81 FR 75828 - Medical Device User Fee Amendments; Public Meeting; Request for Comments; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 211 (November 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 211 (November 1, 2016)
| Page Range | 75828-75828 | |
| FR Document | 2016-26318 |
[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)] [Notices] [Page 75828] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26318] [[Page 75828]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2872] Medical Device User Fee Amendments; Public Meeting; Request for Comments; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is extending the comment period for the Medical Device User Fee Amendments (MDUFA) reauthorization draft recommendations that were announced in the Federal Register on October 7, 2016. In that Federal Register notice, FDA requested comments on the draft recommendations related to the reauthorization of the medical device user fee amendments. The Agency is taking this action to allow interested persons the statutorily required 30 days to submit comments. DATES: FDA is extending the comment period on the MDUFA reauthorization draft recommendations published October 7, 2016 (81 FR 69829). Submit either electronic or written comments by November 28, 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 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-2016-N-2872 for ``Medical Device User Fee Amendments; Public Meeting; Request for Comments; Extension of Comment Period.'' 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: Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993, 301-796- 5178, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of October 7, 2016, FDA published a request for comments with a 30-day comment period beginning October 14, 2016, to request comments on MDUFA reauthorization draft recommendations. Because the Agency was unable to post the draft recommendations until October 25, 2016, and the statute requires a period of 30 days be provided for the public to provide comments on the draft recommendations, FDA is extending the comment period for the MDUFA reauthorization draft recommendations until November 28, 2016. Dated: October 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26318 Filed 10-31-16; 8:45 am] BILLING CODE 4164-01-P
![75828 Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Notices
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Food and Drug Administration Written/Paper Submissions
received, go to http://
Submit written/paper submissions as www.regulations.gov and insert the
[Docket No. FDA–2016–N–2872]
follows: docket number, found in brackets in the
Medical Device User Fee Amendments; • Mail/Hand delivery/Courier (for heading of this document, into the
Public Meeting; Request for written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Comments; Extension of Comment Dockets Management (HFA–305), Food and/or go to the Division of Dockets
Period and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, rm.
Lane, rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments FOR FURTHER INFORMATION CONTACT:
HHS. submitted to the Division of Dockets Aaron Josephson, Center for Devices
ACTION: Notice of public meeting; Management, FDA will post your and Radiological Health, Food and Drug
extension of comment period. comment, as well as any attachments, Administration, 10903 New Hampshire
except for information submitted, Ave., Bldg. 66, rm. 5449, Silver Spring,
SUMMARY: The Food and Drug marked and identified, as confidential,
Administration (FDA) is extending the MD 20993, 301–796–5178,
if submitted as detailed in Aaron.Josephson@fda.hhs.gov.
comment period for the Medical Device ‘‘Instructions.’’
User Fee Amendments (MDUFA) Instructions: All submissions received SUPPLEMENTARY INFORMATION: In the
reauthorization draft recommendations must include the Docket No. FDA– Federal Register of October 7, 2016,
that were announced in the Federal 2016–N–2872 for ‘‘Medical Device User FDA published a request for comments
Register on October 7, 2016. In that Fee Amendments; Public Meeting; with a 30-day comment period
Federal Register notice, FDA requested Request for Comments; Extension of beginning October 14, 2016, to request
comments on the draft Comment Period.’’ Received comments comments on MDUFA reauthorization
recommendations related to the will be placed in the docket and, except draft recommendations.
reauthorization of the medical device for those submitted as ‘‘Confidential Because the Agency was unable to
user fee amendments. The Agency is Submissions,’’ publicly viewable at post the draft recommendations until
taking this action to allow interested http://www.regulations.gov or at the October 25, 2016, and the statute
persons the statutorily required 30 days Division of Dockets Management requires a period of 30 days be provided
to submit comments. between 9 a.m. and 4 p.m., Monday for the public to provide comments on
through Friday. the draft recommendations, FDA is
DATES: FDA is extending the comment
• Confidential Submissions—To extending the comment period for the
period on the MDUFA reauthorization
submit a comment with confidential MDUFA reauthorization draft
draft recommendations published
information that you do not wish to be recommendations until November 28,
October 7, 2016 (81 FR 69829). Submit
made publicly available, submit your 2016.
either electronic or written comments
by November 28, 2016. comments only as a written/paper Dated: October 27, 2016.
ADDRESSES: You may submit comments submission. You should submit two Leslie Kux,
as follows: copies total. One copy will include the Associate Commissioner for Policy.
information you claim to be confidential [FR Doc. 2016–26318 Filed 10–31–16; 8:45 am]
Electronic Submissions with a heading or cover note that states BILLING CODE 4164–01–P
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
following way: CONFIDENTIAL INFORMATION.’’ The
• Federal eRulemaking Portal: http:// Agency will review this copy, including DEPARTMENT OF HEALTH AND
www.regulations.gov. Follow the the claimed confidential information, in HUMAN SERVICES
instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the Health Resources and Services
including attachments, to http:// claimed confidential information Administration
www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http:// Agency Information Collection
comment will be made public, you are www.regulations.gov. Submit both Activities: Proposed Collection: Public
solely responsible for ensuring that your copies to the Division of Dockets Comment Request; Nurse Anesthetist
comment does not include any Management. If you do not wish your Traineeship Program Specific Data
confidential information that you or a name and contact information to be Forms
third party may not wish to be posted, made publicly available, you can AGENCY: Health Resources and Services
such as medical information, your or provide this information on the cover Administration (HRSA), Department of
anyone else’s Social Security number, or sheet and not in the body of your Health and Human Services.
confidential business information, such comments and you must identify this ACTION: Notice.
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’ SUMMARY: In compliance with the
information, or other information that will not be disclosed except in requirement for opportunity for public
asabaliauskas on DSK3SPTVN1PROD with NOTICES
identifies you in the body of your accordance with 21 CFR 10.20 and other comment on proposed data collection
comments, that information will be applicable disclosure law. For more projects (Section 3506(c)(2)(A) of the
posted on http://www.regulations.gov. information about FDA’s posting of Paperwork Reduction Act of 1995),
• If you want to submit a comment comments to public dockets, see 80 FR HRSA announces plans to submit an
with confidential information that you 56469, September 18, 2015, or access Information Collection Request (ICR),
do not wish to be made available to the the information at: http://www.fda.gov/ described below, to the Office of
public, submit the comment as a regulatoryinformation/dockets/ Management and Budget (OMB). Prior
written/paper submission and in the default.htm. to submitting the ICR to OMB, HRSA
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Document Created: 2016-11-01 02:35:37
Document Modified: 2016-11-01 02:35:37
| 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 | Notice of public meeting; extension of comment period. | |
| Dates | FDA is extending the comment period on the MDUFA reauthorization draft recommendations published October 7, 2016 (81 FR 69829). Submit either electronic or written comments by November 28, 2016. | |
| Contact | Aaron Josephson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993, 301-796- 5178, [email protected] | |
| FR Citation | 81 FR 75828 |
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