Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73629 

of the listed controlled substances in 

bulk and to conduct analytical testing in 

support of the company’s primary 

manufacturing facility in West Deptford, 

New Jersey. The controlled substances 

manufactured in bulk at this facility will 

be distributed to the company’s 

customers. 

Dated: November 25, 2014. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2014–29117 Filed 12–10–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Manufacturer of Controlled 

Substances Registration: Sigma 

Aldrich Research Biochemicals, Inc. 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of registration. 

SUMMARY: Sigma Aldrich Research 

Biochemicals, Inc., applied to be 

registered as a manufacturer of certain 

basic classes of controlled substances. 

The DEA grants Sigma Aldrich Research 

Biochemicals, Inc. registration as a 

manufacturer of those controlled 

substances. 

SUPPLEMENTARY INFORMATION: By notice 

dated January 15, 2014, and published 

in the Federal Register on February 4, 

2014, 79 FR 6633, Sigma Aldrich 

Research Biochemicals, Inc. 1–3 

Strathmore Road, Natick, Massachusetts 

01760–2447, applied to be registered as 

a manufacturer of certain basic classes 

of controlled substances. No comments 

or objections were submitted to this 

notice. 

The Drug Enforcement 

Administration (DEA) has considered 

the factors in 21 U.S.C. 823(a) and 

determined that the registration of 

Sigma Aldrich Research Biochemicals, 

Inc. to manufacture the basic classes of 

controlled substances is consistent with 

the public interest and with United 

States obligations under international 

treaties, conventions, or protocols in 

effect on May 1, 1971. The DEA 

investigated the company’s maintenance 

of effective controls against diversion by 

inspecting and testing the company’s 

physical security systems, verifying the 

company’s compliance with state and 

local laws, and reviewing the company’s 

background and history. 

Therefore, pursuant to 21 U.S.C. 

823(a), and in accordance with 21 CFR 

1301.33, the above named company is 

granted registration as a bulk 

manufacturer of the basic classes of 

controlled substances listed: 

Controlled substance Schedule 

Cathinone (1235) .......................... I 

Methcathinone (1237) .................. I 

Mephedrone (4-Methyl-Nmethylcathinone) (1248).I 

Aminorex (1585) ........................... I 

Alpha-ethyltryptamine (7249) ....... I 

Lysergic acid diethylamide (7315) I 

Tetrahydrocannabinols (7370) ..... I 

4-Bromo-2,5- 

dimethoxyamphetamine (7391).

I 

4-Bromo-2,5- 

dimethoxyphenethylamine 

(7392).

I 

4-Methyl-2,5- 

dimethoxyamphetamine (7395).

I 

2,5-Dimethoxyamphetamine 

(7396).

I 

3,4-Methylenedioxyamphetamine 

(7400).

I 

N-Hydroxy-3,4- 

methylenedioxyamphetamine 

(7402).

I 

3,4-Methylenedioxy-Nethylamphetamine (7404).I 

3,4- 

Methylenedioxymethamphetamine (MDMA) (7405).

I 

Dimethyltryptamine (7435) ........... I 

Psilocybin (7437) .......................... I 

5-Methoxy-N, Ndiisopropyltryptamine (7439).I 

1-[1-(2- 

Thienyl)cyclohexyl]piperidine 

(TCP) (7470).

I 

N-Benzylpiperazine (BZP) (7493) I 

MDPV (3,4- 

Methylenedioxypyrovalerone) 

(7535).

I 

Methylone (3,4-Methylenedioxy-Nmethylcathinone) (7540).I 

Heroin (9200) ............................... I 

Normorphine (9313) ..................... I 

Amphetamine (1100) .................... II 

Methamphetamine (1105) ............ II 

Nabilone (7379) ............................ II 

1-Phenylcyclohexylamine (7460) II 

Phencyclidine (7471) .................... II 

Cocaine (9041) ............................. II 

Codeine (9050) ............................. II 

Ecgonine (9180) ........................... II 

Levomethorphan (9210) ............... II 

Levorphanol (9220) ...................... II 

Meperidine (9230) ........................ II 

Metazocine (9240) ........................ II 

Methadone (9250) ........................ II 

Morphine (9300) ........................... II 

Thebaine (9333) ........................... II 

Levo-alphacetylmethadol (9648) .. II 

Remifentanil (9739) ...................... II 

Sufentanil (9740) .......................... II 

Carfentanil (9743) ......................... II 

Fentanyl (9801) ............................ II 

The company plans to manufacture 

reference standards. 

Dated: November 25, 2014. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2014–29119 Filed 12–10–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

Proposed Extension of Information 

Collection Request Submitted for 

Public Comment; Revisions to 

Coverage of Certain Preventive 

Services Under the Affordable Care 

Act 

AGENCY: Employee Benefits Security 

Administration, Department of Labor. 

