Review of Commission's Regulations; Request for Comments and Information, 64865-64868 [2011-26820]

Download as PDF Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules proposes to amend part 43 of Title 14, Code of Federal Regulations, as follows: CONSUMER PRODUCT SAFETY COMMISSION PART 43—MAINTENANCE, PREVENTIVE MAINTENANCE, REBUILDING, AND ALTERATION [Docket No. CPSC–2011–0078] 16 CFR Chapter II Review of Commission’s Regulations; Request for Comments and Information 1. The authority citation for part 43 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701, 44703, 44705, 44707, 44711, 44713, 44717, 44725. 2. Amend § 43.3 by adding paragraph (k) to read as follows: § 43.3 Persons authorized to perform maintenance, preventive maintenance, rebuilding, and alterations. * * * * * (k) The holder of a pilot certificate issued under part 61 of this chapter may perform updating of self-contained, front-instrument panel-mounted and pedestal-mounted air traffic control (ATC) navigational system databases (excluding those of automatic flight control systems, transponders, and microwave frequency distance measuring equipment (DME), and any updates that affect system operating software) provided— (1) No disassembly of the unit is required; (2) The pilot has written procedures available to perform and evaluate the accomplishment of the task; and (3) The database is contained in a field-loadable configuration and imaged on a medium, such as a Compact Disc Read-Only Memory (CD–ROM), Synchronous Dynamic Random-Access Memory (SDRAM), or other nonvolatile memory that contains database files that are non-corruptible upon loading, and where integrity of the load can be assured and verified by the pilot upon completing the loading sequences. (4) Records of when such database uploads have occurred, the revision number of the software, and who performed the upload must be maintained. (5) The data to be uploaded must not contain system operating software revisions. srobinson on DSK4SPTVN1PROD with PROPOSALS Appendix A to Part 43 [Amended] 3. Amend Appendix A to part 43 by removing paragraph (c)(32). Issued in Washington, DC, on August 31, 2011. John W. McGraw, Deputy Director, Flights Standards Service. [FR Doc. 2011–27036 Filed 10–18–11; 8:45 am] BILLING CODE 4910–13–P VerDate Mar<15>2010 16:22 Oct 18, 2011 Jkt 226001 Consumer Product Safety Commission. ACTION: Request for comments and information. AGENCY: Consumer Product Safety Commission (‘‘CPSC’’ or ‘‘we’’) staff is considering the appropriate process and substance of a plan to review existing CPSC regulations. CPSC has conducted reviews of rules in the past and intends to build on that experience to develop a plan of review that also satisfies recent direction from President Obama, set forth in Executive Order 13579, ‘‘Regulation and Independent Regulatory Agencies’’ (76 FR 41587 (July 14, 2011)), which states that independent regulatory agencies should follow certain key principles when developing new regulations and should review existing significant regulations. To that end, Executive Order 13579 (‘‘E.O. 13579’’) emphasizes the importance of retrospective analysis of rules and the need to develop a plan under which the agency will conduct periodic reviews of existing regulations. We invite comments on the issues discussed in this document to help us formulate a plan that builds on our past review efforts while incorporating the principles outlined in E.O. 13579. DATES: Comments must be submitted by December 19, 2011. ADDRESSES: You may submit comments, identified by Docket No. CPSC–2011– 0078, by any of the following methods: SUMMARY: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (e-mail), except through https://www.regulations.gov. Written Submissions Submit written submissions in the following way: Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions), preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 64865 Highway, Bethesda, MD 20814; telephone (301) 504–7923. Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided to: https://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing and marked as confidential. Docket: For access to the docket to read background documents or comments received, go to: https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Robert J. Howell, Deputy Executive Director for Safety Operations, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, Maryland 20814; telephone (301) 504– 7621; e-mail rhowell@cpsc.gov. SUPPLEMENTARY INFORMATION: A. Previous Review Programs 1. The Systematic Review Program (2004 to 2007) In 2004, CPSC began a program to review existing regulations. This review resulted from an initiative by the Office of Management and Budget (‘‘OMB’’), the Program Assessment Rating Tool (‘‘PART’’), which was intended to provide a consistent approach to rating programs across the federal government. OMB recommended that the CPSC develop a plan to systematically review its regulations to ensure consistency among them in accomplishing program goals. In fiscal year (FY) 2004, we conducted a pilot review program as the initial step in implementing that recommendation. The notice announcing the pilot program appeared in the Federal Register on January 28, 2004 (69 FR 4095), and we continued the program for several years thereafter (see 70 FR 18338 (April 11, 2005); 71 FR 32882 (June 7, 2006); 72 FR 40265 (July 24, 2007)). The rule review focused on determining whether the CPSC’s regulations were: • Consistent with CPSC’s program goals; • Consistent with other CPSC regulations; • Current with respect to technology, economic, or market conditions, and other mandatory or voluntary standards; and E:\FR\FM\19OCP1.SGM 19OCP1 srobinson on DSK4SPTVN1PROD with PROPOSALS 64866 Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules • Subject to revision to reduce regulatory burdens, particularly burdens on small entities. See 69 FR 4096. When choosing which rules to review, the CPSC decided to exclude from review any rules that it considered nonsubstantive (i.e., those with requirements that were: administrative or procedural; exemptions; labeling; test