Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 15635 

1 7 U.S.C. 12(a). 

2Section 1a(29) of the Act defines the term 

registered entity to mean: ‘‘(A) a board of trade 

designated as a contract market under section 5; (B) 

a derivatives transaction execution facility 

registered under section 5a; (C) a derivatives 

clearing organization registered under section 5b; 

(D) a board of trade designated as a contract market 

under section 5f; and (E) with respect to a contract 

that the Commission determines is a significant 

price discovery contract, any electronic trading 

facility on which the contract is executed or 

traded.’’ 

3 In addition to ‘‘registered entities,’’ the 

Commission is authorized to share confidential 

information with registered futures associations (see 

section 17 of the Act, 7 U.S.C. 21) and selfregulatory organizations as defined in section 

3(a)(26) of the Securities Exchange Act of 1934. 7 

U.S.C. 12a(6). 

4Public Law 106–554, 114 Stat. 2763 (2000). 

5 Incorporated as Title XIII of the Food, 

Conservation and Energy Act of 2008, Public Law 

110–246, 122 Stat. 1624 (June 18, 2008). 

N., long. 94°09′52′′ W.; to the point of 

beginning. 

Designated altitudes. 13,000 feet MSL to, 

but not including, FL 220. 

Time of designation. Sunrise to sunset, 

daily; other times by NOTAM. 

Controlling agency. FAA, Memphis 

ARTCC. 

Using agency. Arkansas Air National 

Guard, 188th Fighter Wing, Ft. Smith, AR. 

Issued in Washington, DC, on March 19, 

2010. 

Edith V. Parish, 

Manager, Airspace and Rules Group. 

[FR Doc. 2010–7075 Filed 3–29–10; 8:45 am] 

BILLING CODE 4910–13–P 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Parts 38 and 140 

RIN 3038—AC68 

Delegations of Authority To Disclose 

Confidential Information 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Commodity Futures 

Trading Commission (‘‘CFTC’’ or 

‘‘Commission’’) is proposing to amend 

its regulations governing delegations of 

authority to disclose confidential 

information to permit CFTC staff to 

provide confidential information to 

‘‘registered entities,’’ including exempt 

commercial markets offering significant 

price discovery contracts, and to require 

that registered entities update their lists 

of confidential data recipients on an 

annual basis. The Commission’s 

proposal would also clarify that 

confidential information provided by 

the Commission to registered entities 

may only be used for market 

surveillance, audit, investigative or rule 

enforcement purposes and would 

remove the requirement that disclosures 

of confidential information to foreign 

government agencies and foreign futures 

authorities require the concurrence of 

the Commission’s Division of 

Enforcement. Finally, the proposal 

would make certain other technical and 

conforming amendments to the 

Commission’s rules. 

DATES: Comments must be received by 

April 29, 2010. 

ADDRESSES: Comments should be 

submitted to David Stawick, Secretary, 

Commodity Futures Trading 

Commission, Three Lafayette Centre, 

1155 21st Street, NW., Washington, DC 

20581. Comments also may be sent by 

facsimile to (202) 418–5521, or by email to confidentialinforules@cftc.gov. 

Reference should be made to 

‘‘Delegations of Authority to Disclose 

Confidential Information.’’ Comments 

may also be submitted through the 

Federal eRulemaking Portal at http:// 

www.regulations.gov. All comments 

must be in English. 

FOR FURTHER INFORMATION CONTACT: 

Donald Heitman, Senior Special 

Counsel, Division of Market Oversight, 

Commodity Futures Trading 

Commission, Three Lafayette Centre, 

1155 21st Street, NW., Washington, DC 

20581. Telephone: (202) 418–5041. Email: dheitman@cftc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Commodity Exchange Act’s 

Confidentiality Provisions 

Section 8(a) of the Commodity 

Exchange Act (‘‘CEA’’ or ‘‘Act’’) prohibits 

the Commission from disclosing 

information that would separately 

disclose the business transactions or 

market positions of any person or trade 

secrets or names of customers.1 Despite 

this general prohibition, the CEA 

recognizes the need to share 

confidential information with registered 

entities and certain other self-regulatory 

bodies under specified circumstances. 

