3466 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 

1 Identification Guidance for Homes with 

Corrosion from Problem Drywall as of March 18, 

2011, by the U.S. Consumer Product Safety 

Commission and the U.S. Department of Housing 

and Urban Development http://www.cpsc.gov//

PageFiles/115328/IDguidance031811.pdf. 

Remediation Guidance for Homes with Corrosion 

from Problem Drywall as of March 15, 2013, by the 

U.S. Consumer Product Safety Commission and the 

U.S. Department of Housing and Urban 

Development http://www.cpsc.gov//Global/

Safety%20Education/Safety-Information-Centers/

Drywall/remediation031513.pdf. 

46959 (August 11, 2014); Notice of November 

7, 2014, 79 FR 67035 (November 12, 2014). 

■ 6. Amend § 742.6 by revising 

paragraph (a)(4)(i) to read as follows: 

§ 742.6 Regional stability. 

(a) * * * 

(4) * * * 

(i) License requirements applicable to 

most RS Column 2 items. As indicated 

in the CCL and in RS Column 2 of the 

Commerce Country Chart (see 

Supplement No. 1 to part 738 of the 

EAR), a license is required to any 

destination except Australia, India, 

Japan, New Zealand, and countries in 

the North Atlantic Treaty Organization 

(NATO) for all items in ECCNs on the 

CCL that include RS Column 2 in the 

Country Chart column of the ‘‘License 

Requirements’’ section. A license 

continues to be required for items 

controlled under ECCNs 6A003.b.4.b 

and 9A515.e for RS Column 2 reasons 

when destined to India. 

* * * * * 

PART 758—[AMENDED] 

■ 7. The authority citation for part 758 

continues to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 

3 CFR, 2001 Comp., p. 783; Notice of August 

7, 2014, 79 FR 46959 (August 11, 2014). 

■ 8. Amend § 758.1 by adding paragraph 

(b)(9) to read as follows: 

§ 758.1 The Electronic Export Information 

(EEI) filing to the Automated Export System 

(AES). 

* * * * * 

(b) * * * 

(9) For items that fall under ECCNs 

that list CC Column 1 and 3 and RS 

Column 2 (see Supplement No. 1 to part 

738 of the EAR) as reasons for control 

and such items are for export, regardless 

of value, to India. 

* * * * * 

■ 9. Amend § 758.6 by adding paragraph 

(c) to read as follows: 

§ 758.6 Destination control statements and 

other information furnished to consignees. 

* * * * * 

(c) Additional requirement for items 

under ECCNs for which CC Column 1 or 

3 or RS Column 2 are listed as reasons 

for control and are destined to India. In 

addition to the DCS as required in 

paragraph (a) of this section, the 

following information must be printed 

on the invoice, bill of lading, air 

waybill, or other export control 

document that accompanies the 

shipment from its point of origin in the 

United States to the ultimate consignee 

or end-user in India: ‘‘These items are 

classified under Export Control 

Classification Number(s) (ECCN(s)) [Fillin the ECCNs for which CC 1 or 3 or RS 

2 are listed as reasons for control] and 

destined to India. Authorization for 

reexport from India may be required 

from the U.S. Department of 

Commerce.’’ 

Dated: January 20, 2015. 

Eric L. Hirschhorn, 

Under Secretary for Industry and Security. 

[FR Doc. 2015–01273 Filed 1–22–15; 8:45 am] 

BILLING CODE 3510–33–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Chapter II 

[Docket No. CPSC–2015–0002] 

Notice of Determination Under the 

Drywall Safety Act of 2012 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of determination. 