methods; or definitions). The CPSC used the following criteria to select rules for the 2004 pilot program: (1) The rule had been in effect at least 10 years; (2) at least one of the rules selected for review had multiple requirements; (3) the rules addressed different hazard areas to ensure the review process was not overly burdensome to any one internal discipline; and (4) the rules were issued under different statutes. Once the rules were chosen, CPSC staff reviewed the rule to look for: Inconsistencies within the rule or with other CPSC rules; references to, or use of, obsolete standards, technology, procedures, or requirements that were no longer needed; and the potential to streamline requirements of the rule. Following that analysis, CPSC staff prepared a memo for the Commission’s consideration, discussing these issues and noted areas where changes to the rule were needed. This approach was followed for the review program in 2004 through 2007. The rules reviewed in the 2004 pilot included the safety standard for walkbehind mowers; requirements for electrically operated toys; the standard for the flammability of vinyl plastic film; and the child-resistant packaging requirements for aspirin and methyl salicylate. 69 FR 4095 (Jan. 28, 2004). In FY 2005, the CPSC reviewed the safety standard for cigarette lighters and multipurpose lighters; the requirements for bicycles; the standards for surface flammability of carpets and rugs; and the regulations requiring child-resistant packaging for oral subscription drugs subject to the Comprehensive Drug Abuse Prevention and Control Act. 70 FR 18338 (April 11, 2005). In FY 2006, the CPSC reviewed the safety standard for matchbooks; the requirements for toy rattles; and the requirements for baby bouncers, walker-jumpers, or baby walkers. 71 FR 32882 (June 7, 2006). In FY 2007, the CPSC reviewed the ban of unstable refuse bins and the requirements for pacifiers. 72 FR 40265 (July 24, 2007). In 2008, the enactment of the Consumer Product Safety Improvement Act of 2008 (Pub. L. 110–314) required us to assign resources to implement the new law. Consequently, we have not VerDate Mar<15>2010 16:22 Oct 18, 2011 Jkt 226001 pursued additional systematic rule reviews since 2007. 2. Periodic Review Under the Regulatory Flexibility Act In addition to the Systematic Review Program discussed in the previous section, the CPSC conducts reviews of rules in accordance with the Regulatory Flexibility Act (‘‘RFA’’). The RFA directs agencies to publish in the Federal Register, a ‘‘plan for the periodic review of the rules issued by the agency which have or will have a significant economic impact on a substantial number of small entities.’’ 5 U.S.C. 610(c). The plan must ‘‘provide for the review of all such agency rules existing on the effective date of [the RFA] within ten years’’ of that date and for the review of such rules adopted after the RFA’s effective date within 10 years of the publication of such rules. (The RFA took effect on January 1, 1981.) The review is to ‘‘determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact of the rules upon a substantial number of such small entities.’’ The review must consider: • The continued need for the rule; • The nature of complaints or comments concerning the rule received from the public; • The complexity of the rule; • The extent to which the rule overlaps, duplicates or conflicts with other Federal rules, and, to the extent feasible, with state and local governmental rules; and • The length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Furthermore, each year, an agency must publish in the Federal Register a list of the rules that have a significant economic impact on a substantial number of small entities. The list must include a brief description of each rule and the need for and legal basis of such rule, and public comment upon the rule must be invited. We published both our plan for review under the RFA and the list of rules in the Federal Register on August 14, 1981 (46 FR 45621). The plan contemplated a two-part review process: (a) a review of CPSC regulations that were in existence on the effective date of the RFA (January 1, 1981), and (b) a second review process for regulations issued after January 1, 1981. The plan provided that the first part of the review PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 process (for rules issued before January 1, 1981) would run from 1981 to 1987, and the second part of the process (for regulations issued after that date) would run from 1986 through 1991. In general, the plan stated that we would invite comments from all interested parties on our regulations, review the comments, and consider staff recommendations for appropriate administrative action for those regulations that have a significant economic impact on a substantial number of small entities. The plan further indicated that Commission action based on the recommendations would be consistent with the objectives of the statute(s) under which the regulations were issued. The CPSC reviewed the rules it had issued before the RFA took effect in 1981 and found that none of them had a significant economic impact on a substantial number of small entities. After the RFA took effect, the CPSC reviewed the potential impact on small entities whenever it issued a proposed and final rule. Few of the CPSC’s rules had a significant economic impact on a substantial number of small entities when they were issued. Therefore, few of CPSC’s rules warrant section 610 reviews. 3. Retrospective Analysis of Existing Regulations Under Executive Orders 13563 and 13579 On January 18, 2011, President Barack Obama issued Executive Order (‘‘E.O.’’) 13563, ‘‘Improving Regulation and Regulatory Review’’ (76 FR 3821 (January 21, 2011)), which articulated certain principles of regulation and directed agencies to take certain actions to promote those principles, including a retrospective analysis of existing significant regulations. ‘‘Agency,’’ as defined in E.O 13563, does not include independent agencies. On July 11, 2011, the President issued E.O. 13579, which applies to independent agencies such as the CPSC. Section 2 of E.O. 13579 states: ‘‘To facilitate the periodic review of existing significant regulations, independent regulatory agencies should consider how best to promote retrospective analysis of rules.’’ Further, E.O. 13579 directs that within 120 days, each independent regulatory agency should (consistent with law and reflecting the agency’s resources and regulatory priorities and processes) develop and provide to the public a plan for periodic review of existing significant rules. The retrospective analysis is to identify significant rules that ‘‘may be outmoded, ineffective, insufficient, or excessively burdensome.’’ The agency is to ‘‘modify, streamline, expand, or E:\FR\FM\19OCP1.SGM 19OCP1 Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules repeal’’ identified rules in accordance with what it learns through the review process. Both Executive Orders call for review of ‘‘significant regulations.’’ Neither order defines that term. However, E.O. 13563 supplements E.O. 12866, ‘‘Regulatory Planning and Review.’’ Although E.O. 12866 does not define ‘‘significant regulation,’’ it does define ‘‘significant regulatory action’’ as, among other things, ‘‘any regulatory action that is likely to result in a rule that may: Have an annual effect on the economy of $100 million or more or adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.’’ 1 58 FR 51375, 51378 (October 4, 1993). The CPSC has issued few rules that would be considered ‘‘significant’’ under this criterion. On July 22, 2011, OMB issued a memorandum providing guidance concerning E.O. 13579. This OMB memorandum states that the aim behind the retrospective review plans called for in E.O. 13579 is ‘‘to create a defined method and schedule for identifying certain significant rules that are obsolete, unnecessary, redundant, unjustified, excessively burdensome, or counterproductive,’’ but that ‘‘such review should also consider strengthening, complementing, or modernizing rules where necessary or appropriate—including, if relevant, undertaking new rulemaking.’’ The OMB memorandum identifies certain types of rules that would be good candidates for review, such as rules that ‘‘new technologies or unanticipated circumstances have overtaken’’ or that impose significant reporting or paperwork burdens.’’ The OMB memorandum recognizes that each agency should set its own priorities for review in its plan, ‘‘tailored to its specific mission, resources, organizational structure, and rulemaking history and volume.’’ The memorandum notes some topics that all plans might address, including: • Public participation: Solicit the public’s views, preferably before the agency develops its plan; srobinson on DSK4SPTVN1PROD with PROPOSALS 1 The additional criteria under E.O. 12866 that could make a regulatory action ‘‘significant’’ are: ‘‘create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive Order.’’ 58 FR 51378. These are not likely to come into play in the CPSC’s review of existing rules. VerDate Mar<15>2010 16:22 Oct 18, 2011 Jkt 226001 • Prioritization: Specify factors that will be considered in choosing rules for review and include an initial list of candidate rules for review over the next two years; • Analysis of costs and benefits and potential savings: Such analysis could be useful to identify rules where reforms could have the greatest potential for significant impact; • Structure and staff: Responsibility for review should be vested with a highlevel agency official and the plan should consider how to maintain sufficient independence from the offices that write and implement rules; and • Coordination with other forms of review: Coordinate with other programs in place to review existing rules (e.g., review under the RFA). B. Proceeding With Retrospective Review of Existing CPSC Rules In accordance with E.O. 13579, the CPSC is proceeding with review of existing CPSC rules. Chairman Inez Tenenbaum directed agency staff to reinvigorate the CPSC’s voluntary review process for existing rules. (See the Chairman’s statement posted on the CPSC’s Web site on July 11, 2011 (https://www.cpsc.gov/pr/regreform 07112011.html).) With this notice, we are seeking public comments and information to help us develop a plan for review of existing rules that will be appropriate to the agency, be consistent with (and not duplicate) previous and ongoing reviews, and fulfill the spirit of E.O. 13579. We intend for the CPSC’s review to be broader than the reviews contemplated by the RFA and the Executive Orders because we are not limiting our evaluation to only regulations that have a significant economic impact on a substantial number of small entities, nor are we limiting it to significant regulations, as defined in E.O. 12866. We invite comments on any aspects of the review discussed in this document and particularly concerning the following issues: 1. Selection of Rules for Review a. Criteria • What criteria should we use to select candidate rules for review? • Should we use any of the criteria that were used to select rules for the 2004 pilot project for CPSC’s Systematic Rule Review Program (these were: The rule has been in effect at least 10 years; at least one of the rules selected for review has multiple requirements; the rules address different hazard areas; and the rules were issued under different statutes)? PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 64867 • How should we identify rules that may be obsolete, unnecessary, redundant, unjustified, excessively burdensome, or counterproductive? Are there specific rules that commenters can identify? • How should we identify rules that may be in need of strengthening, complementing, modernizing, or, if relevant, undertaking new rulemaking? • How should we identify rules that may have been overtaken by new technologies or unanticipated circumstances, or that impose significant reporting or paperwork burdens? Are there specific rules that commenters can identify? b. Possible Exclusions • Should the review exclude rules that were excluded under the CPSC’s Systematic Rule Review Program (rules that are administrative or procedural; exemptions; labeling; test methods; or definitions)? • Are there other categories of rules that should be excluded? 