Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules 64865 

proposes to amend part 43 of Title 14, 

Code of Federal Regulations, as follows: 

PART 43—MAINTENANCE, 

PREVENTIVE MAINTENANCE, 

REBUILDING, AND ALTERATION 

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. 

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 

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: http:// 

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 

http://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: 

http://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: http:// 

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 


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 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS
Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Proposed Rules 64867 

1The 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. 

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; 

• 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 

(http://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)? 

• 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? 


srobinson on DSK4SPTVN1PROD with PROPOSALS
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. 

SUMMARY: 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. 

DATES: 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). 

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. FDA–2011–N–0583 and 

Regulatory Information Number (RIN) 

0910–AG72 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. 

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: 

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 


srobinson on DSK4SPTVN1PROD with PROPOSALS