SUMMARY: The Consumer Product Safety 

Commission (CPSC, or Commission) is 

announcing that, pursuant to the 

requirements of the Drywall Safety Act 

of 2012 (DSA), the Commission has 

determined that: ASTM C1396–14a, 

‘‘Standard Specification for Gypsum 

Board,’’ is a voluntary standard for 

drywall manufactured or imported for 

use in the United States that limits 

sulfur content to a level not associated 

with elevated rates of corrosion in the 

home; ASTM C1396–14a became 

effective less than two years after the 

enactment of the DSA; and ASTM 

C1396–14a was developed by 

Subcommittee C11.01 on Specifications 

and Test Methods for Gypsum Products 

of ASTM International. Based on these 

determinations, the sulfur content limit 

in ASTM C1396–14a shall be treated as 

a consumer product safety rule 

promulgated under the Consumer 

Product Safety Act (CPSA). Drywall 

manufactured or imported for use in the 

United States shall be subject to the 

general conformity certification (GCC) 

requirements of the CPSA. 

DATES: This action becomes effective on 

July 22, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Rohit Khanna, Office of Hazard 

Identification and Reduction, U.S. 

Consumer Product Safety Commission, 

5 Research Place, Rockville, MD 20850; 

telephone (301) 987–2508; email 

rkhanna@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CPSC began investigating drywall in 

2009, after reports from homeowners 

that they were seeing corrosion of metal 

items inside their homes. According to 

homeowners’ reports, the items 

primarily involved were electrical 

fixtures, appliances, plumbing, and air 

conditioner coils. CPSC used the term 

‘‘problem drywall’’ to refer to drywall 

associated with elevated rates of metal 

corrosion. After CPSC’s initial 

investigations, CPSC joined with the 

U.S. Department of Housing and Urban 

Development (HUD), the U.S. Centers 

for Disease Control and Prevention 

(CDC), and the U.S. Environmental 

Protection Agency (EPA) to form the 

Federal Interagency Task Force on 

Problem Drywall (Task Force). 

In the course of this investigation, 

samples of problem drywall were 

analyzed for chemical content and 

emissions. CPSC staff analysis of 

chemical content and emissions from 

problem drywall determined that 

certain brands of drywall produced 

around the year 2006 contain elevated 

levels of elemental sulfur (octahedral 

sulfur, S8) and have elevated emission 

factors for hydrogen sulfide (H2S) and 

other reactive sulfur gases known to 

corrode materials containing copper and 

silver. CPSC staff’s analysis of the 

technical data also determined that the 

presence of elemental sulfur in excess of 

10 ppm in drywall is associated with 

elevated emission factors for hydrogen 

sulfide (H2S) and other reactive sulfur 

gases that are known to cause 

accelerated corrosion of copper and 

silver in homes. 

CPSC staff and HUD relied on the 

results of this analysis to develop 

guidance materials to help homeowners 

identify homes with problem drywall 

and to correct the problem by removing 

and replacing the problem drywall and 

certain other components of the home. 

These guidance documents are available 

on CPSC’s Web site.1

II. The Drywall Safety Act of 2012 

On January 14, 2013, the President 

signed the Drywall Safety Act of 2012 

(DSA) into law. Pub. L. 112–266, 126 

Stat. 2437 (2013). The DSA established 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 3467 

2Standard Specification for Sampling, Inspection, 

Rejection, Certification, Packaging, Marking, 

Shipping, Handling, and Storage of Gypsum Panel 

Products. 

3 Drywall Safety Act of 2012; Briefing 

Memorandum for Draft Federal Register Notice, 

Sulfur Content in Drywall Standard http://

www.cpsc.gov//Global/Newsroom/FOIA/

CommissionBriefingPackages/2015/Drywall-SafetyAct-FR-Notice-Sulfur-Content-in-DrywallStandard.pdf. 

several requirements related to problem 

drywall. 

The Drywall Labeling Requirement. 

The DSA states that 180 days after the 

date of enactment of the DSA, the 

gypsum board labeling provisions of 

standard ASTM C1264–11 2 must be 

treated as a rule promulgated by CPSC 

under section 14(c) of the CPSA. ASTM 

uses the more technical term ‘‘gypsum 

board’’ to refer to the class of products 

that CPSC refers to as ‘‘drywall.’’ The 

labeling provisions in ASTM C1264–11 

are currently in effect as a CPSC 

mandatory standard. The DSA provides 

a process for revision of the CPSC 

standard if ASTM revises the labeling 

provisions in the ASTM standard and 

notifies the Commission of the revision. 