2. Process of Review a. Timing • How should we determine the number of rules to be reviewed, and possibly revised, each year and at what intervals? • How should the number of rules reviewed, and possibly revised, each year be prioritized against other agency work? • Should different rules be reviewed at different intervals? Please explain. • Should the schedule for review be similar to that under section 610 of the RFA (i.e., a rule should be reviewed after it has been in effect for 10 years?) b. Public Participation • How should we involve the public in the review? • Should comments be requested for each rule reviewed? • Should we hold public meetings concerning the selection of rules for review? • Should there be public meetings related to each rule as it is reviewed? c. Coordination • How can we coordinate our review with reviews required by section 610 of the RFA and with reviews envisioned by E.O. 13579? • How can we coordinate better with other agencies and with other jurisdictions (such as states, other countries, and international bodies) to harmonize regulatory requirements and eliminate redundant or inconsistent regulations? E:\FR\FM\19OCP1.SGM 19OCP1 64868 Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules • How can we modify, streamline, or expand our regulatory review process? d. Prioritization • How should we prioritize rules that are to be reviewed (e.g., chronologically; based on rules where the greatest impact could be made from potential changes; rules with potential to have greatest savings in costs or paperwork/reporting burdens; rules with most potential for changes to enhance safety)? 3. Substance of Review • Should the review include any or all of the considerations in RFA reviews (i.e., continued need for the rule; nature of complaints or comments concerning the rule; complexity of the rule; extent of overlap or conflicts with other federal (and possibly state and local) rules; and length of time since the rule has been evaluated; or extent of change in technology, economic conditions, or other factors)? • Should we conduct cost-benefit analyses with every rule we review or only for significant rules as anticipated by the Executive Orders? Please explain your reasoning. Do commenters have suggestions for how we might develop our analysis of costs and benefits for rules under consideration for retrospective review? Dated: October 12, 2011. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. 2011–26820 Filed 10–18–11; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 316 [Docket No. FDA–2011–N–0583] RIN 0910–AG72 Orphan Drug Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued. srobinson on DSK4SPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:22 Oct 18, 2011 Jkt 226001 Submit either electronic or written comments on the proposed rule by January 17, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 18, 2011 (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: You may submit comments, identified by Docket No. FDA–2011–N– 0583 and/or RIN number 0910–AG72, 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). DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// 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. FDA–2011–N–0583 and Regulatory Information Number (RIN) 0910–AG72 for this rulemaking. All comments received may be posted without change to https:// 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 https:// 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. FOR FURTHER INFORMATION CONTACT: Erica K. McNeilly, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, Silver Spring, MD 20993, 301–796–8660. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 Table of Contents I. Background II. Description of the Proposed Changes A. Demonstration of an ‘‘Orphan Subset’’ of a Disease or Condition B. Eligibility for Orphan-Drug Designation of a Drug That Was Previously Approved for the Orphan Indication C. Eligibility for Multiple Orphan-Drug Exclusive Approvals D. Demonstration of Clinical Superiority E. Name of the Drug F. Required Drug Description and Scientific Rationale in a Request for Orphan-Drug Designation G. Removal of Requirement To Submit Statement as to Whether Sponsor Submitting the Request Is the Real Party in Interest H. Timing of Request for Orphan-Drug Designation I. Responding to a Deficiency Letter From FDA on an Orphan-Drug Designation Request J. Publication of Orphan-Drug Designations K. FDA Recognition of Orphan-Drug Exclusive Approval L. Miscellaneous Terminology Changes M. Address Change III. Environmental Impact IV. Legal Authority V. Proposed Implementation Plan VI. Executive Order 13132: Federalism VII. Paperwork Reduction Act of 1995 VIII. Analysis of Impacts A. Background B. Benefits and Costs of the Proposed Rule C. Small Business Analysis IX. Request for Comments I. Background Since the publication of the Orphan Drug Regulations in the Federal Register of December 29, 1992 (57 FR 62076), FDA has reviewed over 3,350 requests for orphan-drug designation of drugs for rare diseases and conditions. Based on these experiences, FDA believes it is useful to clarify certain regulatory language in the current orphan drug regulations and to propose areas of minor improvement. These amendments are intended to assist sponsors who are seeking and who have obtained orphan-drug designation of their drugs, as well as FDA in administering the orphan drug program. These amendments are consistent with the Orphan Drug Act (Pub. L. 97–414) and continue to provide incentives for the development of potentially promising orphan drugs that otherwise would not be developed for rare diseases and conditions. The specific issues addressed in this proposal include: (1) Demonstration of an appropriate ‘‘orphan subset’’ of persons with a particular disease or condition that otherwise affects 200,000 or more persons in the United States, for the purpose of designating a drug for use in that subset; (2) eligibility for E:\FR\FM\19OCP1.SGM 19OCP1

