82 FR 42098 - B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 171 (September 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 171 (September 6, 2017)
| Page Range | 42098-42098 | |
| FR Document | 2017-18813 |
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)] [Notices] [Page 42098] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18813] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4642] B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting a document entitled ``B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application'' that appeared in the Federal Register of August 3, 2017 (82 FR 36150). The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food and Drug Administration, Bldg. 32, Rm. 3330, Silver Spring, MD 20993- 0002, 301-796-9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, August 3, 2017, in FR Doc. 2017-16377, on page 36150, the following correction is made: 1. On page 36150, in the second column, in the header of the document, ``Docket No. FDA-2017-N-0002'' is corrected to read ``Docket No. FDA-2017-N-4642''. Dated: August 28, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18813 Filed 9-5-17; 8:45 am] BILLING CODE 4164-01-P
![42098 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Crew Members .................................. Interview protocol ............................. 250 1 10/60 42
Total ........................................... ........................................................... ........................ ........................ ........................ 44
Leroy A. Richardson, DEPARTMENT OF HEALTH AND instructions for submitting comments.
Chief, Information Collection Review Office, HUMAN SERVICES Comments submitted electronically,
Office of Scientific Integrity, Office of the including attachments, to https://
Associate Director for Science, Office of the Food and Drug Administration www.regulations.gov will be posted to
Director, Centers for Disease Control and the docket unchanged. Because your
Prevention. [Docket No. FDA–2017–N–4625]
comment will be made public, you are
[FR Doc. 2017–18814 Filed 9–5–17; 8:45 am] solely responsible for ensuring that your
Development of a List of Pre-Dietary
BILLING CODE 4163–18–P Supplement Health and Education Act comment does not include any
Dietary Ingredients; Public Meeting; confidential information that you or a
Request for Comments third party may not wish to be posted,
DEPARTMENT OF HEALTH AND such as medical information, your or
HUMAN SERVICES AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
HHS. confidential business information, such
Food and Drug Administration ACTION: Notice of public meeting; as a manufacturing process. Please note
request for comments. that if you include your name, contact
[Docket No. FDA–2017–N–4642] information, or other information that
SUMMARY: The Food and Drug
identifies you in the body of your
B. Braun Medical, Inc.; Withdrawal of Administration (FDA or we) is
comments, that information will be
Approval of Three New Drug announcing the following public
posted on https://www.regulations.gov.
Applications and One Abbreviated New meeting entitled ‘‘Development of a List
• If you want to submit a comment
Drug Application; Correction of Pre-DSHEA Dietary Ingredients.’’ The
with confidential information that you
purpose of the meeting is to give
AGENCY: Food and Drug Administration, do not wish to be made available to the
interested stakeholders an opportunity
HHS. public, submit the comment as a
to discuss issues related to FDA’s future
written/paper submission and in the
ACTION: Notice; correction. development of such a list.
manner detailed (see ‘‘Written/Paper
DATES: The public meeting will be held Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug on October 3, 2017, from 8 a.m. to 5
Administration (FDA) is correcting a p.m. Submit either electronic or written Written/Paper Submissions
document entitled ‘‘B. Braun Medical, comments on this public meeting by Submit written/paper submissions as
Inc.; Withdrawal of Approval of Three December 4, 2017. See the follows:
New Drug Applications and One SUPPLEMENTARY INFORMATION section for • Mail/Hand delivery/Courier (for
Abbreviated New Drug Application’’ registration date and information. written/paper submissions): Dockets
that appeared in the Federal Register of ADDRESSES: The public meeting will be Management Staff (HFA–305), Food and
August 3, 2017 (82 FR 36150). The held at FDA’s Center for Food Safety Drug Administration, 5630 Fishers
document was published with the and Applied Nutrition, Wiley Lane, Rm. 1061, Rockville, MD 20852.
incorrect docket number. This Auditorium, 5001 Campus Dr., College • For written/paper comments
document corrects that error. Park, MD 20740. submitted to the Dockets Management
FOR FURTHER INFORMATION CONTACT: Lisa You may submit comments as Staff, FDA will post your comment, as
Granger, Office of Policy, Food and Drug follows. Please note that late, untimely well as any attachments, except for
Administration, Bldg. 32, Rm. 3330, filed comments will not be considered. information submitted, marked and
Silver Spring, MD 20993–0002, 301– Electronic comments must be submitted identified, as confidential, if submitted
796–9115. on or before December 4, 2017. The as detailed in ‘‘Instructions.’’
SUPPLEMENTARY INFORMATION: In the https://www.regulations.gov electronic Instructions: All submissions received
Federal Register of Thursday, August 3, filing system will accept comments must include the Docket No. FDA–
2017, in FR Doc. 2017–16377, on page until midnight Eastern Time at the end 2017–N–4625 for ‘‘Development of a
36150, the following correction is made: of December 4, 2017. Comments List of Pre-DSHEA Dietary Ingredients;
1. On page 36150, in the second received by mail/hand delivery/courier Public Meeting; Request for Comments.’’
column, in the header of the document, (for written/paper submissions) will be Received comments, those filed in a
‘‘Docket No. FDA–2017–N–0002’’ is considered timely if they are timely manner (see ADDRESSES), will be
asabaliauskas on DSKBBXCHB2PROD with NOTICES
corrected to read ‘‘Docket No. FDA– postmarked or the delivery service placed in the docket and, except for
2017–N–4642’’. acceptance receipt is on or before that those submitted as ‘‘Confidential
date. Submissions,’’ publicly viewable at
Dated: August 28, 2017. https://www.regulations.gov or at the
Anna K. Abram, Electronic Submissions Dockets Management Staff between 9
Deputy Commissioner for Policy, Planning, Submit electronic comments in the a.m. and 4 p.m., Monday through
Legislation, and Analysis. following way: Friday.
[FR Doc. 2017–18813 Filed 9–5–17; 8:45 am] • Federal eRulemaking Portal: • Confidential Submissions—To
BILLING CODE 4164–01–P https://www.regulations.gov. Follow the submit a comment with confidential
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Document Created: 2017-09-06 00:56:39
Document Modified: 2017-09-06 00:56:39
| 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; correction. | |
| Contact | Lisa Granger, Office of Policy, Food and Drug Administration, Bldg. 32, Rm. 3330, Silver Spring, MD 20993- 0002, 301-796-9115. | |
| FR Citation | 82 FR 42098 |
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