Section 8a(6) of the Act therefore 

authorizes the Commission to 

communicate to the proper officials of 

‘‘registered entities’’ 2 and other selfregulatory bodies 3 the full facts 

regarding a particular transaction or 

market operation, ‘‘which in the 

judgment of the Commission disrupts or 

tends to disrupt any market or is 

otherwise harmful or against the best 

interests of producers, consumers, or 

investors, or which is necessary or 

appropriate to effectuate the purposes of 

[the] Act.’’ Disclosure under this 

provision is subject to the caveat that 

information furnished by the 

Commission may not be disclosed by 

the receiving registered entity, 

registered futures association or selfregulatory organization except in a selfregulatory action or proceeding. 

Commission regulation 140.72 

implements these statutory provisions, 

delegates to specified senior staff the 

authority to make disclosures to ‘‘a 

contract market, registered futures 

association or self-regulatory 

organization,’’ and establishes the 

standards and protocols governing such 

disclosures. However, regulation 140.72 

has never been amended to replace the 

reference to ‘‘contract market’’ with a 

reference to the more inclusive defined 

term, ‘‘registered entity,’’ which includes 

not only designated contract markets, 

but several other types of entities as 

well (see note 2 above). The term, 

‘‘registered entity,’’ was added to the Act 

by the Commodity Futures 

Modernization Act of 2000 (‘‘CFMA’’).4

The registered entity definition was 

subsequently expanded by the CFTC 

Reauthorization Act of 2008 (‘‘2008 

Reauthorization Act’’),5 which 

incorporated electronic trading facilities 

trading significant price discovery 

contracts into the registered entity 

definition as section 1a(29)(E). 

The CEA also recognizes the need to 

share confidential information with 

other Federal or state regulatory 

authorities, acting within the scope of 

their jurisdiction, as well as foreign 

futures authorities, and in section 8(e) 

authorizes the Commission to make 

such disclosures on request, provided 

the Commission is satisfied that the 

information will not be disclosed except 

in connection with an action or 

proceeding brought under the laws 

governing the receiving authority, to 

which that receiving authority is a 

party. Commission regulation 140.73 

implements the provisions of CEA 

section 8(e), delegates to specified 

senior staff the authority to make 

disclosures and establishes the 

standards and protocols governing 

disclosure to a requesting regulator. 

As discussed below, the principal 

amendments to regulation 140.72 are 

being proposed: (1) To conform the 

Commission’s rule to the CEA, as 

amended by the CFMA and the 2008 

Reauthorization Act, by applying the 

regulation to ‘‘registered entities;’’ (2) to 

require that registered entities update 

their lists of confidential data recipients 

on an annual basis and notify the 

Commission within 10 business days of 

any changes to the list; and (3) to clarify 

that confidential information provided 

by the Commission to registered entities 

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15636 Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 

6The amendments proposed herein would not 

alter those requirements since the amendments 

would replace the term, ‘‘contract market,’’ with the 

term, ‘‘registered entity,’’ which by definition 

includes contract markets. 7As noted above, the 2008 Reauthorization Act 

added the following provision to section 1(a)(29)’s 

definition of registered entity: ‘‘(E) with respect to 

a contract that the Commission determines is a 

significant price discovery contract, any electronic 

trading facility on which the contract is executed 

or traded.’’ 7 U.S.C. 1(a)(29)(E). 

8For example, Part 17 of the Commission’s 

regulations requires that clearing members, FCMs, 

and foreign brokers file daily large trader reports 

with the Commission. The Kansas City Board of 

Trade (KCBT) and the Minneapolis Grain Exchange 

(MGX) rely on receiving daily transmissions of large 

trader reports from the Commission for monitoring 

speculative position limits and reportable positions. 

