83 FR 19936 - Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 88 (May 7, 2018)

Page Range		19936-19936
FR Document		2018-09589

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.

Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018)

[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Page 19936]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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3586), is withdrawn effective May 7, 2018.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3586) is withdrawn.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

19936 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Rules and Regulations

DEPARTMENT OF HEALTH AND DEPARTMENT OF LABOR comments for this rulemaking. After
HUMAN SERVICES accessing ‘‘all documents and
Occupational Safety and Health comments’’ in the docket (OSHA–2018–
Food and Drug Administration Administration 0003), check the ‘‘Rule’’ box in the
column headed ‘‘Document Type,’’ find
21 CFR Part 600 29 CFR Part 1910 the document posted on the date of
[Docket No. OSHA–2018–0003]
publication of this document, and click
[Docket No. FDA–2017–N–7007]
the ‘‘Submit a Comment’’ link.
RIN 1218–AB76 Additional instructions for submitting
comments are available from the http://
RIN 0910–AH49 Revising the Beryllium Standard for www.regulations.gov homepage.
General Industry Facsimile: OSHA allows facsimile
Removal of Certain Time of Inspection transmission of comments that are 10
and Duties of Inspector Regulations AGENCY: Occupational Safety and Health
Administration (OSHA), Department of pages or fewer in length (including
for Biological Products; Withdrawal attachments). Fax these documents to
Labor.
the OSHA Docket Office at (202) 693–
AGENCY: Food and Drug Administration, ACTION: Direct final rule; request for
1648. OSHA does not require hard
HHS. comment.
copies of these documents. Instead of
ACTION: Direct final rule; withdrawal. SUMMARY: On January 9, 2017, the transmitting facsimile copies of
Occupational Safety and Health attachments that supplement these
SUMMARY: The Food and Drug Administration (OSHA) issued a final documents (e.g., studies, journal
rule adopting a comprehensive general articles), commenters must submit these
Administration (FDA) published in the
industry standard for exposure to attachments to the OSHA Docket Office,
Federal Register of January 26, 2018, a
beryllium and beryllium compounds. In Docket No. OSHA–2018–0003,
direct final rule to amend the general Occupational Safety and Health
biologics regulations relating to time of this Direct Final Rule (DFR), OSHA is
adopting a number of clarifying Administration, U.S. Department of
inspection requirements and to also Labor, Room N–3653, 200 Constitution
remove duties of inspector amendments to address the application
of the standard to materials containing Avenue NW, Washington, DC 20210.
requirements. The comment period These attachments must clearly identify
trace amounts of beryllium. OSHA
closed April 11, 2018. FDA is the sender’s name, the date, the subject,
believes this rule will maintain safety
withdrawing the direct final rule and health protections for workers and the docket number (OSHA–2018–
because the Agency received significant while reducing the burden to employers 0003) so that the Docket Office can
adverse comment. of complying with the current rule. attach them to the appropriate
document.
DATES: The direct final rule published at DATES: This DFR will become effective
Regular mail, express delivery, hand
January 26, 2018 (83 FR 3586), is on July 6, 2018 unless significant delivery, and messenger (courier)
withdrawn effective May 7, 2018. adverse comment is submitted service: Submit comments and any
(transmitted, postmarked, or delivered) additional material to the OSHA Docket
FOR FURTHER INFORMATION CONTACT:
by June 6, 2018. If DOL receives Office, Docket No. OSHA–2018–0003,
Melissa Segal, Center for Biologics significant adverse comment, the
Evaluation and Research, Food and Occupational Safety and Health
Agency will publish a timely Administration, U.S. Department of
Drug Administration, 10903 New withdrawal in the Federal Register
Hampshire Ave., Bldg. 71, Rm. 7301, Labor, Room N–3653, 200 Constitution
informing the public that this DFR will Avenue NW, Washington, DC 20210;
Silver Spring, MD 20993–0002, 240– not take effect (see Section III, ‘‘Direct telephone: (202) 693–2350. (OSHA’s
402–7911. Final Rulemaking,’’ for more details on TTY number is (877) 889–5627.) Contact
SUPPLEMENTARY INFORMATION: Therefore, this process). Comments to this DFR, the OSHA Docket Office for information
under the Federal Food, Drug, and hearing requests, and other information about security procedures concerning
must be submitted (transmitted, delivery of materials by express
Cosmetic Act, and under authority
postmarked, or delivered) by June 6, delivery, hand delivery, and messenger
delegated to the Commissioner of Food
2018. All submissions must bear a service. The Docket Office will accept
and Drugs, the direct final rule
postmark or provide other evidence of deliveries (express delivery, hand
published on January 26, 2018 (83 FR the submission date.
3586) is withdrawn. delivery, messenger service) during the
ADDRESSES: The public can submit Docket Office’s normal business hours,
Dated: May 1, 2018. comments, hearing requests, and other 10:00 a.m. to 3:00 p.m., ET.
Leslie Kux, material, identified by Docket No. Instructions: All submissions must
Associate Commissioner for Policy. OSHA–2018–0003, using any of the include the Agency’s name, the title of
[FR Doc. 2018–09589 Filed 5–4–18; 8:45 am] following methods: the rulemaking (Beryllium Standard:
Electronically: Submit comments and Direct Final Rule), and the docket
BILLING CODE 4164–01–P
attachments, as well as hearing requests number (OSHA–2018–0003). OSHA will
and other information, electronically at place comments and other material,
http://www.regulations.gov, which is including any personal information, in
the Federal e-Rulemaking Portal. Follow the public docket without revision, and
the instructions online for submitting the comments and other material will be
daltland on DSKBBV9HB2PROD with RULES

comments. Note that this docket may available online at http://
include several different Federal www.regulations.gov. Therefore, OSHA
Register notices involving active cautions commenters about submitting
rulemakings, so it is extremely statements they do not want made
important to select the correct notice or available to the public, or submitting
its ID number when submitting comments that contain personal

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Document Created: 2018-05-05 02:48:24
Document Modified: 2018-05-05 02:48:24

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		Rules and Regulations
Action		Direct final rule; withdrawal.
Dates		The direct final rule published at January 26, 2018 (83 FR 3586), is withdrawn effective May 7, 2018.
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.
FR Citation		83 FR 19936
RIN Number		0910-AH49

83 FR 19936 - Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 88 (May 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration