Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Extension of Comment Period, 28083-28084 [2016-10798]

Download as PDF Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January through March 2016) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, there were no specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This information is available at https:// www.cms.gov/ MedicareApprovedFacilitie/VAD/ list.asp#TopOfPage. For questions or additional information, contact Marie Casey, BSN, MPH (410–786–7861). mstockstill on DSK3G9T082PROD with NOTICES Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through March 2016) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/ 07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction VerDate Sep<11>2014 17:44 May 06, 2016 Jkt 238001 surgery published in the 3-month period. This information is available at www.cms.gov/ MedicareApprovedFacilitie/LVRS/ list.asp#TopOfPage. For questions or additional information, contact Marie Casey, BSN, MPH (410–786–7861). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (January through March 2016) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one comorbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS’s minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www.cms.gov/ MedicareApprovedFacilitie/BSF/ list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MPH (410–786–2749). Addendum XV: FDG–PET for Dementia and Neurodegenerative Diseases Clinical Trials (January through March 2016) There were no FDG–PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our Web site at www.cms.gov/ MedicareApprovedFacilitie/PETDT/ list.asp#TopOfPage. For questions or PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 28083 additional information, contact Stuart Caplan, RN, MAS (410–786–8564). [FR Doc. 2016–10819 Filed 5–6–16; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–4602] Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notification; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled ‘‘Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop’’ that appeared in the Federal Register of January 7, 2016. In the document, FDA requested comments on the appropriate level of good manufacturing practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the document published January 7, 2016 (81 FR 784). Submit either electronic or written comments by June 30, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your E:\FR\FM\09MYN1.SGM 09MYN1 28084 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–N–4602 for ‘‘Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Request for Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in VerDate Sep<11>2014 17:44 May 06, 2016 Jkt 238001 accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Srinivas Nandkumar, Food and Drug Administration, Center for Devices and Radiological Health, Bldg. 66, Rm. 2436, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–6480, FAX: 301–847–8126, Srinivas.nandkumar@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of January 7, 2016 (81 FR 784), FDA published a document with a 30-day comment period to request comments on the appropriate level of GMPs regulation to ensure the safety and effectiveness of airconduction hearing aid devices; the current regulations for air-conduction hearing aids that may hinder innovation, reduce competition, and lead to increased cost and reduced use of these devices by Americans with agerelated hearing loss; and the potential exemption of hearing aids from the Quality System Regulation (QSReg,) through use of alternative standards developed in collaboration with key stakeholders and standards development organizations, and recognized by FDA and recordkeeping to ensure product quality. Comments on the ‘‘Streamlining Regulations for Good Manufacturing Practices for Hearing Aids’’ will inform the Agency on an alternative model for quality verification. The Agency has received requests for a 30-day extension of the comment period for the document. Each request conveyed concern that the current 30day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the document on ‘‘Streamlining Regulations for Good Manufacturing Practices for Hearing Aids.’’ FDA has considered the requests and is extending the comment period for the document on ‘‘Streamlining Regulations for Good Manufacturing Practices for PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Hearing Aids’’ for 30 days, until June 30, 2016. The Agency believes that a 30day extension allows adequate time for interested persons to submit comments without significantly delaying regulation on these important issues. Dated: May 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–10798 Filed 5–6–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Anesthetic and Analgesic Drug Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2018. DATES: Authority for the Anesthetic and Analgesic Drug Products Advisory Committee will expire on May 1, 2016, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, (301) 796–9001, AADPAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Issued in 41 CFR 102–3.65 and approval by the Department of Health and Human Services issued in 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Anesthetic and Analgesic Drug Products Advisory Committee advises the Commissioner or designee in discharging responsibilities SUMMARY: E:\FR\FM\09MYN1.SGM 09MYN1

Agencies

[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28083-28084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10798]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4602]


Streamlining Regulations for Good Manufacturing Practices for 
Hearing Aids; Public Workshop; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the document entitled ``Streamlining Regulations for 
Good Manufacturing Practices for Hearing Aids; Public Workshop'' that 
appeared in the Federal Register of January 7, 2016. In the document, 
FDA requested comments on the appropriate level of good manufacturing 
practices (GMPs) regulation to ensure the safety and effectiveness of 
air-conduction hearing aid devices. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the document published 
January 7, 2016 (81 FR 784). Submit either electronic or written 
comments by June 30, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your

[[Page 28084]]

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-4602 for ``Streamlining Regulations for Good Manufacturing 
Practices for Hearing Aids; Public Workshop; Request for Comments.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Srinivas Nandkumar, Food and Drug 
Administration, Center for Devices and Radiological Health, Bldg. 66, 
Rm. 2436, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-
6480, FAX: 301-847-8126, Srinivas.nandkumar@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 7, 2016 
(81 FR 784), FDA published a document with a 30-day comment period to 
request comments on the appropriate level of GMPs regulation to ensure 
the safety and effectiveness of air-conduction hearing aid devices; the 
current regulations for air-conduction hearing aids that may hinder 
innovation, reduce competition, and lead to increased cost and reduced 
use of these devices by Americans with age-related hearing loss; and 
the potential exemption of hearing aids from the Quality System 
Regulation (QSReg,) through use of alternative standards developed in 
collaboration with key stakeholders and standards development 
organizations, and recognized by FDA and recordkeeping to ensure 
product quality. Comments on the ``Streamlining Regulations for Good 
Manufacturing Practices for Hearing Aids'' will inform the Agency on an 
alternative model for quality verification.
    The Agency has received requests for a 30-day extension of the 
comment period for the document. Each request conveyed concern that the 
current 30-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the document on ``Streamlining 
Regulations for Good Manufacturing Practices for Hearing Aids.''
    FDA has considered the requests and is extending the comment period 
for the document on ``Streamlining Regulations for Good Manufacturing 
Practices for Hearing Aids'' for 30 days, until June 30, 2016. The 
Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
regulation on these important issues.

    Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10798 Filed 5-6-16; 8:45 am]
 BILLING CODE 4164-01-P
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