44137 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 
FDA will begin the meeting by 
soliciting feedback regarding how 
stakeholders, such as patients and health care providers, think about burden related to REMS. The meeting will then focus on strategies for anticipating and addressing REMS burden and access issues in several broad topic areas (including several areas identified in the key opinions and recommendations from stakeholders in the Standardizing and Evaluating REMS Report). Potential discussion topics are described in this document. For topics related to strategies for minimizing burden and barriers to patient access (topics 1–3), FDA will present ongoing 
and planned Agency initiatives, solicit feedback on these initiatives, and ask for feedback on other opportunities for anticipating and minimizing burden and patient access issues. 
Potential topics for discussion include 
the following: 
•Topic 1: Understanding the 
stakeholder perspective. 
Discussion will focus on gaining a 
better understanding of how stakeholders, such as patients, health care providers, dispensers, and others, think about burden and access issues related to REMS—for example, understanding the different dimensions of burden (e.g., administrative, 
logistical, workflow) and better understanding the different types of patient access issues that are implicated by REMS. 
•Topic 2: Improved communication 
about the existence of a REMS and about what is required of stakeholders under that REMS. 
Discussion will focus on strategies to 
improve communications about REMS, including communications about the existence of a particular REMS or the requirements under a particular REMS program, and how to improve the clarity of REMS materials. 
•Topic 3: Improved integration of 
activities required under a REMS. 
Discussion will focus on two closely 
related subtopics: (1) Strategies to improve the integration of REMS requirements into the health care delivery system through process improvement (e.g., streamlining REMS 
processes that have an impact on stakeholder workflow or the care process, and reducing redundancies by leveraging existing training or certification requirements to meet REMS requirements); and (2) strategies to integrate REMS into electronic health care systems (e.g., electronic health 
records, decision support systems, and pharmacy management systems). 
•Topic 4: Improved methods for 
measuring the burden of REMS on the health care delivery system and the 
impact on patient access. 
Discussion will focus on identifying 
the most effective methods for evaluating the burden of REMS on the health care delivery system and the impact on patient access, with a goal of not only characterizing and quantifying these effects, but also identifying opportunities for improvements to a REMS program and better understanding the effect of changes to a program. This may include discussion of how to address methodological challenges in the measurement of burden and access, and how to incorporate stakeholder input into REMS design and assessment. 
FDA intends to make background 
material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the public meeting, and the background material will be posted on FDA’s Web site after the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm, and to the docket at 
http://www.regulations.gov. 
Dated: July 20, 2015. 
Leslie Kux, 
Associate Commissioner for Policy. 
[FR Doc. 2015–18149 Filed 7–23–15; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
[Docket No. FDA–2011–N–0146] 
Third-Party Auditor/Certification Body 
Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Notice. 
SUMMARY : The Food and Drug 
Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled ‘‘Third- Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.’’ The draft guidance, when finalized, will contain 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 the FDA Food Safety Modernization Act (FSMA). DATES : Although you can comment on 
any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments by October 7, 2015. 
ADDRESSES : Submit written requests for 
single copies of the draft guidance to Charlotte A. Christin, Office of Compliance, Center for Food Safety and Applied Nutrition (HFS–605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the 
SUPPLEMENTARY  
INFORMATION section for electronic 
access to the draft guidance. 
Submit electronic comments on the 
draft guidance to http://www.regulations.gov. Submit written 
comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
FOR FURTHER INFORMATION CONTACT : 
Charlotte A. Christin, Center for Food Safety and Applied Nutrition (HFS– 605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–3708. 
SUPPLEMENTARY INFORMATION : 
I. Background 
We are announcing the availability of 
a draft guidance for industry and FDA staff entitled ‘‘Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards’’ (draft guidance). This draft guidance is being made available consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on ‘‘Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of the applicable statutes and regulations. 
Section 808 of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 384d) was added by FSMA and directs FDA to establish a program for the recognition of accreditation bodies that accredit third-party auditors/certification bodies to conduct food safety audits and to issue food and/or facility certifications that FDA may use in certain circumstances to facilitate the entry of foods presented for import. 
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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 finalized, it will serve as a companion 
guidance document to the final rule. 
II. Paperwork Reduction Act of 1995 
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 http://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 http://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 http://www.regulations.gov. 
IV. Electronic Access 
Persons with access to the Internet 
may obtain the draft guidance at either 
http://www.fda.gov/FoodGuidances or 
http://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] 
BILLING CODE 4164–01–P 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: http://www.hrsa.gov/advisorycommittees/mchbadvisory/InfantMortality/index.html. 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] 
BILLING CODE 4165–15–P 
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