to implement the                                     passive data collection via the electronic
                                                  intervention has been designed from the                                 trial. The sub-contractors are the Atlanta
                                                                                                                                                                                                        medical record. In addition to the main
                                                  onset for wide-scale dissemination. Its                                 VA Medical Center (Atlanta, Georgia),
                                                                                                                                                                                                        trial, three to five key staff at each clinic
                                                  flexible digital strategy provides access                               Hillsborough County Health Department
                                                  on multiple devices and platforms. This                                 (Tampa, Florida), Rutgers Infectious                                          site will be selected to participate in the
                                                  approach makes PHC an important                                         Disease Practice (Newark, New Jersey),                                        PHC feasibility assessment which
                                                  intervention strategy to improve public                                 and Crescent Care (New Orleans,                                               includes an online survey and
                                                  health in communities that have a high                                  Louisiana). The four clinical sites are                                       qualitative interviews.
                                                  incidence of HIV infection.                                             well suited for this work, given the high                                        Finally, clinic staff who participate in
                                                     This data collection has four primary                                rates of patients with elevated viral                                         the implementation of the PHC
                                                  aims: (1) Implement a randomized trial                                  loads.                                                                        intervention will provide data on the
                                                  to test the efficacy of the PHC                                            During the 24-month implementation                                         cost of implementing the PHC
                                                  intervention for improving clinical                                     period, 1,010 patients will be enrolled                                       intervention. It is estimated that the
                                                  health outcomes, specifically viral load                                into the trial (505 intervention arm and                                      total burden hours for all data collection
                                                  and retention in care; (2)conduct a                                     505 control arm) across the four clinics                                      activities is 315.
                                                  feasibility assessment to determine                                     to evaluate the effectiveness of the PHC

                                                                                                                         ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                 Number of                 Average burden               Total response
                                                                                                                                                                    Number of
                                                       Type of respondent                                            Form name                                                                 responses per                per response                    burden
                                                                                                                                                                   respondents                   respondent                   (in hours)                  (in hours)

                                                  Persons eligible for study .....             PHC intervention trial consent .............                                          505                              1                      5/60                   42
                                                                                               Staff online survey consent ..................                                         20                              1                      5/60                    2
                                                  Enrolled participants .............          PHC tailoring questions ........................                                      505                              3                      5/60                  126
                                                                                               Online clinic staff survey ......................                                      20                              3                     15/60                   15
                                                                                               Clinic staff qualitative interview ............                                        20                              3                     40/60                   40
                                                                                               Non-research labor cost questionnaire                                                  12                              3                     75/60                   45
                                                                                               PHC labor cost questionnaire ..............                                            12                              3                     75/60                   45

                                                       Total ...............................   ...............................................................   ..........................   ..........................   ..........................              315



                                                  Leroy A. Richardson,                                                    SUMMARY:   NIOSH announces the                                                comment period (76 FR 64353). On
                                                  Chief, Information Collection Review Office,                            availability of the following final                                           April 11, 2012, NIOSH published an
                                                  Office of Scientific Integrity, Office of the                           publication: ‘‘Criteria for a                                                 expanded charge for peer reviewers (77
                                                  Associate Director for Science, Office of the                           Recommended Standard: Occupational                                            FR 21777) and then on December 26,
                                                  Director, Centers for Disease Control and                               Exposure to Diacetyl and 2,3-
                                                  Prevention.
                                                                                                                                                                                                        2013, NIOSH published another notice
                                                                                                                          pentanedione’’ [DHHS(NIOSH)                                                   (78 FR 78363) for review of revised
                                                  [FR Doc. 2016–26501 Filed 11–2–16; 8:45 am]                             Publication Number 2016–111].                                                 Chapters 6 and 8 of the Criteria
                                                  BILLING CODE 4163–18–P
                                                                                                                          DATES: The final criteria document was                                        document. All comments received were
                                                                                                                          published October 31, 2016.                                                   reviewed and accepted where
                                                  DEPARTMENT OF HEALTH AND                                                ADDRESSES: This document may be                                               appropriate. Comments for Docket 245
                                                  HUMAN SERVICES                                                          obtained at the following link: http://                                       are available at: http://www.cdc.gov/
                                                                                                                          www.cdc.gov/niosh/docs/2016–111.                                              niosh/docket/archive/docket245.html.
                                                  Centers for Disease Control and                                         FOR FURTHER INFORMATION CONTACT:                                              Comments for Docket 245–A can be
                                                  Prevention                                                              Lauralynn McKernan, NIOSH/Division                                            found in the docket at:
                                                  [CDC–2013–0021; Docket Number NIOSH–                                    of Surveillance, Hazard Evaluations and                                       www.regulations.gov, Docket No. CDC–
                                                  245, 245–A]                                                             Field Studies, 1090 Tusculum Avenue,                                          2013–0021.
                                                                                                                          MS R–12, Cincinnati, OH 45226. 513–                                             Dated: October 28, 2016.
                                                  Issuance of Final Guidance Publication                                  533–8542 (not a toll free number).                                            John Howard,
                                                  AGENCY:  National Institute for                                         SUPPLEMENTARY INFORMATION: On July                                            Director, National Institute for Occupational
                                                                                                                          25, 2011, NIOSH published a notice of
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                                                  Occupational Safety and Health                                                                                                                        Safety and Health, Centers for Disease Control
                                                  (NIOSH) of the Centers for Disease                                      public meeting and request for                                                and Prevention.
                                                  Control and Prevention (CDC),                                           comments on the draft ‘‘Criteria for a                                        [FR Doc. 2016–26507 Filed 11–2–16; 8:45 am]
                                                  Department of Health and Human                                          Recommended Standard: Occupational
                                                                                                                                                                                                        BILLING CODE 4163–19–P
                                                  Services (HHS).                                                         Exposure to Diacetyl and 2,3-
                                                                                                                          pentanedione.’’ in the Federal Register
                                                  ACTION: Notice of issuance of final
                                                                                                                          (76 FR 44338). On October 18, 2011,
                                                  guidance publication.
                                                                                                                          NIOSH published an extension of


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Document Created: 2016-11-03 03:23:52
Document Modified: 2016-11-03 03:23:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of issuance of final guidance publication.
DatesThe final criteria document was published October 31, 2016.
ContactLauralynn McKernan, NIOSH/Division of Surveillance, Hazard Evaluations and Field Studies, 1090 Tusculum Avenue, MS R-12, Cincinnati, OH 45226. 513-533-8542 (not a toll free number).
FR Citation81 FR 76591 

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