81 FR 28083 - Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 89 (May 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 89 (May 9, 2016)
| Page Range | 28083-28084 | |
| FR Document | 2016-10798 |
[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)] [Notices] [Pages 28083-28084] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected]. 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
![Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices 28083
Addendum XII: Medicare-Approved surgery published in the 3-month additional information, contact Stuart
Ventricular Assist Device (Destination period. This information is available at Caplan, RN, MAS (410–786–8564).
Therapy) Facilities (January through www.cms.gov/ [FR Doc. 2016–10819 Filed 5–6–16; 8:45 am]
March 2016) MedicareApprovedFacilitie/LVRS/ BILLING CODE 4120–01–P
Addendum XII includes a listing of list.asp#TopOfPage. For questions or
Medicare-approved facilities that additional information, contact Marie
receive coverage for ventricular assist Casey, BSN, MPH (410–786–7861). DEPARTMENT OF HEALTH AND
devices (VADs) used as destination Addendum XIV: Medicare-Approved HUMAN SERVICES
therapy. All facilities were required to Bariatric Surgery Facilities (January Food and Drug Administration
meet our standards in order to receive through March 2016)
coverage for VADs implanted as [Docket No. FDA–2015–N–4602]
destination therapy. On October 1, 2003, Addendum XIV includes a listing of
we issued our decision memorandum Medicare-approved facilities that meet Streamlining Regulations for Good
on VADs for the clinical indication of minimum standards for facilities Manufacturing Practices for Hearing
destination therapy. We determined that modeled in part on professional society Aids; Public Workshop; Extension of
VADs used as destination therapy are statements on competency. All facilities Comment Period
reasonable and necessary only if must meet our standards in order to
receive coverage for bariatric surgery AGENCY: Food and Drug Administration,
performed in facilities that have been HHS.
determined to have the experience and procedures. On February 21, 2006, we
issued our decision memorandum on Notification; extension of
ACTION:
infrastructure to ensure optimal patient comment period.
outcomes. We established facility bariatric surgery procedures. We
standards and an application process. determined that bariatric surgical SUMMARY: The Food and Drug
All facilities were required to meet our procedures are reasonable and necessary Administration (FDA or we) is
standards in order to receive coverage for Medicare beneficiaries who have a extending the comment period for the
for VADs implanted as destination body-mass index (BMI) greater than or document entitled ‘‘Streamlining
therapy. equal to 35, have at least one co- Regulations for Good Manufacturing
For the purposes of this quarterly morbidity related to obesity and have Practices for Hearing Aids; Public
notice, there were no specific updates been previously unsuccessful with Workshop’’ that appeared in the Federal
that have occurred to the list of medical treatment for obesity. This Register of January 7, 2016. In the
Medicare-approved facilities that meet decision also stipulated that covered document, FDA requested comments on
our standards in the 3-month period. bariatric surgery procedures are the appropriate level of good
This information is available at http:// reasonable and necessary only when manufacturing practices (GMPs)
www.cms.gov/ performed at facilities that are: (1) regulation to ensure the safety and
MedicareApprovedFacilitie/VAD/ certified by the American College of effectiveness of air-conduction hearing
list.asp#TopOfPage. For questions or Surgeons (ACS) as a Level 1 Bariatric aid devices. The Agency is taking this
additional information, contact Marie Surgery Center (program standards and action in response to requests for an
Casey, BSN, MPH (410–786–7861). requirements in effect on February 15, extension to allow interested persons
2006); or (2) certified by the American additional time to submit comments.
Addendum XIII: Lung Volume Society for Bariatric Surgery (ASBS) as DATES: FDA is extending the comment
Reduction Surgery (LVRS) (January a Bariatric Surgery Center of Excellence period on the document published
through March 2016) (BSCOE) (program standards and January 7, 2016 (81 FR 784). Submit
Addendum XIII includes a listing of requirements in effect on February 15, either electronic or written comments
Medicare-approved facilities that are 2006). by June 30, 2016.
eligible to receive coverage for lung There were no additions, deletions, or ADDRESSES: You may submit comments
volume reduction surgery. Until May editorial changes to Medicare-approved as follows:
17, 2007, facilities that participated in facilities that meet CMS’s minimum
the National Emphysema Treatment facility standards for bariatric surgery Electronic Submissions
Trial were also eligible to receive that have been certified by ACS and/or Submit electronic comments in the
coverage. The following three types of ASMBS in the 3-month period. This following way:
facilities are eligible for reimbursement information is available at • Federal eRulemaking Portal: http://
for Lung Volume Reduction Surgery www.cms.gov/ www.regulations.gov. Follow the
(LVRS): MedicareApprovedFacilitie/BSF/ instructions for submitting comments.