The remaining DCMs have adopted their own large 

trader reporting rules and independently collect 

large trader reports. Under this proposed rule, 

KCBT and MGX would be prohibited from using the 

confidential large trader reports they receive from 

the Commission for anything other than market 

surveillance, audit, investigative or rule 

enforcement purposes. DCMs that independently 

collect large trader reports would not be subject to 

the same prohibitions because they do not receive 

the data from the Commission. 

may only be used for market 

surveillance, audit, investigative or rule 

enforcement responsibilities of the 

registered entity. The Commission 

additionally is proposing technical 

amendments to both regulations 140.72 

and 140.73. 

B. Part 38 of the Commission’s 

Regulations 

As noted above, by its terms, 

regulation 140.72 includes procedural 

requirements for DCMs that relate to the 

receipt and use of information furnished 

by the CFTC.6 As a result of the passage 

of the CFMA, the Commission adopted 

regulations that exempted DCMs from 

all Commission regulations that were 

not specifically reserved in regulation 

38.2. Regulation 140.72 was not 

specifically reserved in regulation 38.2. 

The Commission, however, believes that 

regulation 140.72 (both in its current 

form and as proposed to be amended 

herein) contains procedural safeguards 

that are intended to protect furnished 

information from improper use and 

disclosure. In that regard, the 

Commission attaches particular 

importance to the requirement that 

registered entities (including DCMs) 

must formally identify the officials 

within the organization who are 

specifically authorized to receive 

information from Commission staff and 

update that contact information 

annually. The Commission therefore 

proposes to add regulation 140.72 to the 

list of regulations reserved in regulation 

38.2. 

II. Discussion 

A. Amendments Necessitated by the 

CFMA and the CFTC Reauthorization 

Act of 2008 

The 2008 Reauthorization Act directs 

the CFTC to extend its regulatory 

oversight to the trading of significant 

price discovery contracts (‘‘SPDCs’’) on 

exempt commercial markets (‘‘ECMs’’) 

and, among other statutory 

amendments, adds ECMs with SPDCs to 

the definition of ‘‘registered entity’’ in 

section 1(a)(29) of the CEA.7

Accordingly, with respect to a contract 

that the Commission determines is a 

SPDC, the ECM on which it is traded or 

executed becomes a registered entity 

subject to all the provisions of the CEA 

applicable to registered entities— 

including section 8a(6) of the Act. 

Consistent with this statutory change, 

the proposed amendments to regulation 

140.72 would make its provisions 

applicable to ‘‘registered entities’’ and 

would permit staff to disclose 

confidential information to ECMs 

insofar as the disclosures relate to the 

ECM’s SPDCs. 

Regulation 140.72(b) provides that 

disclosures shall only be made to a 

contract market, registered futures 

association or self-regulatory 

organization official who is named in a 

list filed with the Commission by the 

chief executive officer of the entity. By 

amending paragraph (b) to refer to 

‘‘registered entities’’ (instead of ‘‘contract 

markets’’) the proposed amendments 

would apply the disclosure rules to all 

such registered entities, including, 

among others, derivatives clearing 

organizations (‘‘DCOs’’) and ECMs with 

respect to their SPDCs. Thus, for 

example, all registered entities would be 

required to provide to the Commission 

a list of officials within their 

organization authorized to receive 

disclosures of confidential information. 

The proposed rules would also require 

that the lists of officials authorized to 

receive disclosures must be updated 

annually. Finally, the proposed 

amendments would clarify that the chief 

executive officer of the registered entity 

must notify the Commission within ten 

business days of any additions or 

deletions to the list. 

