Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 78749 

under the Paperwork Reduction Act of 

1995 (the PRA) (44 U.S.C. 3501–3520). 

Rather, the requirement to label HCT/Ps 

in accordance with the proposed rule is 

a ‘‘public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)). Therefore, FDA 

tentatively concludes that these 

proposed requirements in this 

document are not subject to review by 

OMB because they do not constitute a 

‘‘collection of information’’ under the 

PRA. 

IX. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. 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. 

List of Subjects in 21 CFR Part 1271 

Biologics, Drugs, Human cells and 

tissue-based products, Medical devices, 

Reporting and recordkeeping 

requirements. 

Therefore, under the Public Health 

Service Act and under the authority 

delegated to the Commissioner of Food 

and Drugs, it is proposed that 21 CFR 

part 1271 be amended as follows: 

PART 1271—HUMAN CELLS, TISSUES, 

AND CELLULAR AND TISSUE-BASED 

PRODUCTS 

■ 1. The authority citation for 21 CFR 

part 1271 continues to read as follows: 

Authority: 42 U.S.C. 216, 243, 263a, 264, 

271. 

■ 2. In § 1271.90: 

■ a. Revise the heading; 

■ b. Revise paragraphs (a)(3) and (a)(4) 

by removing ‘‘exempt’’ and by adding in 

its place ‘‘excepted’’; 

■ c. Revise paragraph (a)(4) by removing 

‘‘paragraph’’ and by adding in its place 

‘‘paragraphs ’’; and by adding ‘‘(a)(1) 

and’’ before ‘‘(a)(2)’’; 

■ d. Redesignate paragraph (b) as 

paragraph (c); 

■ e. Add a new paragraph (b); 

■ f. Revise newly designated paragraph 

(c) by removing ‘‘paragraph’’ and by 

adding in its place ‘‘paragraphs’’ and by 

adding ‘‘and (b)’’ after ‘‘(a)’’ in the 

introductory text; 

■ g. Revise newly designated paragraph 

(c)(2) by removing ‘‘(b)(6)’’ and by 

adding in its place ‘‘(c)(6)’’; and 

■ h. Revise newly designated paragraph 

(c)(6) by adding ‘‘recovery or’’ before 

‘‘cryopreservation’’. 

The revisions read as follows: 

§ 1271.90 Are there other exceptions and 

what labeling requirements apply? 

(a) * * * 

(3) Cryopreserved cells or tissue for 

reproductive use, other than embryos, 

originally excepted under paragraphs 

(a)(1) or (a)(2) of this section at the time 

of donation, that are subsequently 

intended for directed donation, 

provided that 

* * * * * 

(4) A cryopreserved embryo, 

originally excepted under paragraphs 

(a)(1) and (a)(2) of this section at the 

time of cryopreservation, that is 

subsequently intended for directed or 

anonymous donation. When possible, 

appropriate measures should be taken to 

screen and test the semen and oocyte 

donors before transfer of the embryo to 

the recipient. 

(b) Exceptions for Reproductive Use. 

An embryo originally intended for 

reproductive use for a specific 

individual or couple that is 

subsequently intended for directed or 

anonymous donation for reproductive 

use is excepted from the prohibition on 

use under § 1271.45(c) even when the 

applicable donor eligibility 

requirements under part 1271, subpart C 

are not met. Nothing in this paragraph 

creates an exception for deficiencies 

that occurred in making the donor 

eligibility determination for either the 

oocyte donor or the semen donor as 

required under § 1271.45(b), or for 

deficiencies in performing donor 

screening or testing, as required under 

§§ 1271.75, 1271.80, and 1271.85. 

(c) Required labeling. As applicable, 

you must prominently label an HCT/P 

described in paragraphs (a) and (b) of 

this section as follows: 

(1) * * * 

(2) ‘‘NOT EVALUATED FOR 

INFECTIOUS SUBSTANCES,’’ unless 

you have performed all otherwise 

applicable screening and testing under 

§§ 1271.75, 1271.80, and 1271.85. This 

paragraph does not apply to 

reproductive cells or tissue labeled in 

accordance with paragraph (c)(6) of this 

section. 