ACTION: Notice. 

SUMMARY: The Department of Labor (the 

Department), in accordance with the 

Paperwork Reduction Act of 1995 (PRA 

95) (44 U.S.C. 3506(c)(2)(A)), provides 

the general public and Federal agencies 

with an opportunity to comment on 

proposed and continuing collections of 

information. This helps the Department 

assess the impact of its information 

collection requirements and minimize 

the reporting burden on the public and 

helps the public understand the 

Department’s information collection 

requirements and provide the requested 

data in the desired format. Currently, 

the Employee Benefits Security 

Administration is soliciting comments 

on the revision of the Coverage of 

Certain Preventive Services Under the 

Affordable Care Act information 

collection to reflect the new option of 

notifying the Department of Health and 

Human Services of the respondents’ 

objections to providing coverage in 

response to the Supreme Court of the 

United States’ interim order in 

connection with an application for an 

injunction in the pending case of 

Wheaton College v. Burwell. A copy of 

the information collection request (ICR) 

may be obtained by contacting the office 

listed in the ADDRESSES section of this 

notice. 

DATES: Written comments must be 

submitted to the office shown in the 

Addresses section on or before February 

9, 2015. 

ADDRESSES: Direct all written comments 

regarding the information collection 

request and burden estimates to G. 

Christopher Cosby, Office of Policy and 

Research, Employee Benefits Security 

Administration, U.S. Department of 

Labor, 200 Constitution Avenue NW., 

Room N–5718, Washington, DC 20210. 

Telephone: (202) 693–8410; Fax: (202) 

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73630 Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 

219–4745. These are not toll-free 

numbers. Comments may also be 

submitted electronically to the 

following Internet email address: 

ebsa.opr@dol.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Patient Protection and Affordable 

Care Act, Public Law 111–148, (the 

Affordable Care Act) was enacted by 

President Obama on March 23, 2010 and 

amended by the Health Care and 

Education Reconciliation Act of 2010, 

Public Law 111–152 on March 30, 2010. 

The Affordable Care Act added section 

2713 to the Public Health Service (PHS) 

Act and incorporated this provision into 

the Employee Retirement Income 

Security Act (ERISA) and the Internal 

Revenue Code (Code). The Departments 

of Health and Human Services, Labor, 

and Treasury (the Departments) 

published interim final rules (2010 

interim final rules) on July 19, 2010 to 

require non-grandfathered group health 

insurance coverage to provide benefits 

for certain preventive services without 

cost sharing, including benefits for 

certain women’s preventive health 

services as provided for in 

comprehensive guidelines supported by 

the Health Resources and Services 

Administration (HRSA). 

On August 1, 2011, HRSA adopted 

and released guidelines for women’s 

preventive health services, including 

contraceptive services. On August 3, 

2011, the Departments amended the 

2010 interim final rules (2011 amended 

interim final rules) to provide HRSA 

with the authority to exempt group 

health plans established or maintained 

by religious employers (and group 

health insurance coverage provided in 

connection with such plans) from the 

requirement to cover contraceptive 

services consistent with the HRSA 

guidelines. The 2011 amended interim 

final rules specified a definition of 

religious employer. HRSA exercised its 

authority in its guidelines to exempt 

plans established or maintained by 

religious employers (and group health 

insurance coverage provided in 

connection with such plans) from the 

requirement to cover contraceptive 

services. 

On February 6, 2013, the Departments 

published proposed rules that proposed 

to simplify and clarify the definition of 

religious employer and also proposed 

accommodations for health coverage 

established or maintained or arranged 

by certain nonprofit religious 

organizations with religious objections 

to contraceptive services (eligible 

organizations). The rules proposed that, 

for insured plans, the health insurance 

issuer providing group health insurance 

coverage in connection with the plan 

would be required to assume sole 

responsibility, independent of the 

eligible organization and its plan, for 

providing contraceptive coverage to 

plan participants and beneficiaries 

without cost sharing, premium, fee, or 

other charge to plan participants or 

beneficiaries or to the eligible 

organization or its plan. In the case of 

self-insured plans, the proposed 

regulations presented potential 

approaches under which the third party 

administrator of the plan would provide 

or arrange for a third party to provide 

separate contraceptive coverage to plan 

participants and beneficiaries without 

cost sharing, premium, fee, or other 

charge to plan participants or 

beneficiaries or to the eligible 

organization or its plan. The 

Departments received over 400,000 

comments (many of them standardized 

form letters) in response to the proposed 

regulations. 