Agencies

[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Proposed Rules]
[Pages 64865-64868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26820]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2011-0078]

16 CFR Chapter II


Review of Commission's Regulations; Request for Comments and 
Information

AGENCY: Consumer Product Safety Commission.

ACTION: Request for comments and information.

-----------------------------------------------------------------------

SUMMARY: Consumer Product Safety Commission (``CPSC'' or ``we'') staff 
is considering the appropriate process and substance of a plan to 
review existing CPSC regulations. CPSC has conducted reviews of rules 
in the past and intends to build on that experience to develop a plan 
of review that also satisfies recent direction from President Obama, 
set forth in Executive Order 13579, ``Regulation and Independent 
Regulatory Agencies'' (76 FR 41587 (July 14, 2011)), which states that 
independent regulatory agencies should follow certain key principles 
when developing new regulations and should review existing significant 
regulations. To that end, Executive Order 13579 (``E.O. 13579'') 
emphasizes the importance of retrospective analysis of rules and the 
need to develop a plan under which the agency will conduct periodic 
reviews of existing regulations. We invite comments on the issues 
discussed in this document to help us formulate a plan that builds on 
our past review efforts while incorporating the principles outlined in 
E.O. 13579.

DATES: Comments must be submitted by December 19, 2011.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2011-
0078, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
    Federal eRulemaking Portal: https://www.regulations.gov. Follow the 
instructions for submitting comments.
    To ensure timely processing of comments, the Commission is no 
longer accepting comments submitted by electronic mail (e-mail), except 
through https://www.regulations.gov.

Written Submissions

    Submit written submissions in the following way:
    Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions), preferably in five copies, to: Office of the Secretary, 
Consumer Product Safety Commission, Room 820, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change, including any personal identifiers, contact 
information, or other personal information provided to: https://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
electronically. Such information should be submitted in writing and 
marked as confidential.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Robert J. Howell, Deputy Executive 
Director for Safety Operations, U.S. Consumer Product Safety 
Commission, 4330 East-West Highway, Bethesda, Maryland 20814; telephone 
(301) 504-7621; e-mail rhowell@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

A. Previous Review Programs

1. The Systematic Review Program (2004 to 2007)

    In 2004, CPSC began a program to review existing regulations. This 
review resulted from an initiative by the Office of Management and 
Budget (``OMB''), the Program Assessment Rating Tool (``PART''), which 
was intended to provide a consistent approach to rating programs across 
the federal government. OMB recommended that the CPSC develop a plan to 
systematically review its regulations to ensure consistency among them 
in accomplishing program goals. In fiscal year (FY) 2004, we conducted 
a pilot review program as the initial step in implementing that 
recommendation. The notice announcing the pilot program appeared in the 
Federal Register on January 28, 2004 (69 FR 4095), and we continued the 
program for several years thereafter (see 70 FR 18338 (April 11, 2005); 
71 FR 32882 (June 7, 2006); 72 FR 40265 (July 24, 2007)).
    The rule review focused on determining whether the CPSC's 
regulations were:
     Consistent with CPSC's program goals;
     Consistent with other CPSC regulations;
     Current with respect to technology, economic, or market 
conditions, and other mandatory or voluntary standards; and

[[Page 64866]]

     Subject to revision to reduce regulatory burdens, 
particularly burdens on small entities.