To date, although ASTM has revised 

some provisions in ASTM C1264–11, 

ASTM has not revised the labeling 

provisions. 

Revision of Remediation Guidance for 

Drywall Disposal Required. The DSA 

requires the CPSC to revise CPSC’s 

guidance entitled ‘‘Remediation 

Guidance for Homes with Corrosion 

from Problem Drywall’’ to specify that 

problem drywall removed from homes 

pursuant to the guidance should not be 

reused or used as a component in the 

production of new drywall. CPSC 

revised the Remediation Guidance as 

directed when CPSC published a new 

Remediation Guidance on the CPSC 

Web site on March 15, 2013. 

Sulfur Content Standard 

Requirement. The DSA requires CPSC to 

promulgate a final rule pertaining to 

drywall manufactured or imported for 

use in the United States within two 

years of the date of enactment of the 

DSA. The rule must limit sulfur content 

‘‘to a level not associated with elevated 

rates of corrosion in the home.’’ As 

discussed below, the rulemaking 

requirement does not apply if the 

Commission makes certain 

determinations regarding an ASTM 

voluntary standard and publishes the 

determinations in the Federal Register. 

With this document, the Commission 

makes the necessary determinations. 

III. Standard for Sulfur Content in 

Drywall 

A. Determination 

Section 4(a) of the DSA requires the 

Commission to promulgate a final rule 

limiting sulfur content in drywall 

manufactured or imported for use in the 

United States ‘‘to a level not associated 

with elevated rates of corrosion in the 

home.’’ The rulemaking requirement 

does not apply if the Commission 

determines that: 

(a) A voluntary standard pertaining to 

drywall manufactured or imported for 

use in the United States limits sulfur 

content to a level not associated with 

elevated rates of corrosion in the home; 

(b) The voluntary standard is in effect 

within two years of enactment the DSA; 

and 

(c) The voluntary standard is 

developed by ASTM International’s 

Subcommittee C11.01 on Specifications 

and Test Methods for Gypsum Products. 

Id. 4(c). 

If the Commission makes such 

determinations, the sulfur content limit 

in the voluntary standard pertaining to 

drywall manufactured or imported for 

use in the United States ‘‘shall be 

treated as a consumer product safety 

rule under section 9 of the Consumer 

Product Safety Act.’’ 

Id. 4(d). 

The Commission determines that the 

sulfur limit stated in section 4.7 of 

ASTM C1396–14a, Standard 

Specification for Gypsum Board, meets 

the requirements of section 4(c) of the 

DSA. CPSC staff worked with the 

relevant ASTM Subcommittee (ASTM 

Subcommittee C11.01 on Specifications 

and Test Methods for Gypsum Products) 

to develop a test method for elemental 

sulfur in gypsum products. The test 

method is stated in ASTM Standard 

C471M, Test Methods for Chemical 

Analysis of Gypsum and Gypsum 

Products (Metric). ASTM Subcommittee 

C11.01 then worked with CPSC staff to 

develop a requirement stated in section 

4.7 of ASTM C1396–14a limiting the 

sulfur content of gypsum board. That 

provision requires that gypsum board 

must contain not greater than 10 ppm of 

orthorhombic cylooctasulfur (i.e., 

elemental sulfur or ‘‘S8’’) when tested in 

accordance with the test methods for 

Determination of S8 in Gypsum Panel 

Products by Liquid Extraction for 

Analysis by Liquid or Gas 

Chromatography in sections 55–65 of 

ASTM C471M. 

In accordance with section 4(c) of the 

DSA, ASTM C1396–14a is a voluntary 

standard pertaining to drywall 

manufactured or imported for use in the 

United States stating that gypsum board 

(drywall) ‘‘shall contain not greater than 

10 ppm of orthorhombic cyclooctasulfur 

(S8).’’ As discussed in the staff’s briefing 

memorandum,3 this limit on sulfur 

content is consistent with CPSC staff’s 

numerous corrosion studies, which 

showed an association between high 

levels of elemental sulfur (S8) in drywall 

and corrosion in the home, but no 

association between sulfur levels that 

did not exceed 10 ppm and elevated 

corrosion. 