B. Amendments Regarding the Use of 

Confidential Information 

Recently, questions have arisen 

regarding the potential use of 

confidential information provided by 

the Commission to DCMs. In particular, 

DCM officials have inquired as to 

whether they might be allowed to use 

that information to assess the current 

composition of a given market with an 

eye to developing additional types of 

contracts. Consistent with the Section 

8a(6), these proposed rules clarify that 

confidential information provided by 

the Commission to registered entities 

(including DCMs) can only be used for 

their market surveillance, audit, 

investigative or rule enforcement 

responsibilities, which do not include 

business development purposes. The 

Commission solicits comments 

regarding whether similar restrictions 

should be applied to confidential 

information generated internally by a 

registered entity.8 In addition, registered 

entities should review their procedures 

for the handling of confidential 

information from the Commission to 

ensure that persons handling such 

information are properly ‘‘walled off’’ 

from the rest of the organization. 

C. Technical and Conforming 

Amendments 

Regulations 140.72(a) and 140.73(a) 

currently list, by title, a large number of 

senior staff members to whom the 

Commission delegates authority to 

disclose confidential information to the 

various regulatory and self-regulatory 

authorities listed in those respective 

regulations. Many of these titles have 

been rendered obsolete by subsequent 

CFTC organizational changes. In order 

to simplify the regulations and 

minimize the need for further regulatory 

amendments to conform to future 

organizational changes, the proposed 

regulations would delegate the authority 

to disclose confidential information to 

the heads of the major Commission 

Divisions or Offices involved and give 

those individuals the authority to subdelegate that authority to such other 

employees of their respective Divisions 

or Offices as they may designate from 

time to time. 

As noted above, regulation 140.73 

delegates to specified senior staff the 

authority to disclose confidential 

information to United States, state and 

foreign government agencies and to 

foreign futures authorities. Regulation 

140.73(b) currently requires that 

disclosures made pursuant to this 

section must be made with the 

concurrence of the Director of the 

Division of Enforcement or his or her 

designee. For efficiency, the 

Commission proposes to delete 

paragraph (b) of regulation 140.73. 

The CFMA added a number of new 

definitions to section 1a of the CEA. As 

a result, the definition of ‘‘foreign 

futures authority,’’ formerly found in 

section 1a(10) of the CEA, has been 

renumbered as section 1(a)(18). The 

Commission proposes a conforming 

amendment to regulation 140.73(a)(3), 

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Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 15637 

9See: 47 FR 18618 at 18619 (April 30, 1982) with 

respect to DCMs; 66 FR 42255 at 42268 (August 10, 

2001) with respect to DTEFs and ECMs; and 66 FR 

45604 at 45609 (August 29, 2001) with respect to 

DCOs. 

10Section 5f deals with ‘‘Designation of Securities 

Exchanges and Associations as Contract Markets.’’ 

which is applicable to foreign futures 

authorities, to correctly identify the 

definitional section. 

III. Related Matters 

A. Cost Benefit Analysis 

Section 15(a) of the CEA requires the 

Commission to consider the costs and 

benefits of its actions before issuing new 

regulations under the Act. Section 15(a) 

does not require the Commission to 

quantify the costs and benefits of new 

regulations or to determine whether the 

benefits of adopted regulations 

outweigh their costs. Rather, section 

15(a) requires the Commission to 

consider the costs and benefits of the 

subject regulations in light of five broad 

areas of market and public concern: (1) 

Protection of market participants and 

the public; (2) efficiency, 

competitiveness, and financial integrity 

of the market for listed derivatives; (3) 

price discovery; (4) sound risk 

management practices; and (5) other 

public interest considerations. The 

Commission may, in its discretion, give 

greater weight to any one of the five 

enumerated areas of concern and may, 

in its discretion, determine that, not 

withstanding its costs, a particular 

regulation is necessary or appropriate to 

protect the public interest. 