See 69 FR 4096. When choosing which rules to review, the CPSC decided 
to exclude from review any rules that it considered nonsubstantive 
(i.e., those with requirements that were: administrative or procedural; 
exemptions; labeling; test methods; or definitions).
    The CPSC used the following criteria to select rules for the 2004 
pilot program: (1) The rule had been in effect at least 10 years; (2) 
at least one of the rules selected for review had multiple 
requirements; (3) the rules addressed different hazard areas to ensure 
the review process was not overly burdensome to any one internal 
discipline; and (4) the rules were issued under different statutes. 
Once the rules were chosen, CPSC staff reviewed the rule to look for: 
Inconsistencies within the rule or with other CPSC rules; references 
to, or use of, obsolete standards, technology, procedures, or 
requirements that were no longer needed; and the potential to 
streamline requirements of the rule. Following that analysis, CPSC 
staff prepared a memo for the Commission's consideration, discussing 
these issues and noted areas where changes to the rule were needed. 
This approach was followed for the review program in 2004 through 2007.
    The rules reviewed in the 2004 pilot included the safety standard 
for walk-behind mowers; requirements for electrically operated toys; 
the standard for the flammability of vinyl plastic film; and the child-
resistant packaging requirements for aspirin and methyl salicylate. 69 
FR 4095 (Jan. 28, 2004). In FY 2005, the CPSC reviewed the safety 
standard for cigarette lighters and multipurpose lighters; the 
requirements for bicycles; the standards for surface flammability of 
carpets and rugs; and the regulations requiring child-resistant 
packaging for oral subscription drugs subject to the Comprehensive Drug 
Abuse Prevention and Control Act. 70 FR 18338 (April 11, 2005). In FY 
2006, the CPSC reviewed the safety standard for matchbooks; the 
requirements for toy rattles; and the requirements for baby bouncers, 
walker-jumpers, or baby walkers. 71 FR 32882 (June 7, 2006). In FY 
2007, the CPSC reviewed the ban of unstable refuse bins and the 
requirements for pacifiers. 72 FR 40265 (July 24, 2007).
    In 2008, the enactment of the Consumer Product Safety Improvement 
Act of 2008 (Pub. L. 110-314) required us to assign resources to 
implement the new law. Consequently, we have not pursued additional 
systematic rule reviews since 2007.

2. Periodic Review Under the Regulatory Flexibility Act

    In addition to the Systematic Review Program discussed in the 
previous section, the CPSC conducts reviews of rules in accordance with 
the Regulatory Flexibility Act (``RFA''). The RFA directs agencies to 
publish in the Federal Register, a ``plan for the periodic review of 
the rules issued by the agency which have or will have a significant 
economic impact on a substantial number of small entities.'' 5 U.S.C. 
610(c). The plan must ``provide for the review of all such agency rules 
existing on the effective date of [the RFA] within ten years'' of that 
date and for the review of such rules adopted after the RFA's effective 
date within 10 years of the publication of such rules. (The RFA took 
effect on January 1, 1981.)
    The review is to ``determine whether such rules should be continued 
without change, or should be amended or rescinded, consistent with the 
stated objectives of applicable statutes, to minimize any significant 
economic impact of the rules upon a substantial number of such small 
entities.'' The review must consider:
     The continued need for the rule;
     The nature of complaints or comments concerning the rule 
received from the public;
     The complexity of the rule;
     The extent to which the rule overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
state and local governmental rules; and
     The length of time since the rule has been evaluated or 
the degree to which technology, economic conditions, or other factors 
have changed in the area affected by the rule.

