Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal, 19936 [2018-09589]
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19936
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF LABOR
Food and Drug Administration
Occupational Safety and Health
Administration
21 CFR Part 600
29 CFR Part 1910
[Docket No. OSHA–2018–0003]
[Docket No. FDA–2017–N–7007]
RIN 1218–AB76
Revising the Beryllium Standard for
General Industry
RIN 0910–AH49
Removal of Certain Time of Inspection
and Duties of Inspector Regulations
for Biological Products; Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) published in the
Federal Register of January 26, 2018, a
direct final rule to amend the general
biologics regulations relating to time of
inspection requirements and to also
remove duties of inspector
requirements. The comment period
closed April 11, 2018. FDA is
withdrawing the direct final rule
because the Agency received significant
adverse comment.
SUMMARY:
The direct final rule published at
January 26, 2018 (83 FR 3586), is
withdrawn effective May 7, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Melissa Segal, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
Therefore,
under the Federal Food, Drug, and
Cosmetic Act, and under authority
delegated to the Commissioner of Food
and Drugs, the direct final rule
published on January 26, 2018 (83 FR
3586) is withdrawn.
Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–09589 Filed 5–4–18; 8:45 am]
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On January 9, 2017, the
Occupational Safety and Health
Administration (OSHA) issued a final
rule adopting a comprehensive general
industry standard for exposure to
beryllium and beryllium compounds. In
this Direct Final Rule (DFR), OSHA is
adopting a number of clarifying
amendments to address the application
of the standard to materials containing
trace amounts of beryllium. OSHA
believes this rule will maintain safety
and health protections for workers
while reducing the burden to employers
of complying with the current rule.
DATES: This DFR will become effective
on July 6, 2018 unless significant
adverse comment is submitted
(transmitted, postmarked, or delivered)
by June 6, 2018. If DOL receives
significant adverse comment, the
Agency will publish a timely
withdrawal in the Federal Register
informing the public that this DFR will
not take effect (see Section III, ‘‘Direct
Final Rulemaking,’’ for more details on
this process). Comments to this DFR,
hearing requests, and other information
must be submitted (transmitted,
postmarked, or delivered) by June 6,
2018. All submissions must bear a
postmark or provide other evidence of
the submission date.
ADDRESSES: The public can submit
comments, hearing requests, and other
material, identified by Docket No.
OSHA–2018–0003, using any of the
following methods:
Electronically: Submit comments and
attachments, as well as hearing requests
and other information, electronically at
https://www.regulations.gov, which is
the Federal e-Rulemaking Portal. Follow
the instructions online for submitting
comments. Note that this docket may
include several different Federal
Register notices involving active
rulemakings, so it is extremely
important to select the correct notice or
its ID number when submitting
SUMMARY:
Direct final rule; withdrawal.
SUPPLEMENTARY INFORMATION:
Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Direct final rule; request for
comment.
AGENCY:
PO 00000
Frm 00032
Fmt 4700
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comments for this rulemaking. After
accessing ‘‘all documents and
comments’’ in the docket (OSHA–2018–
0003), check the ‘‘Rule’’ box in the
column headed ‘‘Document Type,’’ find
the document posted on the date of
publication of this document, and click
the ‘‘Submit a Comment’’ link.
Additional instructions for submitting
comments are available from the https://
www.regulations.gov homepage.
Facsimile: OSHA allows facsimile
transmission of comments that are 10
pages or fewer in length (including
attachments). Fax these documents to
the OSHA Docket Office at (202) 693–
1648. OSHA does not require hard
copies of these documents. Instead of
transmitting facsimile copies of
attachments that supplement these
documents (e.g., studies, journal
articles), commenters must submit these
attachments to the OSHA Docket Office,
Docket No. OSHA–2018–0003,
Occupational Safety and Health
Administration, U.S. Department of
Labor, Room N–3653, 200 Constitution
Avenue NW, Washington, DC 20210.
These attachments must clearly identify
the sender’s name, the date, the subject,
and the docket number (OSHA–2018–
0003) so that the Docket Office can
attach them to the appropriate
document.
Regular mail, express delivery, hand
delivery, and messenger (courier)
service: Submit comments and any
additional material to the OSHA Docket
Office, Docket No. OSHA–2018–0003,
Occupational Safety and Health
Administration, U.S. Department of
Labor, Room N–3653, 200 Constitution
Avenue NW, Washington, DC 20210;
telephone: (202) 693–2350. (OSHA’s
TTY number is (877) 889–5627.) Contact
the OSHA Docket Office for information
about security procedures concerning
delivery of materials by express
delivery, hand delivery, and messenger
service. The Docket Office will accept
deliveries (express delivery, hand
delivery, messenger service) during the
Docket Office’s normal business hours,
10:00 a.m. to 3:00 p.m., ET.
Instructions: All submissions must
include the Agency’s name, the title of
the rulemaking (Beryllium Standard:
Direct Final Rule), and the docket
number (OSHA–2018–0003). OSHA will
place comments and other material,
including any personal information, in
the public docket without revision, and
the comments and other material will be
available online at https://
www.regulations.gov. Therefore, OSHA
cautions commenters about submitting
statements they do not want made
available to the public, or submitting
comments that contain personal
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[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Page 19936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09589]
[[Page 19936]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 600
[Docket No. FDA-2017-N-7007]
RIN 0910-AH49
Removal of Certain Time of Inspection and Duties of Inspector
Regulations for Biological Products; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) published in the
Federal Register of January 26, 2018, a direct final rule to amend the
general biologics regulations relating to time of inspection
requirements and to also remove duties of inspector requirements. The
comment period closed April 11, 2018. FDA is withdrawing the direct
final rule because the Agency received significant adverse comment.
DATES: The direct final rule published at January 26, 2018 (83 FR
3586), is withdrawn effective May 7, 2018.
FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION: Therefore, under the Federal Food, Drug, and
Cosmetic Act, and under authority delegated to the Commissioner of Food
and Drugs, the direct final rule published on January 26, 2018 (83 FR
3586) is withdrawn.
Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09589 Filed 5-4-18; 8:45 am]
BILLING CODE 4164-01-P