As relevant here, the proposed 

amendments would extend the 

information-sharing provisions of 

regulation 140.72 to registered entities, 

including DCOs and exempt commercial 

markets with respect to their SPDCs, 

among others. The authority and 

benefits of the provisions regarding 

disclosure of confidential information 

derive from a determination that the 

transaction or market operation to be 

disclosed disrupts or tends to disrupt 

any market; or is otherwise harmful or 

against the best interests of producers, 

consumers, or investors; or that 

disclosure is necessary or appropriate to 

effectuate the purposes of the CEA. The 

other proposed amendments would 

clarify, consistent with the language of 

Section 8a(6) and regulation 140.72(d), 

that registered entities could only use 

the information for their market 

surveillance, audit, investigative or rule 

enforcement responsibilities and would 

enhance the reliability of the disclosure 

system by requiring registered entities to 

update their lists of confidential data 

recipients on an annual basis and to 

notify the Commission of any changes to 

such lists in a timely fashion. The costs 

associated with these proposed 

amendments are minimal. Extending the 

regulations’ confidential disclosure 

requirements to registered entities, 

including ECMs with SPDCs, while 

clarifying the confidentiality protections 

and improving the reliability of the 

disclosure system, enhances the 

Commission’s ability to prevent market 

disruptions and protect the interests of 

producers, consumers and the public. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

(‘‘RFA’’), 5 U.S.C. 601 et seq., requires 

that agencies, in proposing rules, 

consider the impact of those rules on 

small entities. These amendments 

would extend CFTC staff’s ability to 

share relevant information with 

additional registered entities, including 

ECMs with SPDCs, would further 

protect the confidentiality of disclosed 

information by requiring that registered 

entities could only use the information 

for their market surveillance, audit, 

investigative or rule enforcement 

responsibilities and would enhance the 

reliability of the disclosure system by 

requiring registered entities to update 

their lists of confidential data recipients 

on an annual basis. The proposed rules 

otherwise would make technical and 

conforming changes to rules 140.72 and 

140.73. The Commission has previously 

determined that DCMs, derivatives 

transaction execution facilities 

(‘‘DTEFs’’), ECMs (with or without 

SPDCs) and DCOs are not small entities 

for purposes of the RFA.9 Similarly, the 

Commission believes that the other type 

of registered entity listed in section 

1a(29) of the Act, a board of trade 

designated as a contract market under 

section 5f,10 is likewise not a small 

entity for purposes of the RFA. 

Accordingly, the Commission does not 

expect that these amendments will have 

a significant impact on a substantial 

number of small entities. For this 

reason, and pursuant to section 3(a) of 

the RFA, 5 U.S.C. 605(b), the Chairman, 

on behalf of the Commission, hereby 

certifies that these regulations will not 

have a significant economic impact on 

a substantial number of small entities. 

Nevertheless, the Commission solicits 

public comments as to whether a DTEF, 

a DCM designated under section 5f of 

the Act or an ECM with a SPDC should 

be considered a small entity for 

purposes of the RFA. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act of 1980 

(‘‘PRA’’), 44 U.S.C. 3501 et seq., imposes 

certain requirements on Federal 

agencies, including the Commission, in 

connection with conducting or 

sponsoring any collection of 

information as defined by the PRA. 

Rules 140.72 and 140.73 are not 

associated with an information 

collection as defined by the PRA. 

Accordingly, the Commission certifies 

that, for purposes of the PRA, these 

proposed amendments would not 

impose any new reporting or 

recordkeeping requirements. 

List of Subjects 

17 CFR Part 38 

Block transactions, Commodity 

futures, Contract markets, Transactions 

off the centralized market, Reporting 

and recordkeeping requirements. 

17 CFR Part 140 

Authority delegations (Government 

agencies), Organization and functions 

(Government agencies). 