• National Emphysema Treatment list.asp#TopOfPage. For questions or Comments submitted electronically,
Trial (NETT) approved (Beginning 05/ additional information, contact Sarah including attachments, to http://
07/2007, these will no longer Fulton, MPH (410–786–2749). www.regulations.gov will be posted to
automatically qualify and can qualify Addendum XV: FDG–PET for Dementia the docket unchanged. Because your
only with the other programs); and Neurodegenerative Diseases comment will be made public, you are
• Credentialed by the Joint Clinical Trials (January through March solely responsible for ensuring that your
Commission (formerly, the Joint 2016) comment does not include any
Commision on Accreditation of confidential information that you or a
Healthcare Organizations (JCAHO)) There were no FDG–PET for Dementia third party may not wish to be posted,
mstockstill on DSK3G9T082PROD with NOTICES
under their Disease Specific and Neurodegenerative Diseases such as medical information, your or
Certification Program for LVRS; and Clinical Trials published in the 3-month anyone else’s Social Security number, or
• Medicare approved for lung period. confidential business information, such
transplants. This information is available on our as a manufacturing process. Please note
Only the first two types are in the list. Web site at www.cms.gov/ that if you include your name, contact
There were no updates to the listing of MedicareApprovedFacilitie/PETDT/ information, or other information that
facilities for lung volume reduction list.asp#TopOfPage. For questions or identifies you in the body of your
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![28084 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices
comments, that information will be accordance with 21 CFR 10.20 and other Hearing Aids’’ for 30 days, until June
posted on http://www.regulations.gov. applicable disclosure law. For more 30, 2016. The Agency believes that a 30-
• If you want to submit a comment information about FDA’s posting of day extension allows adequate time for
with confidential information that you comments to public dockets, see 80 FR interested persons to submit comments
do not wish to be made available to the 56469, September 18, 2015, or access without significantly delaying
public, submit the comment as a the information at: http://www.fda.gov/ regulation on these important issues.
written/paper submission and in the regulatoryinformation/dockets/ Dated: May 3, 2016.
manner detailed (see ‘‘Written/Paper default.htm. Leslie Kux,
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Associate Commissioner for Policy.
Written/Paper Submissions read background documents or the
electronic and written/paper comments [FR Doc. 2016–10798 Filed 5–6–16; 8:45 am]
Submit written/paper submissions as received, go to http:// BILLING CODE 4164–01–P
follows: www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the DEPARTMENT OF HEALTH AND
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts HUMAN SERVICES
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Lane, rm. 1061, Rockville, MD 20852. Food and Drug Administration
Management, 5630 Fishers Lane, Rm.
• For written/paper comments [Docket No. FDA–2016–N–0001]
1061, Rockville, MD 20852.
submitted to the Division of Dockets
FOR FURTHER INFORMATION CONTACT:
Management, FDA will post your Advisory Committee; Anesthetic and
comment, as well as any attachments, Srinivas Nandkumar, Food and Drug
Analgesic Drug Products Advisory
except for information submitted, Administration, Center for Devices and
Committee, Renewal
marked and identified, as confidential, Radiological Health, Bldg. 66, Rm. 2436,
if submitted as detailed in 10903 New Hampshire Ave., Silver AGENCY: Food and Drug Administration,
‘‘Instructions.’’ Spring, MD 20993, 301–796–6480, FAX: HHS.
Instructions: All submissions received 301–847–8126, Srinivas.nandkumar@ ACTION:Notice; renewal of advisory
must include the Docket No. FDA– fda.hhs.gov. committee.