    Furthermore, each year, an agency must publish in the Federal 
Register a list of the rules that have a significant economic impact on 
a substantial number of small entities. The list must include a brief 
description of each rule and the need for and legal basis of such rule, 
and public comment upon the rule must be invited.
    We published both our plan for review under the RFA and the list of 
rules in the Federal Register on August 14, 1981 (46 FR 45621). The 
plan contemplated a two-part review process: (a) a review of CPSC 
regulations that were in existence on the effective date of the RFA 
(January 1, 1981), and (b) a second review process for regulations 
issued after January 1, 1981. The plan provided that the first part of 
the review process (for rules issued before January 1, 1981) would run 
from 1981 to 1987, and the second part of the process (for regulations 
issued after that date) would run from 1986 through 1991. In general, 
the plan stated that we would invite comments from all interested 
parties on our regulations, review the comments, and consider staff 
recommendations for appropriate administrative action for those 
regulations that have a significant economic impact on a substantial 
number of small entities. The plan further indicated that Commission 
action based on the recommendations would be consistent with the 
objectives of the statute(s) under which the regulations were issued.
    The CPSC reviewed the rules it had issued before the RFA took 
effect in 1981 and found that none of them had a significant economic 
impact on a substantial number of small entities. After the RFA took 
effect, the CPSC reviewed the potential impact on small entities 
whenever it issued a proposed and final rule. Few of the CPSC's rules 
had a significant economic impact on a substantial number of small 
entities when they were issued. Therefore, few of CPSC's rules warrant 
section 610 reviews.

3. Retrospective Analysis of Existing Regulations Under Executive 
Orders 13563 and 13579

    On January 18, 2011, President Barack Obama issued Executive Order 
(``E.O.'') 13563, ``Improving Regulation and Regulatory Review'' (76 FR 
3821 (January 21, 2011)), which articulated certain principles of 
regulation and directed agencies to take certain actions to promote 
those principles, including a retrospective analysis of existing 
significant regulations. ``Agency,'' as defined in E.O 13563, does not 
include independent agencies.
    On July 11, 2011, the President issued E.O. 13579, which applies to 
independent agencies such as the CPSC. Section 2 of E.O. 13579 states: 
``To facilitate the periodic review of existing significant 
regulations, independent regulatory agencies should consider how best 
to promote retrospective analysis of rules.'' Further, E.O. 13579 
directs that within 120 days, each independent regulatory agency should 
(consistent with law and reflecting the agency's resources and 
regulatory priorities and processes) develop and provide to the public 
a plan for periodic review of existing significant rules. The 
retrospective analysis is to identify significant rules that ``may be 
outmoded, ineffective, insufficient, or excessively burdensome.'' The 
agency is to ``modify, streamline, expand, or

[[Page 64867]]

repeal'' identified rules in accordance with what it learns through the 
review process.
    Both Executive Orders call for review of ``significant 
regulations.'' Neither order defines that term. However, E.O. 13563 
supplements E.O. 12866, ``Regulatory Planning and Review.'' Although 
E.O. 12866 does not define ``significant regulation,'' it does define 
``significant regulatory action'' as, among other things, ``any 
regulatory action that is likely to result in a rule that may: Have an 
annual effect on the economy of $100 million or more or adversely 
affect, in a material way, the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities.'' \1\ 58 
FR 51375, 51378 (October 4, 1993). The CPSC has issued few rules that 
would be considered ``significant'' under this criterion.
---------------------------------------------------------------------------

    \1\ The additional criteria under E.O. 12866 that could make a 
regulatory action ``significant'' are: ``create a serious 
inconsistency or otherwise interfere with an action taken or planned 
by another agency; materially alter the budgetary impact of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or raise novel or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order.'' 58 FR 51378. These 
are not likely to come into play in the CPSC's review of existing 
rules.
---------------------------------------------------------------------------

    On July 22, 2011, OMB issued a memorandum providing guidance 
concerning E.O. 13579. This OMB memorandum states that the aim behind 
the retrospective review plans called for in E.O. 13579 is ``to create 
a defined method and schedule for identifying certain significant rules 
that are obsolete, unnecessary, redundant, unjustified, excessively 
burdensome, or counterproductive,'' but that ``such review should also 
consider strengthening, complementing, or modernizing rules where 
necessary or appropriate--including, if relevant, undertaking new 
rulemaking.'' The OMB memorandum identifies certain types of rules that 
would be good candidates for review, such as rules that ``new 
technologies or unanticipated circumstances have overtaken'' or that 
impose significant reporting or paperwork burdens.''
    The OMB memorandum recognizes that each agency should set its own 
priorities for review in its plan, ``tailored to its specific mission, 
resources, organizational structure, and rulemaking history and 
volume.'' The memorandum notes some topics that all plans might 
address, including:
     Public participation: Solicit the public's views, 
preferably before the agency develops its plan;
     Prioritization: Specify factors that will be considered in 
choosing rules for review and include an initial list of candidate 
rules for review over the next two years;
     Analysis of costs and benefits and potential savings: Such 
analysis could be useful to identify rules where reforms could have the 
greatest potential for significant impact;
     Structure and staff: Responsibility for review should be 
vested with a high-level agency official and the plan should consider 
how to maintain sufficient independence from the offices that write and 
implement rules; and
     Coordination with other forms of review: Coordinate with 
other programs in place to review existing rules (e.g., review under 
the RFA).