* * * * * 

(6) ‘‘Advise recipient that screening 

and testing of the donor(s) were not 

performed at the time of recovery or 

cryopreservation of the reproductive 

cells or tissue, but have been performed 

subsequently,’’ for paragraphs (a)(3) or 

(a)(4) of this section. 

* * * * * 

■ 3. Amend § 1271.370(b)(4) by 

removing ‘‘§ 1271.90(b)’’ and by adding 

in its place ‘‘§ 1271.90(c)’’. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30528 Filed 12–30–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF LABOR 

Mine Safety and Health Administration 

30 CFR Part 100 

[Docket No. MSHA–2014–0009] 

RIN 1219–AB72 

Criteria and Procedures for 

Assessment of Civil Penalties 

AGENCY: Mine Safety and Health 

Administration, Labor. 

ACTION: Proposed rule; notice of public 

hearings; extension of comment period; 

close of record. 

SUMMARY: The Mine Safety and Health 

Administration (MSHA) will hold two 

additional public hearings on the 

Agency’s proposed rule for Criteria and 

Procedures for Assessment of Civil 

Penalties. 

DATES: MSHA will hold public hearings 

on February 5, 2015, and February 12, 

2015, at the locations listed in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Post-hearing comments must be 

received or postmarked by midnight 

Eastern Standard Time on March 12, 

2015. 

ADDRESSES: Submit comments, 

informational materials, and requests to 

speak, identified by RIN 1219–AB72 or 

Docket No. MSHA–2014–0009, by one 

of the following methods: 

• Federal E-Rulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

• E-Mail: zzMSHA-comments@

dol.gov. Include RIN 1219–AB72 or 

Docket No. MSHA–2014–0009 in the 

subject line of the message. 

• Mail: MSHA, Office of Standards, 

Regulations, and Variances, 1100 

Wilson Boulevard, Room 2350, 

Arlington, Virginia 22209–3939. 

• Hand Delivery or Courier: MSHA, 

1100 Wilson Boulevard, Room 2350, 

Arlington, Virginia, between 9:00 a.m. 

and 5:00 p.m., Monday through Friday, 


tkelley on DSK3SPTVN1PROD with PROPOSALS
78750 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Proposed Rules 

except Federal holidays. Sign in at the 

receptionist’s desk on the 21st floor. 

• Fax: 202–693–9441. 

Instructions: All submissions must 

include ‘‘MSHA’’ and ‘‘RIN 1219– 

AB72’’ or ‘‘Docket No. MSHA–2014– 

0009.’’ Do not include personal 

information that you do not want 

publicly disclosed; MSHA will post all 

comments without change to http://

www.regulations.gov and http://

www.msha.gov/currentcomments.asp, 

including any personal information 

provided. For additional instructions for 

participation in Public Hearings on this 

rulemaking, see the ‘‘Public Hearings’’ 

heading of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: For access to the docket to 

read comments received, go to http://

www.regulations.gov or http://

www.msha.gov/currentcomments.asp. 

To read background documents, go to 

http://www.regulations.gov. Review the 

docket in person at MSHA, Office of 

Standards, Regulations, and Variances, 

1100 Wilson Boulevard, Room 2350, 

Arlington, Virginia, between 9:00 a.m. 

and 5:00 p.m. Monday through Friday, 

except Federal Holidays. Sign in at the 

receptionist’s desk on the 21st floor. 

Email notification: To subscribe to 

receive an email notification when 

MSHA publishes rules, program 

information, instructions, and policy, in 

the Federal Register, go to http://

www.msha.gov/subscriptions/

subscribe.aspx. 

