Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Proposed Rules 75527 

and must explain why the concerns 

underlying the request could not 

reasonably be addressed by other 

measures. If an exemption is granted, 

the applicant, manufacturer, or person 

responsible for the content of labeling of 

unapproved drugs must distribute the 

content of labeling in paper form. 

(2) For products regulated by the 

Center for Drug Evaluation and 

Research, requests for an exemption 

should be sent to the Office of New 

Drugs, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, or for 

drug products for which there is no 

reference listed drug, to the Office of 

Generic Drugs, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 7500 Standish Pl., 

Rockville, MD 20855. For products 

regulated by the Center for Biologics 

Evaluation and Research, requests for an 

exemption should be submitted to the 

attention of the appropriate Review 

Division in the relevant Center for 

Biologics Evaluation and Research 

Product Office using the following 

address: Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, Document Control 

Center, 1401 Rockville Pike (HFM–99), 

Rockville, MD 20852. 

■ 3. In § 201.306, revise paragraph 

(a)(1)(ii) introductory text and paragraph 

(b)(2) to read as follows: 

§ 201.306 Potassium salt preparations 

intended for oral ingestion by man. 

(a) * * * 

(1) * * * 

(ii) The labeling either on or within 

the package from which the drug is to 

be dispensed or accompanying the 

package from which the drug is to be 

dispensed under § 201.100(b)(8) bears 

adequate information for its use by 

practitioners in accord with the ‘‘full 

disclosure’’ labeling requirements of 

§ 201.100, including the following 

warning statement: * * * 

* * * * * 

(b) * * * 

(2) The labeling either on or within 

the package from which the drug is to 

be dispensed or accompanying the 

package from which the drug is to be 

dispensed under § 201.100(b)(8) bears 

adequate information for its use by 

practitioners in accord with the ‘‘full 

disclosure’’ labeling requirements of 

§ 201.100, including a recommendation 

that patients be directed to dissolve any 

such tablets in an appropriate amount of 

liquid and to dilute any such liquid 

preparations adequately to assure 

against gastrointestinal injury associated 

with the oral ingestion of concentrated 

potassium salt preparations. 

■ 4. In § 201.310, revise the third 

sentence of paragraph (a) to read as 

follows: 

§ 201.310 Phenindione; labeling of drug 

preparations intended for use by man. 

(a) * * * In view of the potentially 

serious effects found to be associated 

with preparations of this drug intended 

for use by man, the Commissioner of 

Food and Drugs will regard such 

preparations as misbranded within the 

meaning of section 502(f)(1) and (2) of 

the Federal Food, Drug, and Cosmetic 

Act, unless the label and labeling either 

on or within the package from which 

the drug is to be dispensed or 

accompanying the package from which 

the drug is to be dispensed under 

§ 201.100(b)(8), and any other labeling 

furnishing or purporting to furnish 

information for use of the drug, bear a 

conspicuous warning statement to the 

following effect: * * * 

* * * * * 

PART 606—CURRENT GOOD 

MANUFACTURING PRACTICE FOR 

BLOOD AND BLOOD COMPONENTS 

■ 5. The authority citation for 21 CFR 

part 606 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 

263a, 264. 

■ 6. In § 606.121 revise paragraph 

(c)(8)(ii) to read as follows: 

§ 606.121 Container label. 

* * * * * 

(c) * * * 

(8) * * * 

(ii) ‘‘See circular of information for 

indications, contraindications, cautions, 

and methods of infusion. To obtain the 

current circular of information, go to 

labels.fda.gov, or call (insert toll-free 

telephone number) for a faxed, emailed, 

or mailed copy.’’ This statement must be 

no smaller than 6-point type. 

* * * * * 

§ 606.122 [Amended] 

■ 7. In § 606.122 introductory text, 

remove the words ‘‘must be available for 

distribution’’ and add in their place 

‘‘must be distributed electronically.’’ 

PART 610—GENERAL BIOLOGICAL 

PRODUCTS STANDARDS 

■ 8. The authority citation for 21 CFR 

part 610 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360c, 360d, 360h, 360i, 371, 

372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 

264. 

■ 9. In § 610.60, add paragraph (a)(8) to 

read as follows: 

§ 610.60 Container label. 

(a) * * * 

(8) The container label for biological 

products must bear the statement: ‘‘To 

obtain the current prescribing 

information, go to labels.fda.gov, or call 

(insert the toll-free telephone number) 

for a faxed, emailed, or mailed copy.’’ 

This statement must be no smaller than 

6-point type. If the container label is 

incapable of bearing the statement due 

to inadequate space, the statement must 

be affixed to the container by other 

means, such as a peel-back label. 

* * * * * 

■ 10. In § 610.61, revise paragraphs (k) 

and (n) and add paragraph (t) to read as 

follows: 

§ 610.61 Package label. 

* * * * * 

(k) The route of administration 

recommended, or reference to such 

directions in an enclosed circular or the 

electronic prescribing information; 

* * * * * 

(n) The inactive ingredients when a 

safety factor, or reference to an enclosed 

circular or the electronic prescribing 

information; 

* * * * * 

(t) The package label for products 

must bear the statement: ‘‘To obtain the 

current prescribing information, go to 

labels.fda.gov or call (insert the toll-free 

telephone number) for a faxed, emailed, 

or mailed copy.’’ This statement must be 

no smaller than 6-point type. 