Accordingly, the Commission 

proposes to amend 17 CFR parts 38 and 

140 as follows: 

PART 38—DESIGNATED CONTRACT 

MARKETS 

1. The authority citation for part 38 is 

revised to read as follows: 

Authority: 7 U.S.C. 2, 5, 6, 6c, 7, and 12a, 

as amended by the Commodity Futures 

Modernization Act of 2000, Appendix E of 

Pub. L. 106–554, 114 Stat. 2763 (2000). 

2. Section 38.2 is revised to read as 

follows: 

§ 38.2 Exemption. 

Agreements, contracts, or transactions 

traded on a designated contract market 

under Section 5 of the Act, the contract 

market and the contract market’s 

operator are exempt from all 

Commission regulations for such 

activity, except for the requirements of 

this Part 38 and §§ 1.3, 1.12(e), 1.31, 

1.37(c)–(d), 1.38, 1.52, 1.59(d), 1.60, 

1.63(c), 1.67, 33.10, Part 9, Parts 15 

through 21, Part 40, Part 41, § 140.72 

and Part 190 of this chapter, including 

any related definitions and crossreferenced sections. 

PART 140—ORGANIZATION, 

FUNCTIONS AND PROCEDURES OF 

THE COMMISSION 

3. The authority citation for part 140 

conitnues to read as follows: 

Authority: 7 U.S.C. 2 and 12a. 

4. Section 140.72 is revised to read as 

follows: 

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15638 Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 

§ 140.72 Delegation of authority to 

disclose confidential information to a 

registered entity, registered futures 

association or self-regulatory organization. 

(a) Pursuant to the authority granted 

under sections 2(a)(12), 8a(5) and 8a(6) 

of the Act, the Commission hereby 

delegates, until such time as the 

Commission orders otherwise, to the 

Director of the Division of Market 

Oversight, the Director of the Division of 

Clearing and Intermediary Oversight, 

the Director of the Division of 

Enforcement, the General Counsel, the 

Chief Economist and the Director of the 

Office of International Affairs, and to 

such other employees of their respective 

Divisions and Offices as they may 

designate from time to time, the 

authority to disclose to an official of any 

registered entity (as defined in section 

1a(29) of the Act), registered futures 

association, or self-regulatory 

organization as defined in section 

3(a)(26) of the Securities Exchange Act 

of 1934, any information necessary or 

appropriate to effectuate the purposes of 

the Act, including, but not limited to, 

the full facts concerning any transaction 

or market operation, including the 

names of the parties thereto. This 

authority to disclose shall be based on 

a determination that the transaction or 

market operation disrupts or tends to 

disrupt any market or is otherwise 

harmful or against the best interests of 

producers, consumers, or investors or 

that disclosure is necessary or 

appropriate to effectuate the purposes of 

the Act. The authority to make such a 

determination is also delegated by the 

Commission to the Commission 

employees identified in this section. A 

Commission employee delegated 

authority under this section may 

exercise that authority on his or her own 

initiative or in response to a request by 

an official of a registered entity, 

registered futures association or selfregulatory organization. 

(b) Disclosure under this section shall 

only be made to a registered entity, 

registered futures association or selfregulatory organization official who is 

named in a list filed with the 

Commission by the chief executive 

officer of the registered entity, registered 

futures association or self-regulatory 

organization, which sets forth the 

official’s name, business address and 

telephone number. The chief executive 

officer shall provide the Commission 

with an updated list annually, during 

the first month of the calendar year, and 

shall thereafter notify the Commission 

within 10 business days of any deletions 

or additions to the list of officials 

authorized to receive disclosures under 

this section. The original list, each 

annual update, and any supplemental 

list required by his paragraph shall be 

filed with the Secretary of the 

Commission, and a copy thereof shall 

also be filed with the Regional 

Administrator for the region in which 

the registered entity is located or in 

which the registered futures association 

or self-regulatory organization has its 

principal office. 

(c) Notwithstanding the provisions of 

paragraph (a) of this section, in any case 

in which a Commission employee 

delegated authority under this section 

believes it appropriate, he or she may 

submit to the Commission for its 

consideration the question of whether 

disclosure of information should be 

made. Nothing in this section shall 

prevent the Commission from exercising 

the authority delegated in paragraph (a) 

of this section. 

