Document ID: FDA-2015-N-1355-0026
Agency: fda
Document Type: Rule
Title: Use of Ozone-Depleting Substances
Posted Date: 2017-02-28T05:00Z

[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Rules and Regulations]
[Pages 12067-12068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03866]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2015-N-1355]
RIN 0910-AH36

Use of Ozone-Depleting Substances

AGENCY: Food and Drug Administration, HHS.

[[Page 12068]]

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: In accordance with a determination by the Director of the 
Office of Management and Budget (OMB) that the direct final rule (``Use 
of Ozone Depleting Substances'') published on October 26, 2016, is 
excluded from the memorandum of January 20, 2017, from the Assistant to 
the President and Chief of Staff, entitled ``Regulatory Freeze Pending 
Review,'' this action confirms the effective date of February 23, 2017, 
for the direct final rule.

DATES: The effective date of the direct final rule that published on 
October 26, 2016, at 81 FR 74298, is confirmed to be February 23, 2017.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, 
daniel.orr@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On October 26, 2016, the Food and Drug 
Administration (FDA or Agency) issued a direct final rule amending the 
regulation on uses of ozone-depleting substances (ODSs), including 
chlorofluorocarbons, to remove the designations for sterile aerosol 
talc administered intrapleurally by thoracoscopy for human use and 
metered-dose atropine sulfate aerosol human drugs administered by oral 
inhalation as ``essential uses'' under the Clean Air Act. FDA took this 
action because alternative products that do not use ODSs are now 
available, and because these products are no longer being marketed in 
versions that contain ODSs. FDA did not receive any significant adverse 
comments regarding the direct final rule, which was published with an 
effective date of February 23, 2017.
    A memorandum of January 20, 2017 (82 FR 8346), from the Assistant 
to the President and Chief of Staff, entitled ``Regulatory Freeze 
Pending Review,'' directed the heads of Executive Departments and 
Agencies to temporarily postpone for 60 days from the date of the 
memorandum the effective dates of all regulations that had been 
published in the Federal Register but had not yet taken effect, for the 
purpose of ``reviewing questions of fact, law, and policy they raise.'' 
The memorandum also stated that the Director of OMB may exclude certain 
regulations if they ``affect critical health, safety, financial, or 
national security matters, or for some other reason.'' Pursuant to the 
memorandum, the Director of OMB has excluded the direct final rule that 
published on October 26, 2016, at 81 FR 74298, from the directive to 
delay the effective date of certain regulations. The Department, 
therefore, confirms that the effective date of the direct final rule is 
February 23, 2017.

    Dated: February 22, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-03866 Filed 2-27-17; 8:45 am]
 BILLING CODE 4164-01-P