Advisory Committee on Infant Mortality: Change in Meeting Dates, 44138 [2015-18179]
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44138
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
Section 808(b)(2) of the FD&C Act
requires FDA to develop model
accreditation standards that recognized
accreditation bodies shall use to qualify
third-party auditors/certification bodies
for accreditation, and in so doing, to
look to existing standards for
certification bodies (as of the date of
enactment of FSMA) to avoid
unnecessary duplication of efforts and
costs. This draft guidance, when
finalized, will constitute the model
accreditation standards referred to in
section 808(b)(2) of the FD&C Act. The
draft guidance contains FDA
recommendations on third-party
auditor/certification body qualifications
for accreditation to conduct food safety
audits and to issue food and/or facility
certifications under an FDA program
required by FSMA.
FDA was guided in developing this
draft guidance, in part, by the National
Technology Transfer and Advancement
Act of 1995, which directs Federal
Agencies to use voluntary consensus
standards in lieu of government-unique
standards, except where inconsistent
with law or otherwise impractical.
In developing the draft guidance, FDA
considered several voluntary consensus
standards for their relevance to the
qualifications of third-party auditors/
certification bodies that would certify
foreign food facilities and/or their foods
for conformance with the requirements
of the FD&C Act. FDA also sought to
identify the standards most commonly
used by stakeholders (e.g., other
governments, public and private
accreditation bodies, the food industry,
and the international standards
community) in qualifying third-party
auditors/certification bodies for
conducting food safety audits. As a
result, FDA was guided in developing
the draft model accreditation standards
guidance document by International
Organization for Standardization (ISO)/
International Electrotechnical
Commission (IEC) ISO/IEC 17021:
Conformity Assessment—Requirements
for bodies providing audit and
certification management systems
(2011) (‘‘ISO/IEC 17021:2011’’) and
included an appendix containing a
crosswalk between ISO/IEC 17021:2011
and ISO/IEC 17065: Conformity
assessment—Requirements for bodies
certifying products, processes and
services (‘‘ISO/IEC 17065:2012’’).
The draft guidance document is
issued as a companion to the proposed
rule ‘‘Accreditation of Third-Party
Auditors/Certification Bodies to
Conduct Food Safety Audits and to
Issue Certifications’’ that was published
in the Federal Register of July 29, 2013
(78 FR 45781). When this guidance is
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finalized, it will serve as a companion
guidance document to the final rule.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Paperwork Reduction Act of 1995
Health Resources and Services
Administration
This draft guidance refers to proposed
collections of information described in
FDA’s July 29, 2013, proposed rule on
Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food
Safety Audits and to Issue
Certifications, which this draft guidance
is intended to interpret. The proposed
collections of information in the
proposed rule are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520). As required by the PRA, FDA has
published an analysis of the information
collection provisions of the proposed
rule (see 78 FR 45781 at 45825,
reference 25, pages 216–239, available at
https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm) and has
submitted the proposed collections to
OMB for approval.
III. Comments
Interested persons may submit either
electronic comments regarding the draft
guidance to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18142 Filed 7–23–15; 8:45 am]
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PO 00000
Advisory Committee on Infant
Mortality: Change in Meeting Dates
ACTION:
Notice of change in meeting
dates.
Health Resources and
Services Administration is issuing this
notice to change the meeting dates for
the Notice is hereby given of a change
in the meeting of the Secretary’s
Advisory Committee on Infant Mortality
(SACIM). The meeting was originally
scheduled for July 13–14, 2015 and was
published in the Federal Register on
June 26, 2015, 80 FR 123 (page 36826).
SUMMARY:
The meeting dates have changed
to August 10, 2015, starting at 8:30 a.m.
(EST) and ending at 5 p.m. (EST) and
August 11, 2015, starting at 8:30 a.m.
(EST) and ending at 3:30 p.m. (EST).
The meeting remains virtual via
webinar and phone using the following
links: URL: https://
hrsa.connectsolutions.com/sacim_
seminar_200/. Call-In Number:
1.888.942.8170. Passcode: 3494113.
For more details, please visit the
ACIM Web site: https://www.hrsa.gov/
advisorycommittees/mchbadvisory/
InfantMortality/. The meeting
is open to the public with attendance
limited to availability of call-in lines.
DATES:
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the Committee should contact Michael
C. Lu, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and
Services Administration, Room 18 W,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone:
(301) 443–2170.
Individuals who are submitting public
comments or who have questions
regarding the meeting and location
should contact David S. de la Cruz,
Ph.D., M.P.H., SACIM Designated
Federal Official, HRSA, Maternal and
Child Health Bureau, telephone: (301)
443–0543, email: David.delaCruz@
hrsa.hhs.gov. Public comments must be
submitted to Dr. de la Cruz by email no
later than August 3, 2015.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015–18179 Filed 7–23–15; 8:45 am]
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Agencies
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Page 44138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18179]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Committee on Infant Mortality: Change in Meeting Dates
ACTION: Notice of change in meeting dates.
-----------------------------------------------------------------------
SUMMARY: Health Resources and Services Administration is issuing this
notice to change the meeting dates for the Notice is hereby given of a
change in the meeting of the Secretary's Advisory Committee on Infant
Mortality (SACIM). The meeting was originally scheduled for July 13-14,
2015 and was published in the Federal Register on June 26, 2015, 80 FR
123 (page 36826).
DATES: The meeting dates have changed to August 10, 2015, starting at
8:30 a.m. (EST) and ending at 5 p.m. (EST) and August 11, 2015,
starting at 8:30 a.m. (EST) and ending at 3:30 p.m. (EST).
The meeting remains virtual via webinar and phone using the
following links: URL: https://hrsa.connectsolutions.com/sacim_seminar_200/. Call-In Number: 1.888.942.8170. Passcode: 3494113.
For more details, please visit the ACIM Web site: https://www.hrsa.gov/advisorycommittees/mchbadvisory/InfantMortality/. The meeting is open to the public with attendance limited
to availability of call-in lines.
FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding
the Committee should contact Michael C. Lu, M.D., M.P.H., Executive
Secretary, ACIM, Health Resources and Services Administration, Room 18
W, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857,
Telephone: (301) 443-2170.
Individuals who are submitting public comments or who have
questions regarding the meeting and location should contact David S. de
la Cruz, Ph.D., M.P.H., SACIM Designated Federal Official, HRSA,
Maternal and Child Health Bureau, telephone: (301) 443-0543, email:
David.delaCruz@hrsa.hhs.gov. Public comments must be submitted to Dr.
de la Cruz by email no later than August 3, 2015.
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-18179 Filed 7-23-15; 8:45 am]
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