FOR FURTHER INFORMATION CONTACT: 

Sheila McConnell, Acting Director, 

Office of Standards, Regulations, and 

Variances, MSHA, at 

mcconnell.sheila.a@dol.gov (email); 

202–693–9440 (voice); or 202–693–9441 

(facsimile). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 31, 2014, MSHA published a 

proposed rule (79 FR 44494) to amend 

its civil penalty regulation to simplify 

the criteria, which will promote 

consistency, objectivity, and efficiency 

in the proposed assessment of civil 

penalties and facilitate the resolution of 

enforcement issues. The proposal would 

place a greater emphasis on the more 

serious safety and health conditions and 

provide improved safety and health for 

miners. MSHA is also proposing 

alternatives that would address the 

scope and applicability of its civil 

penalty regulation. 

In response to requests from the 

public, MSHA held public hearings on 

December 4, 2014, in Arlington, 

Virginia, and on December 9, 2014, in 

Denver, Colorado. The post-hearing 

comment period was scheduled to close 

on January 9, 2015. 

II. Public Hearings 

In response to requests from the 

public, MSHA will hold two additional 

public hearings on the proposed rule to 

provide the public an opportunity to 

present their views on this rulemaking. 

MSHA is holding the hearings on the 

following dates at the locations 

indicated: 

Date Location Contact No. 

Thursday, February 5, 2015 .................... Sheraton Birmingham Hotel, 2101 Richard Arrington Jr. Boulevard North, Birmingham, AL 35203.205–324–5000 

Thursday, February 12, 2015 .................. Embassy Suites Chicago—Downtown, 600 N. State Street, Chicago, IL 60654 ..... 312–943–3800 

The hearings will begin with an 

opening statement from MSHA, 

followed by oral presentations from 

members of the public. The public 

hearings will begin at 9:00 a.m. and end 

no later than 5:00 p.m., or earlier if the 

last person presenting testimony has 

spoken. 

Persons and organizations wishing to 

speak are encouraged to notify MSHA in 

advance for scheduling purposes. 

Persons do not have to make a written 

request to speak; however, MSHA will 

give priority to persons who have 

notified us, in advance, of their intent 

to speak and will provide others an 

opportunity to present oral testimony if 

time allows. MSHA requests that parties 

making presentations at the hearings 

submit them no later than five days 

prior to the hearing. Testimony, 

presentations, and accompanying 

documentation will be included in the 

rulemaking record. 

The hearings will be conducted in an 

informal manner. Formal rules of 

evidence and cross examination will not 

apply. The hearing panel may ask 

questions of speakers and speakers may 

ask questions of the hearing panel. 

Verbatim transcripts of the proceedings 

will be prepared and made a part of the 

rulemaking record. Copies of the 

transcripts will be available to the 

public on http://www.regulations.gov 

and on MSHA’s Web site at http://

www.msha.gov/tscripts.htm. 

Commenters are requested to be 

specific in their comments and submit 

detailed rationale and supporting 

documentation for any comment or 

suggested alternative as MSHA cannot 

sufficiently evaluate general comments. 

All comments must be received or 

postmarked by March 12, 2015. 

Dated: December 23, 2014. 

Joseph A. Main, 

Assistant Secretary of Labor for Mine Safety 

and Health. 

[FR Doc. 2014–30578 Filed 12–30–14; 8:45 am] 

BILLING CODE 4510–43–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 50, 51, 52, 53, and 58 

[EPA–HQ–OAR–2008–0699; FRL–9921–26– 

OAR] 

RIN 2060–AP38 

National Ambient Air Quality 

Standards for Ozone 

AGENCY: Environmental Protection 

Agency. 

ACTION: Announcement of public 

hearings. 

SUMMARY: The Environmental Protection 

Agency (EPA) is announcing three 

public hearings for the proposed rule 

titled, ‘‘National Ambient Air Quality 

Standards for Ozone,’’ that was 

published in the Federal Register on 

December 17, 2014. The hearings will be 

held in Washington, DC, Arlington, 

Texas, and Sacramento, California. 

Based on its review of the air quality 

criteria for ozone (O3) and related 

photochemical oxidants and national 

ambient air quality standards (NAAQS) 

for O3, the EPA proposes to make 

revisions to the primary and secondary 

NAAQS for O3 to provide requisite 


tkelley on DSK3SPTVN1PROD with PROPOSALS