After consideration of the comments, 

the Departments published final 

regulations on July 2, 2013. A 

contemporaneously-issued HHS 

guidance document extended the 

temporary safe harbor from enforcement 

of the contraceptive coverage 

requirement by the Departments to 

encompass plan years beginning on or 

after August 1, 2013, and before January 

1, 2014. This guidance included a form 

to be used by an organization during 

this temporary period to self-certify that 

its plan qualifies for the temporary 

enforcement safe harbor. In addition, 

HHS and the Department of Labor also 

issued a self-certification form, EBSA 

Form 700, to be executed by an 

organization seeking to be treated as an 

eligible organization for purposes of an 

accommodation under these final 

regulations. This self-certification form 

was provided for use with the 

accommodations under the July 2013 

final regulations, after the expiration of 

the temporary enforcement safe harbor 

(that is, for plan years beginning on or 

after January 1, 2014). The rules also 

provide that the third party 

administrator and issuer that is required 

to provide or arrange payments for 

contraceptive services must provide 

plan participants and beneficiaries with 

written notice of the availability of 

separate payments for contraceptive 

services contemporaneous with, but 

separate from, any application materials 

distributed in connection with 

enrollment for group health coverage for 

each plan year to which the 

accommodation is to apply. 

On July 3, 2014, the Supreme Court of 

the United States issued an interim 

order in connection with an application 

for an injunction in the pending case of 

Wheaton College v. Burwell, ruling that, 

‘‘[i]f [Wheaton College] informs the 

Secretary of Health and Human Services 

in writing that it is a non-profit 

organization that holds itself out as 

religious and has religious objections to 

providing coverage for contraceptive 

services, the [Departments of Labor, 

Health and Human Services, and the 

Treasury] are enjoined from enforcing 

against [Wheaton College]’’ certain 

provisions of the Affordable Care Act 

and related regulations requiring 

coverage without cost-sharing of certain 

contraceptive services ‘‘pending final 

disposition of appellate review’’ 

(Wheaton order). The order stated that 

Wheaton College need not use EBSA 

Form 700 or send a copy of the executed 

form to its health insurance issuers or 

third party administrators to meet the 

condition for this injunctive relief. The 

order also stated that it neither affected 

‘‘the ability of [Wheaton College’s] 

employees and students to obtain, 

without cost, the full range of FDA 

approved contraceptives,’’ nor 

precluded the Government from relying 

on the notice it receives from Wheaton 

College ‘‘to facilitate the provision of 

full contraceptive coverage under the 

Act.’’ 

On August 27, 2014, the Departments 

issued interim final regulations (79 FR 

66617) in light of the Supreme Court’s 

interim order concerning notification to 

the Federal government that an eligible 

organization has a religious objection to 

providing contraceptive coverage, as an 

alternative to the EBSA Form 700, and 

to preserve participants’ and 

beneficiaries’ access to coverage for the 

full range of FDA-approved 

contraceptives, as prescribed by a health 

care provider, without cost sharing, 

which is also consistent with the 

Supreme Court’s order. 

On August 27, 2014, the Office of 

Management and Budget (OMB) 

approved the changes as a revision to 

OMB Control Number 1210–0150 under 

the emergency procedures for review 

and clearance in accordance with the 

Paperwork Reduction Act of 1995 (P.L. 

104–13, 44 U.S.C. Chapter 35) and 5 

CFR 1320.13. OMB’s approval of the 

revision currently is schedule to expire 

on February 28, 2015. 

II. Current Actions 

This notice requests public comment 

pertaining to the Department’s request 

for extension of OMB’s approval of its 

revision to OMB Control Number 1210– 

0150 relating to the Coverage of Certain 

Preventive Services Under the 

Affordable Care Act. After considering 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 238 / Thursday, December 11, 2014 / Notices 73631 

comments received in response to this 

notice, the Department intends to 

submit an ICR to OMB for continuing 

approval. No change to the existing ICR 

is proposed or made at this time. The 

Department notes that an agency may 

not conduct or sponsor, and a person is 

not required to respond to, an 

information collection unless it displays 

a valid OMB control number. A 

summary of the ICR and the current 

burden estimates follows: 

Agency: Employee Benefits Security 

Administration, Department of Labor. 

Title: Coverage of Certain Preventive 

Services Under the Affordable Care Act. 

Type of Review: Revision of a 

currently approved collection of 

information. 

OMB Number: 1210–0150. 

Affected Public: Business or other forprofit; Not-for-profit institutions. 

Respondents: 61. 

Frequency of Responses: Once. 

Responses: 61. 

Estimated Total Burden Hours: 51. 

III. Desired Focus of Comments 

The Department of Labor 

(Department) is particularly interested 

in comments that: 

• Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

• Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

• Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

• Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., by permitting electronic 

submissions of responses. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the ICR for OMB approval 

of the extension of the information 

collection; they will also become a 

matter of public record. 