ASTM C1396–14a was published and 

became effective October 14, 2014, less 

than two years after enactment of the 

DSA. Finally, ASTM C1396–14a was 

developed by Subcommittee C11.01 on 

Specifications and Test Methods for 

Gypsum Products of ASTM 

International. 

Based on these determinations the 

Commission finds that the requirements 

of section 4(c) of the DSA have been 

met. Accordingly, the sulfur content 

limit requirement stated in section 4.7 

of ASTM C1396–14a is a consumer 

product safety rule under the CPSA. 

B. Effective Date and Certification 

DSA section 4(d) provides that if the 

Commission determines that a voluntary 

standard meets the requirements of 

section 4(c) of the DSA, the sulfur 

content limit stated in the voluntary 

standard shall be treated as a consumer 

product safety rule beginning on the 

later of: 

• 180 days after publication of the 

Commission’s determination; or 

• the effective date stated in the 

voluntary standard. 

ASTM C1396–14a took effect when 

the standard was published on October 

14, 2014. Therefore, the sulfur content 

limit stated in ASTM C1396–14a shall 

be treated as a consumer product safety 

rule effective 180 days after publication 

of this determination in the Federal 

Register. 

Section 14(a)(1) of the CPSA requires 

that every manufacturer of a product 

that is subject to a consumer product 

safety rule and is imported into or 

distributed in the United States must 

certify that the product complies with 

all applicable CPSC rules, rules, bans, 

standards, or regulations. 15 U.S.C. 

2063(a)(1). As a product subject to a 

consumer product safety rule, drywall 

imported into or distributed in the 

United States will be subject to the 

certification requirements of section 

14(a)(1) of the CPSA (15 U.S.C. 

2063(a)(1)) and the Commission’s 

certification regulations at 16 CFR part 

1110 once the voluntary standard sulfur 

limit requirement is in effect as a 

consumer product safety standard. 

Drywall manufactured or imported on 

or after the effective date must comply 


emcdonald on DSK67QTVN1PROD with RULES
3468 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations 

1As discussed in a memorandum of 

understanding entered into by the Food and Drug 

Administration (FDA) and the National Institute on 

Drug Abuse (NIDA), the FDA acts as the lead agency 

within the HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 58 FR 35460, July 1, 1993. 

2http://www.accessdata.fda.gov/scripts/cder/

drugsatfda/

index.cfm?fuseaction=Search.DrugDetails (last 

accessed Sept. 26, 2014). 

with the sulfur content limits of ASTM 

C1396–14a and must be accompanied 

by a general certification of compliance 

(GCC). 

Alberta E. Mills, 

Acting Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2015–01051 Filed 1–22–15; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–400] 

Schedules of Controlled Substances: 

Removal of Naloxegol From Control 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Administrator of the Drug 

Enforcement Administration removes 

naloxegol ((5a,6a)-17-allyl-6-((20- 

hydroxy-3,6,9,12,15,18-hexaoxaicos-1- 

yl)oxy)-4,5-epoxymorphinon-3,14-diol) 

and its salts from the schedules of the 

Controlled Substances Act (CSA). This 

scheduling action is pursuant to the 

CSA which requires that such actions be 

made on the record after opportunity for 

a hearing through formal rulemaking. 

Prior to the effective date of this rule, 

naloxegol was a schedule II controlled 

substance because it can be derived 

from opium alkaloids. This action 

removes the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to controlled 

substances, including those specific to 

schedule II controlled substances, on 

persons who handle (manufacture, 

distribute, reverse distribute, dispense, 

conduct research, import, export, or 

conduct chemical analysis) or propose 

to handle naloxegol. 

