Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal, 19936 [2018-09589]

Download as PDF 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 SUMMARY: The direct final rule published at January 26, 2018 (83 FR 3586), is withdrawn effective May 7, 2018.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delegated to the Commissioner of Food and Drugs, the direct final rule published on January 26, 2018 (83 FR 3586) is withdrawn.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] daltland on DSKBBV9HB2PROD with RULES BILLING CODE 4164–01–P VerDate Sep<11>2014 16:29 May 04, 2018 Jkt 244001 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 Sfmt 4700 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 E:\FR\FM\07MYR1.SGM 07MYR1

Agencies

[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.

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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
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