2015–N–4602 for ‘‘Streamlining SUPPLEMENTARY INFORMATION: In the
Regulations for Good Manufacturing SUMMARY: The Food and Drug
Federal Register of January 7, 2016 (81
Practices for Hearing Aids; Public Administration (FDA) is announcing the
FR 784), FDA published a document
Workshop; Request for Comments.’’ renewal of the Anesthetic and Analgesic
with a 30-day comment period to
Received comments will be placed in Drug Products Advisory Committee by
request comments on the appropriate
the docket and, except for those the Commissioner of Food and Drugs
level of GMPs regulation to ensure the
submitted as ‘‘Confidential (the Commissioner). The Commissioner
safety and effectiveness of air-
Submissions,’’ publicly viewable at has determined that it is in the public
conduction hearing aid devices; the
http://www.regulations.gov or at the interest to renew the Anesthetic and
current regulations for air-conduction
Division of Dockets Management Analgesic Drug Products Advisory
hearing aids that may hinder
between 9 a.m. and 4 p.m., Monday Committee for an additional 2 years
innovation, reduce competition, and
through Friday. beyond the charter expiration date. The
lead to increased cost and reduced use
• Confidential Submissions—To new charter will be in effect until May
of these devices by Americans with age-
submit a comment with confidential 1, 2018.
related hearing loss; and the potential
information that you do not wish to be DATES: Authority for the Anesthetic and
exemption of hearing aids from the
made publicly available, submit your Quality System Regulation (QSReg,) Analgesic Drug Products Advisory
comments only as a written/paper through use of alternative standards Committee will expire on May 1, 2016,
submission. You should submit two developed in collaboration with key unless the Commissioner formally
copies total. One copy will include the stakeholders and standards determines that renewal is in the public
information you claim to be confidential development organizations, and interest.
with a heading or cover note that states recognized by FDA and recordkeeping FOR FURTHER INFORMATION CONTACT:
‘‘THIS DOCUMENT CONTAINS to ensure product quality. Comments on Stephanie L. Begansky, Center for Drug
CONFIDENTIAL INFORMATION.’’ The the ‘‘Streamlining Regulations for Good Evaluation and Research, Food and
Agency will review this copy, including Manufacturing Practices for Hearing Drug Administration, 10903 New
the claimed confidential information, in Aids’’ will inform the Agency on an Hampshire Ave., Bldg. 31, Rm. 2417,
its consideration of comments. The alternative model for quality Silver Spring, MD 20993–0002, (301)
second copy, which will have the verification. 796–9001, AADPAC@fda.hhs.gov.
claimed confidential information The Agency has received requests for SUPPLEMENTARY INFORMATION: Issued in
redacted/blacked out, will be available a 30-day extension of the comment 41 CFR 102–3.65 and approval by the
for public viewing and posted on http:// period for the document. Each request Department of Health and Human
www.regulations.gov. Submit both conveyed concern that the current 30- Services issued in 45 CFR part 11 and
copies to the Division of Dockets day comment period does not allow by the General Services Administration,
Management. If you do not wish your sufficient time to develop a meaningful FDA is announcing the renewal of the
name and contact information to be or thoughtful response to the document Anesthetic and Analgesic Drug Products
mstockstill on DSK3G9T082PROD with NOTICES
made publicly available, you can on ‘‘Streamlining Regulations for Good Advisory Committee. The committee is
provide this information on the cover Manufacturing Practices for Hearing a discretionary Federal advisory
sheet and not in the body of your Aids.’’ committee established to provide advice
comments and you must identify this FDA has considered the requests and to the Commissioner. The Anesthetic
information as ‘‘confidential.’’ Any is extending the comment period for the and Analgesic Drug Products Advisory
information marked as ‘‘confidential’’ document on ‘‘Streamlining Regulations Committee advises the Commissioner or
will not be disclosed except in for Good Manufacturing Practices for designee in discharging responsibilities
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Document Created: 2018-02-07 14:50:20
Document Modified: 2018-02-07 14:50:20
| 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 | Notification; extension of comment period. | |
| 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. | |
| 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, [email protected] | |
| FR Citation | 81 FR 28083 |
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