(d) For purposes of this section, the 

term ‘‘official’’ shall mean any officer or 

member of the staff, management or a 

committee of a registered entity, 

registered futures association or selfregulatory organization who is 

specifically charged with market 

surveillance, audit, investigative or rule 

enforcement responsibilities, or their 

duly authorized representative or agent, 

who is named on the list filed pursuant 

to paragraph (b) of this section or any 

supplement thereto. 

(e) For the purposes of this section, 

the term ‘‘self-regulatory organization’’ 

shall mean the same as that defined in 

section 3(a)(26) of the Securities 

Exchange Act of 1934. 

(f) Any registered entity, registered 

futures association or self-regulatory 

organization receiving information from 

the Commission under these provisions 

may use such information only for its 

market surveillance, audit, investigative 

or rule enforcement responsibilities and 

shall not disclose such information, 

except that disclosure may be made in 

any self-regulatory action or proceeding. 

5. Section 140.73 is revised to read as 

follows: 

§ 140.73 Delegation of authority to 

disclose information to United States, State, 

and foreign government agencies and 

foreign futures authorities. 

(a) Pursuant to sections 2(a)(12), 8a(5) 

and 8(e) of the Act, the Commission 

hereby delegates, until such time as the 

Commission orders otherwise, to the 

General Counsel, the Director of the 

Division of Enforcement, the Director of 

the Division of Market Oversight, the 

Director of the Division of Clearing and 

Intermediary Oversight, the Chief 

Economist and the Director of the Office 

of International Affairs, and to such 

other employees of their respective 

Divisions and Offices as they may 

designate from time to time, the 

authority to furnish information in the 

possession of the Commission obtained 

in connection with the administration of 

the Act, upon written request, to: 

(1) Any department or agency of the 

United States, including for this 

purpose an independent regulatory 

agency, acting within the scope of its 

jurisdiction; 

(2) Any department or agency of any 

State or any political subdivision 

thereof, acting within the scope of its 

jurisdiction; or 

(3) Any foreign futures authority, as 

that term is defined in section 1a(18) of 

the Act, or any department or agency of 

any foreign government or political 

subdivision thereof, acting within the 

scope of its jurisdiction, provided that 

the Commission official making the 

disclosure is satisfied that the 

information will not be disclosed except 

in connection with an adjudicatory 

action or proceeding brought under the 

laws of such foreign government or 

political subdivision to which such 

foreign government or political 

subdivision or any department or 

agency thereof, or foreign futures 

authority is a party. 

(b) In furnishing information under 

this delegation pursuant to paragraphs 

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

Commission official making the 

disclosure shall remind the department 

or agency involved that section 8(e) of 

the Act prohibits the disclosure by such 

department or agency of information 

that would separately disclose the 

business transactions or market 

positions of any person and trade 

secrets or names of customers except in 

an action or proceeding under the laws 

of the United States, the State, or a 

political subdivision thereof to which 

the department or the agency of either 

the state or political subdivision, the 

Commission, or the United States is a 

party. 

(c) This delegation shall not affect any 

other delegation that the Commission 

has made or may make, which 

authorizes any other officer or employee 

of the Commission to furnish 

information to governmental bodies on 

the Commission’s behalf. 

(d) Notwithstanding the provisions of 

paragraph (a) of this section, in any case 

in which any employee delegated 

authority therein believes it appropriate, 

the matter may be submitted to the 

Commission for its consideration. 

Nothing in this section shall prohibit 

the Commission from exercising the 

authority delegated in paragraph (a) of 

this section. 

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Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules 15639 

Issued in Washington, DC, on March 22, 

2010, by the Commission. 

David A. Stawick, 

Secretary of the Commission. 