B. Proceeding With Retrospective Review of Existing CPSC Rules

    In accordance with E.O. 13579, the CPSC is proceeding with review 
of existing CPSC rules. Chairman Inez Tenenbaum directed agency staff 
to reinvigorate the CPSC's voluntary review process for existing rules. 
(See the Chairman's statement posted on the CPSC's Web site on July 11, 
2011 (https://www.cpsc.gov/pr/regreform07112011.html).)
    With this notice, we are seeking public comments and information to 
help us develop a plan for review of existing rules that will be 
appropriate to the agency, be consistent with (and not duplicate) 
previous and ongoing reviews, and fulfill the spirit of E.O. 13579. We 
intend for the CPSC's review to be broader than the reviews 
contemplated by the RFA and the Executive Orders because we are not 
limiting our evaluation to only regulations that have a significant 
economic impact on a substantial number of small entities, nor are we 
limiting it to significant regulations, as defined in E.O. 12866.
    We invite comments on any aspects of the review discussed in this 
document and particularly concerning the following issues:

1. Selection of Rules for Review

a. Criteria
     What criteria should we use to select candidate rules for 
review?
     Should we use any of the criteria that were used to select 
rules for the 2004 pilot project for CPSC's Systematic Rule Review 
Program (these were: The rule has been in effect at least 10 years; at 
least one of the rules selected for review has multiple requirements; 
the rules address different hazard areas; and the rules were issued 
under different statutes)?
     How should we identify rules that may be obsolete, 
unnecessary, redundant, unjustified, excessively burdensome, or 
counterproductive? Are there specific rules that commenters can 
identify?
     How should we identify rules that may be in need of 
strengthening, complementing, modernizing, or, if relevant, undertaking 
new rulemaking?
     How should we identify rules that may have been overtaken 
by new technologies or unanticipated circumstances, or that impose 
significant reporting or paperwork burdens? Are there specific rules 
that commenters can identify?
b. Possible Exclusions
     Should the review exclude rules that were excluded under 
the CPSC's Systematic Rule Review Program (rules that are 
administrative or procedural; exemptions; labeling; test methods; or 
definitions)?
     Are there other categories of rules that should be 
excluded?

2. Process of Review

a. Timing
     How should we determine the number of rules to be 
reviewed, and possibly revised, each year and at what intervals?
     How should the number of rules reviewed, and possibly 
revised, each year be prioritized against other agency work?
     Should different rules be reviewed at different intervals? 
Please explain.
     Should the schedule for review be similar to that under 
section 610 of the RFA (i.e., a rule should be reviewed after it has 
been in effect for 10 years?)
b. Public Participation
     How should we involve the public in the review?
     Should comments be requested for each rule reviewed?
     Should we hold public meetings concerning the selection of 
rules for review?
     Should there be public meetings related to each rule as it 
is reviewed?
c. Coordination
     How can we coordinate our review with reviews required by 
section 610 of the RFA and with reviews envisioned by E.O. 13579?
     How can we coordinate better with other agencies and with 
other jurisdictions (such as states, other countries, and international 
bodies) to harmonize regulatory requirements and eliminate redundant or 
inconsistent regulations?

[[Page 64868]]

     How can we modify, streamline, or expand our regulatory 
review process?
d. Prioritization
     How should we prioritize rules that are to be reviewed 
(e.g., chronologically; based on rules where the greatest impact could 
be made from potential changes; rules with potential to have greatest 
savings in costs or paperwork/reporting burdens; rules with most 
potential for changes to enhance safety)?

3. Substance of Review

     Should the review include any or all of the considerations 
in RFA reviews (i.e., continued need for the rule; nature of complaints 
or comments concerning the rule; complexity of the rule; extent of 
overlap or conflicts with other federal (and possibly state and local) 
rules; and length of time since the rule has been evaluated; or extent 
of change in technology, economic conditions, or other factors)?
     Should we conduct cost-benefit analyses with every rule we 
review or only for significant rules as anticipated by the Executive 
Orders? Please explain your reasoning. Do commenters have suggestions 
for how we might develop our analysis of costs and benefits for rules 
under consideration for retrospective review?

    Dated: October 12, 2011.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2011-26820 Filed 10-18-11; 8:45 am]
BILLING CODE 6355-01-P
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