Dated: December 11, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29522 Filed 12–16–14; 11:15 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2014–0661; FRL–9920–46– 

Region–5] 

Approval and Promulgation of Air 

Quality Implementation Plans; Indiana; 

Ozone and PM2.5 Standards 

AGENCY: Environmental Protection 

Agency. 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

submission by the State of Indiana as a 

revision to the Indiana State 

Implementation Plan (SIP). The 

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75528 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Proposed Rules 

1Title XXXIII of the PHS Act is codified at 42 

U.S.C. 300mm to 300mm–61. Those portions of the 

Zadroga Act found in Titles II and III of Public Law 

111–347 do not pertain to the WTC Health Program 

and are codified elsewhere. 

submitted regulations revise Indiana’s 

ambient air quality standards for ozone 

and particulate matter to be consistent 

with EPA’s 2008 ozone and 2012 fine 

particulate matter National Ambient Air 

Quality Standards. EPA is therefore 

approving these SIP revisions in 

accordance with the requirements of the 

Clean Air Act. In the Final Rules section 

of this Federal Register, EPA is 

approving the State’s SIP submittal as a 

direct final rule without prior proposal 

because the Agency views this as a 

noncontroversial submittal and 

anticipates no adverse comments. A 

detailed rationale for the approval is set 

forth in the direct final rule. If no 

adverse comments are received in 

response to this action, no further 

activity is contemplated. If EPA receives 

adverse comments, the direct final rule 

will be withdrawn and all public 

comments received will be addressed in 

a subsequent final rule based on this 

proposed rule. EPA will not institute a 

second comment period. Any parties 

interested in commenting on this action 

should do so at this time. 

DATES: Comments must be received on 

or before January 20, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2014–0661, by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: aburano.douglas@epa.gov. 

3. Fax: (312) 408–2279. 

4. Mail: Douglas Aburano, Chief, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

U.S. Environmental Protection Agency, 

77 West Jackson Boulevard, Chicago, 

Illinois 60604. 

5. Hand Delivery: Douglas Aburano, 

Chief, Attainment Planning and 

Maintenance Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office normal hours 

of operation, and special arrangements 

should be made for deliveries of boxed 

information. The Regional Office official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Please see the direct final rule which 

is located in the Rules section of this 

Federal Register for detailed 

instructions on how to submit 

comments. 

FOR FURTHER INFORMATION CONTACT: Eric 

Svingen, Environmental Engineer, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 353–4489, 

svingen.eric@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

Final Rules section of this Federal 

Register, EPA is approving the State’s 

SIP submittal as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this rule, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

Please note that if EPA receives adverse 

comment on an amendment, paragraph, 

or section of this rule and if that 

provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. For additional information, 

see the direct final rule which is located 

in the Rules section of this Federal 

Register. 

Dated: December 5, 2014. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2014–29587 Filed 12–17–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 88 

World Trade Center Health Program; 

Petition 006—Primary Biliary Cirrhosis; 

Finding of Insufficient Evidence 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Denial of petition for addition of 

a health condition. 

SUMMARY: On October 20, 2014, the 

Administrator of the World Trade 

Center (WTC) Health Program received 

a petition to add primary biliary 

cirrhosis (Petition 006) to the List of 

WTC-Related Health Conditions (List). 

The Administrator has not found 

sufficient scientific evidence to conduct 

an analysis of whether to add primary 

biliary cirrhosis to the List. Accordingly, 

the Administrator finds that insufficient 

evidence exists to request a 

recommendation of the WTC Health 

Program Scientific/Technical Advisory 

Committee (STAC), to publish a 

proposed rule, or to publish a 

determination not to publish a proposed 

rule. 

DATES: The Administrator of the WTC 

Health Program is denying this petition 

for the addition of a health condition as 

of December 18, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst, 1090 

Tusculum Ave., MS: C–46, Cincinnati, 

OH 45226; telephone (855)818–1629 

(this is a toll-free number); email 

NIOSHregs@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII 1 establishing the WTC 

Health Program within the Department 

of Health and Human Services (HHS). 

The WTC Health Program provides 

medical monitoring and treatment 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery, and 

cleanup workers who responded to the 

September 11, 2001, terrorist attacks in 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania (responders), 

and to eligible persons who were 

present in the dust or dust cloud on 

September 11, 2001 or who worked, 

resided, or attended school, childcare, 

or adult daycare in the New York City 

disaster area (survivors). 

All references to the Administrator of 

the WTC Health Program 

(Administrator) in this notice mean the 

Director of the National Institute for 

Occupational Safety and Health 

(NIOSH) or his or her designee. 

Pursuant to section 3312(a)(6)(B) of 

the PHS Act, interested parties may 

petition the Administrator to add a 

health condition to the List in 42 CFR 

88.1. Within 60 calendar days after 

receipt of a petition to add a condition 

to the List, the Administrator must take 

one of the following four actions 

described in section 3312(a)(6)(B) and 

42 CFR 88.17: (i) Request a 

recommendation of the STAC; (ii) 

publish a proposed rule in the Federal 

Register to add such health condition; 

(iii) publish in the Federal Register the 

Administrator’s determination not to 

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