[FR Doc. 2010–6813 Filed 3–29–10; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 610 

[Docket No. FDA–2010–N–0099] 

RIN 0910–AG15 

Revision of the Requirements for 

Constituent Materials 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the biologics regulations to 

permit the Director of the Center for 

Biologics Evaluation and Research 

(CBER) or the Director of the Center for 

Drug Evaluation and Research (CDER), 

as appropriate, to approve exceptions or 

alternatives to the regulation for 

constituent materials. FDA is taking this 

action due to advances in developing 

and manufacturing safe, pure, and 

potent biological products licensed 

under a section of the Public Health 

Service Act (the PHS Act) that, in some 

instances, render the existing 

constituent materials regulation too 

prescriptive and unnecessarily 

restrictive. This rule provides 

manufacturers of licensed biological 

products with flexibility, as appropriate, 

to employ advances in science and 

technology as they become available, 

without diminishing public health 

protections. 

DATES: Submit electronic or written 

comments on the proposed rule on or 

before June 28, 2010. Submit comments 

on information collection issues under 

the Paperwork Reduction Act of 1995 by 

April 29, 2010, (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0099 and/or RIN number 0910–AG15, 

by any of the following methods, except 

that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the agency name and 

Docket No. and Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

Information Collection Provision: The 

information collection provisions of this 

proposed rule have been submitted to 

OMB for review. Interested persons are 

requested to fax comments regarding 

information collection by April 29, 

2010, to the Office of Information and 

Regulatory Affairs, OMB. To ensure that 

comments on information collection are 

received, OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, Jr., Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Constituent materials regulated under 

§ 610.15 (21 CFR 610.15) include 

ingredients, preservatives, diluents, 

adjuvants, extraneous protein and 

antibiotics that are contained in a 

biological product. FDA is proposing to 

amend the regulation for constituent 

materials at § 610.15 to allow the 

Director of CBER or the Director of 

CDER, as appropriate, to approve an 

exception or alternative to the 

requirements under § 610.15, when data 

submitted with the exception or 

alternative establish the safety, purity, 

and potency of the biological product. 

This proposed rule provides 

manufacturers of biological products 

with flexibility, as appropriate, to 

employ advances in science and 

technology as they become available, 

without diminishing public health 

protections. Examples of how the 

proposed rule would provide flexibility 

to manufacturers in the use of 

preservatives and aluminum in 

biological products are provided below. 

However, the proposed rule would also 

provide flexibility to the existing 

requirements regarding extraneous 

protein and antibiotics (§ 610.15(b) and 

(c)), provided that each request for an 

alternative or exception to these 

requirements is submitted with data that 

establish the safety, purity, and potency 

of the biological product. 

Standards for certain constituent 

materials present in biological products 

are provided under § 610.15. Section 

610.15(a) requires that all ingredients 

used in a licensed product, and any 

diluent provided as an aid in the 

administration of the product, meet 

generally accepted standards of purity 

and quality. Any preservative used shall 

be sufficiently nontoxic so that the 

amount present in the recommended 

dose of the product will not be toxic to 

the recipient, and in the combination 

used it shall not denature the specific 

substances in the product to result in a 

decrease below the minimum acceptable 

potency within the dating period when 

stored at the recommended temperature. 

Products in multiple-dose containers 

shall contain a preservative, except that 

a preservative need not be added to 

Yellow Fever Vaccine; Poliovirus 

Vaccine Live Oral; viral vaccines 

labeled for use with the jet injector; 

dried vaccines when the accompanying 

diluent contains a preservative; or to an 

Allergenic Product in 50 percent or 

more volume in volume glycerin. An 

adjuvant shall not be introduced into a 

product unless there is satisfactory 

evidence that it does not affect 

adversely the safety or potency of the 

product. 

These regulations also require that the 

amount of aluminum in the 

recommended individual dose of a 

biological product not exceed the 

following: 

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