Dated: December 5, 2014. 

Phyllis C. Borzi, 

Assistant Secretary, Employee Benefits 

Security Administration. 

[FR Doc. 2014–29060 Filed 12–10–14; 8:45 am] 

BILLING CODE 4510–29–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

[Docket No. OSHA–2012–0035] 

Traylor/Skanska/Jay Dee Joint 

Venture; Application for Permanent 

Variance and Interim Order; Grant of 

Interim Order; Request for Comments 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Labor. 

ACTION: Notice. 

SUMMARY: In this notice, OSHA 

announces the application of Traylor/

Skanska/Jay Dee Joint Venture 

(collectively ‘‘Traylor JV’’ or ‘‘the 

applicant’’) for a permanent variance 

and interim order from the provisions of 

OSHA standards that regulate work in 

compressed air environments and 

presents the Agency’s preliminary 

finding to grant the permanent variance. 

OSHA invites the public to submit 

comments on the variance application 

to assist the Agency in determining 

whether to grant the applicant a 

permanent variance based on the 

conditions specified in this application. 

DATES: Submit comments, information, 

documents in response to this notice, 

and request for a hearing on or before 

January 12, 2015. The interim order 

described in this notice became effective 

on July 11, 2013, and shall remain in 

effect until the completion of the Blue 

Plains tunnel project or the interim 

order is modified or revoked. 

ADDRESSES: Submit comments by any of 

the following methods: 

1. Electronically: Submit comments 

and attachments electronically at http:// 

www.regulations.gov, which is the 

Federal eRulemaking Portal. Follow the 

instructions online for making 

electronic submissions. 

2. Facsimile: If submissions, 

including attachments, are not longer 

than 10 pages, commenters may fax 

them to the OSHA Docket Office at (202) 

693–1648. 

3. Regular or express mail, hand 

delivery, or messenger (courier) service: 

Submit comments, requests, and any 

attachments to the OSHA Docket Office, 

Docket No. OSHA–2012–0035, 

Technical Data Center, U.S. Department 

of Labor, 200 Constitution Avenue NW., 

Room N–2625, Washington, DC 20210; 

telephone: (202) 693–2350 (TTY 

number: (877) 889–5627). Note that 

security procedures may result in 

significant delays in receiving 

comments and other written materials 

by regular mail. Contact the OSHA 

Docket Office for information about 

security procedures concerning delivery 

of materials by express delivery, hand 

delivery, or messenger service. The 

hours of operation for the OSHA Docket 

Office are 8:15 a.m.–4:45 p.m., e.t. 

4. Instructions: All submissions must 

include the Agency name and the OSHA 

docket number (OSHA–2012–0035). 

OSHA places comments and other 

materials, including any personal 

information, in the public docket 

without revision, and these materials 

will be available online at http://

www.regulations.gov. Therefore, the 

Agency cautions commenters about 

submitting statements they do not want 

made available to the public, or 

submitting comments that contain 

personal information (either about 

themselves or others) such as Social 

Security numbers, birth dates, and 

medical data. 

5. Docket: To read or download 

submissions or other material in the 

docket, go to http://www.regulations.gov 

or the OSHA Docket Office at the 

address above. All documents in the 

docket are listed in the http://

www.regulations.gov index; however, 

some information (e.g., copyrighted 

material) is not publicly available to 

read or download through the Web site. 

All submissions, including copyrighted 

material, are available for inspection 

and copying at the OSHA Docket Office. 

Contact the OSHA Docket Office for 

assistance in locating docket 

submissions. 

6. Extension of comment period: 

Submit requests for an extension of the 

comment period on or before January 

12, 2015 to the Office of Technical 

Programs and Coordination Activities, 

Directorate of Technical Support and 

Emergency Management, Occupational 

Safety and Health Administration, U.S. 

Department of Labor, 200 Constitution 

Avenue NW., Room N–3655, 

Washington, DC 20210, or by fax to 

(202) 693–1644. 

FOR FURTHER INFORMATION CONTACT: 

Information regarding this notice is 

available from the following sources: 

Press inquiries: Contact Mr. Frank 

Meilinger, Director, OSHA Office of 

Communications, U.S. Department of 

Labor, 200 Constitution Avenue NW., 

Room N–3647, Washington, DC 20210; 

telephone: (202) 693–1999; email: 

Meilinger.francis2@dol.gov. 

General and technical information: 

Contact Mr. David W. Johnson, Director, 

Office of Technical Programs and 

Coordination Activities, Directorate of 

Technical Support and Emergency 

Management, Occupational Safety and 

Health Administration, U.S. Department 

of Labor, 200 Constitution Avenue NW., 

mstockstill on DSK4VPTVN1PROD with NOTICES