DATES: Effective Date: January 23, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Drug Enforcement 

Administration (DEA) implements and 

enforces titles II and III of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970, as amended. 21 

U.S.C. 801–971. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, but they are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purposes of this action. The DEA 

publishes the implementing regulations 

for these statutes in title 21 of the Code 

of Federal Regulations (CFR), parts 1300 

to 1321. The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

providing for the legitimate medical, 

scientific, research, and industrial needs 

of the United States. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. 

Under the CSA, each controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, its currently accepted medical 

use in treatment in the United States, 

and the degree of dependence the drug 

or other substance may cause. 21 U.S.C. 

812. The initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c) and the 

current list of scheduled substances is 

published at 21 CFR 1308. 21 U.S.C. 

812(a). 

Pursuant to 21 U.S.C. 811(a)(2), the 

Attorney General may, by rule, ‘‘remove 

any drug or other substance from the 

schedules if he finds that the drug or 

other substance does not meet the 

requirements for inclusion in any 

schedule.’’ The Attorney General has 

delegated scheduling authority under 21 

U.S.C. 811 to the Administrator of the 

DEA. 28 CFR 0.100. 

The CSA provides that proceedings 

for the issuance, amendment, or repeal 

of the scheduling of any drug or other 

substance may be initiated by the 

Attorney General (1) on his own motion, 

(2) at the request of the Secretary of the 

Department of Health and Human 

Services (HHS),1 or (3) on the petition 

of any interested party. 21 U.S.C. 811(a). 

This action was initiated by a petition 

from the drug sponsor to remove 

naloxegol from the list of scheduled 

controlled substances of the CSA, and is 

supported by, inter alia, a 

recommendation from the Assistant 

Secretary of the HHS and an evaluation 

of all relevant data by the DEA. This 

action removes the regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to controlled 

substances, including those specific to 

schedule II controlled substances, on 

persons who handle or propose to 

handle naloxegol. 

Background 

Naloxegol, or PEG-naloxol, is a new 

molecular entity and is a polyethylene 

glycolyated (PEGylated) derivative of 

naloxone. Its chemical names are 

(5a,6a)-17-allyl-6-((20-hydroxy3,6,9,12,15,18-hexaoxaicos-1-yl)oxy)- 

4,5-epoxymorphinon-3,14-diol or alpha6mPEG7-O-naloxol. Naloxegol is an 

antagonist predominantly of peripheral 

mu opioid receptors. The Food and 

Drug Administration (FDA) approved 

naloxegol for marketing on September 

16, 2014, under the brand name 

MovantikTM.2 It is indicated for the 

treatment of opioid-induced 

constipation (OIC) in adults with 

chronic non-cancer pain. 

Gastrointestinal adverse events (AEs) 

effects are commonly experienced by 

chronic users of opioid analgesics. 

Opioids delay gastric emptying and 

intestinal transport, which over time 

leads to debilitating constipation. OIC is 

caused by activation of the mu opioid 

receptor in the GI tract. 

DEA and HHS Eight Factor Analyses 

The DEA received a petition from the 

drug sponsor dated March 22, 2012, 

requesting that the DEA amend 21 CFR 

1308.12(b)(1) to exclude naloxegol as a 

schedule II controlled substance. The 

petitioner stated that naloxegol is a mu 

opioid receptor antagonist without mu 

opioid agonist or partial agonist 

properties. The DEA accepted the 

petition for filing on October 1, 2012. 

On February 7, 2013 the DEA 

forwarded to the HHS the data with the 

sponsor’s petition along with a request 

for a scientific and medical evaluation 

and the HHS’s recommendation as to 

whether or not naloxegol should be 

removed from the list of controlled 

substances. According to the HHS, the 

sponsor submitted a New Drug 

Application (NDA) for naloxegol on 

September 16, 2013. Based on the NDA, 

the HHS summarized that naloxegol is 

an antagonist of peripheral opioid 

receptors for the treatment of OIC. 

On August 8, 2014, the HHS provided 

to the DEA a scientific and medical 

evaluation document prepared by the 

FDA entitled ‘‘Basis for the 


emcdonald on DSK67QTVN1PROD with RULES