Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Proposed Rules 65589 

Comments: Regardless of attendance 

at the public meeting, interested persons 

may submit electronic comments to 

http://www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with Docket No. 

FDA–2013–N–0260, which has 

previously been established to accept 

comments regarding this issue. In order 

to receive consideration in advance of 

the delivery of the report (discussed 

further in this document), comments 

must be received by December 16, 2013. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday, and will be posted to 

the docket at http://

www.regulations.gov. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Send 

written requests to the Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, President Obama 

signed FDASIA (Pub. L. 112–144) into 

law. Section 1112(a) of FDASIA 

provides that not later than 18 months 

after its enactment, the Secretary, after 

obtaining input from medical gas 

manufacturers and any other interested 

members of the public, shall determine 

whether any changes to the Federal drug 

regulations are necessary for medical 

gases and submit a report regarding any 

such changes to the Committee on 

Health, Education, Labor, and Pensions 

of the U.S. Senate and the Committee on 

Energy and Commerce of the U.S. House 

of Representatives. Section 1112(c)(1) 

defines ‘‘Federal drug regulations’’ to 

mean ‘‘regulations in title 21 of the Code 

of Federal Regulations pertaining to 

drugs.’’ Section 1112(b) provides that if 

the Secretary determines that changes to 

the Federal drug regulations are 

necessary for medical gases, the 

Secretary shall issue final regulations 

revising the Federal drug regulations 

with respect to medical gases not later 

than 48 months after the enactment of 

FDASIA. 

On March 22, 2013, FDA issued a 

Federal Register notice (78 FR 17611), 

which established a public docket 

(Docket No. FDA–2013–N–0260) to 

request comments from medical gas 

manufacturers and any other interested 

members of the public on whether any 

changes to Federal drug regulations are 

necessary for medical gases. 

II. Purpose and Scope of the Meeting 

We are holding this meeting to 

provide an additional opportunity for 

medical gas manufacturers and any 

other interested members of the public 

to provide input on whether any 

changes to Federal drug regulations are 

needed for medical gases. 

Dated: October 28, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–26056 Filed 10–31–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 226 

[BIA–2013–0003; 134/A0A511010/

AAK1001000] 

RIN 1076–AF17 

Leasing of Osage Reservation Lands 

for Oil and Gas Mining 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Proposed rule; Reopening of 

comment period. 

SUMMARY: In August, the Bureau of 

Indian Affairs (BIA) published a 

proposed rule in the Federal Register to 

revise regulations addressing oil and gas 

mining on reservation land of the Osage 

Nation. The public comment period for 

that rule closed on October 28, 2013. 

This notice reopens the comment period 

until November 18, 2013. 

DATES: Comments on the proposed rule 

published August 28, 2013 (78 FR 

53083) must be received by November 

18, 2013. 

ADDRESSES: You may submit comments 

by any of the following methods: 

—Federal rulemaking portal: The rule is 

listed under the agency name ‘‘Bureau 

of Indian Affairs’’ and has been 

assigned Docket ID ‘‘BIA–2013–0003’’ 

at http://www.regulations.gov. 

—Email: osageregneg@bia.gov. Include 

the number 1076–AF17 in the subject 

line of the message. 

—Mail or hand-delivery: Mr. Eddie 

Streater, Designated Federal Officer, 

Bureau of Indian Affairs, P.O. Box 

8002, Muscogee, OK 74402. Include 

the number 1076–AF17 on the outer 

envelope. 

We cannot ensure that comments 

received after the close of the comment 

period (see DATES) will be included in 

the docket for this rulemaking and 

considered. Comments sent to an 

address other than those listed above 

will not be included in the docket for 

this rulemaking. 

Comments on the information 

collections contained in this proposed 

regulation are separate from those on 

the substance of the rule. Send 

comments on the information collection 

burden to OMB by facsimile to (202) 

395–5806 or email to the OMB Desk 

Officer for the Department of the 

Interior at OIRA_submission@

omb.eop.gov. Please send a copy of your 

comments to the person listed in the 

FOR FURTHER INFORMATION CONTACT

section of this notice. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Eddie Streater, Designated Federal 

Officer, Bureau of Indian Affairs, P.O. 

Box 8002, Muscogee, OK 74402; 

telephone: (918) 781–4608; fax: (918) 

718–4604; or email: osageregneg@

bia.gov. Additional information can be 

found at: http://www.bia.gov/

osageregneg. 

SUPPLEMENTARY INFORMATION: On August 

28, 2013, BIA published a proposed rule 

revising 25 CFR 226 (78 FR 53083). The 

proposed rule is the result of a 

negotiated rulemaking and would 

update the leasing procedures and 

rental, production, and royalties 

requirements for oil and gas on Osage 

Mineral lands. The comment period for 

the proposed rule closed October 28, 

2013. With this notice, BIA is reopening 

the comment period and establishing a 

new comment deadline of November 18, 

2013. 

BIA will also consider any comments 

that it received between the close of the 

original comment period on October 28, 

2013, and the reopening of the comment 

period. If you submitted comments 

during this period, there is no need to 

resubmit them. 

Dated: October 25, 2013. 

Kevin K. Washburn, 

Assistant Secretary—Indian Affairs. 

[FR Doc. 2013–25848 Filed 10–31–13; 8:45 am] 

BILLING CODE 4310–02–P 


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