61830 Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Notices 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing premarket 

notification submissions (21 CFR part 

807, subpart E, OMB control number 

0910–0120). The labeling provisions 

addressed in the guidance have been 

approved by OMB under OMB control 

number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Comments 

received may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 17, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–21349 Filed 10–25–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2002D–0307] (formerly 02D–

0307) 

Guidance for Industry on Potassium 

Chloride Modified-Release Tablets and 

Capsules: In Vivo Bioequivalence and 

In Vitro Dissolution Testing; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Potassium Chloride ModifiedRelease Tablets and Capsules: In Vivo 

Bioequivalence and In Vitro Dissolution 

Testing.’’ This guidance document 

provides recommendations to sponsors 

of abbreviated new drug applications 

(ANDAs) on the design of 

bioequivalence studies for modifiedrelease dosage forms of potassium 

chloride. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Lizzie Sanchez, Center for Drug 

Evaluation and Research (HFD–650), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5847. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Potassium Chloride Modified-Release 

Tablets and Capsules: In Vivo 

Bioequivalence and In Vitro Dissolution 

Testing.’’ This guidance is intended to 

provide information to sponsors of 

ANDAs on the design of bioequivalence 

studies for modified-release dosage 

forms of potassium chloride. 

A document entitled ‘‘Guidance for In 

Vivo Bioequivalence Study for SlowRelease Potassium Chloride Tablets/ 

Capsules’’ was issued on May 15, 1987 

(1987 guidance), and revised on June 6, 

1994 (1994 revision). The guidance was 

further revised to incorporate FDA’s 

current thinking on the bioequivalence 

requirements for potassium chloride 

modified-release products and was 

issued in draft on August 7, 2002 (2002 

draft guidance) (67 FR 51284). 

Comments were reviewed and 

incorporated. The most substantive 

changes made are described in the 

following paragraphs. Editorial changes 

were also made and the final guidance 

is now available. 

In the 2002 draft guidance, the agency 

recommended a three-way crossover 

design study comparing the reference 

listed drug (RLD) to both the generic 

product and a solution of potassium 

chloride. The 2002 draft guidance also 

recommended analysis of covariance 

(ANCOVA) for the pharmacokinetic 

parameters. 

The final guidance provides 

recommendations for a two-way 

crossover design comparing the generic 

product to the RLD. This design is 

consistent with the 1994 revision, 

which stated that the potassium 

chloride solution mentioned in the 1987 

guidance was no longer necessary and 

recommended the use of a twotreatment, two-period, single-dose, 

fasting study comparing test product 

with reference product. The FDA 

determined that the potassium chloride 

solution arm is not necessary because 

the objective of the bioequivalence 

study is to directly compare the rate and 

extent of potassium absorption from the 

test product and the reference product. 

Therefore, the potassium chloride 

solution arm is not necessary for the 

test-versus-reference comparison and 

adds unnecessary complexity to the 

statistical bioequivalance analysis. 

We also have decided not to 

recommend the use of ANCOVA in the 

final guidance. Analysis of variance 

(ANOVA) with baseline correction is 

adequate for bioequivalence analysis of 

pharmacokinetic data obtained 

following oral administration of 

potassium chloride drug products. The 

FDA concluded that using ANCOVA 

with baseline as a covariate to analyze 

baseline-uncorrected data was not as 

sensitive to changes in formulation 

performance as using ANOVA to 

analyze baseline-corrected data. 

The dissolution testing and criteria for 

waivers on in vivo testing for lower 

strengths are revised to reflect the 

changes outlined in the guidance 

entitled ‘‘Bioavailability and 

Bioequivalence Studies for Orally 

Administered Drug Products—General 

Considerations,’’ available on the 

Internet at http://www.fda.gov/cder/ 

guidance/index.htm. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on studies to 

demonstrate the bioequivalence of 

potassium chloride modified-release 

tablets and capsules. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance at any time. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Notices 61831 

docket number found in brackets in the 

heading of this document. The guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: October 18, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21347 Filed 10–25–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

[Docket No. TSA–2005–21866] 

Extension Agency Information 

Collection Activity Under OMB Review: 

Enhanced Security Procedures at 

Ronald Reagan National Airport (DCA) 

AGENCY: Transportation Security 

Administration (TSA), DHS. 

ACTION: Notice. 

SUMMARY: This notice announces that 

TSA has forwarded the Information 

Collection Request (ICR) abstracted 

below to the Office of Management and 

Budget (OMB) for review and approval 

of an extension of the currently 

approved collection under the 

Paperwork Reduction Act. The ICR 

describes the nature of the information 

collection and its expected burden. TSA 

published a Federal Register notice, 

with a 60-day comment period soliciting 

comments, of the following collection of 

information on August 26, 2005, 70 FR 

50391. 

DATES: Send your comments by 

November 25, 2005. A comment to OMB 

is most effective if OMB receives it 

within 30 days of publication. 

ADDRESSES: Comments may be faxed to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Attention: DHS–TSA Desk 

Officer, at (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Katrina Wawer, Information Collection 

Specialist, Office of Transportation 

Security Policy, TSA–9, Transportation 

Security Administration, 601 South 

12th Street, Arlington, VA 22202–4220. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

In accordance with the Paperwork 

Reduction Act of 1995, (44 U.S.C. 3501 

et seq.), an agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information, 

unless it displays a valid OMB control 

number. Therefore, in preparation for 

OMB review and approval of the 

following information collection, TSA is 

soliciting comments to—

(1) Evaluate whether the proposed 

information requirement is necessary for 

the proper performance of the functions 

of the agency, including whether the 

information will have practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including using 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Information Collection Requirement 

Title: Enhanced Security Procedures 

at Ronald Reagan National Airport 

(DCA). 

Type of Request: Extension of a 

currently approved collection. 

OMB Control Number: 1652–0035. 

Forms(s): ‘‘Flight Authorization 

Request Form,’’ ‘‘Armed Security 

Officer Nomination Form,’’ ‘‘FBO and 

Operator Initial Information Survey.’’

Affected Public: General aviation 

aircraft operators, crewmembers, and 

passengers. 

Abstract: On July 19, 2005, TSA 

published an interim final rule (IFR) to 

restore access to Ronald Reagan 

National Airport (DCA) for certain 

aircraft operations while maintaining 

the security of critical Federal 

Government and other assets in the 

Washington, DC metropolitan area. The 

IFR amended 49 CFR part 1562 by 

adding a new subpart B entitled Ronald 

Reagan-Washington National Airport: 

Enhanced Security Procedures for 

Certain Operations. The IFR and this 

information collection apply to all 

passenger aircraft operations into or out 

of DCA, except U.S. air carrier 

operations operating under a full 

security program required by 49 CFR 

part 1544 and foreign air carrier 

operations operating under 49 CFR 

1546.101(a) or (b). TSA requires 

individuals designated as security 

coordinators by Fixed Based Operators 

(FBOs) and general aviation aircraft, 

flight crewmembers who operate general 

aviation aircraft into and out of DCA in 

accordance with the IFR, and armed 

security officers (ASOs) approved in 

accordance with the IFR to submit 

fingerprints and other identifying 

information. In addition, general 

aviation aircraft operators are required 

to provide TSA with identifying 

information for all individuals onboard 

each aircraft that operates into and out 

of DCA. General aviation aircraft 

operators also are required to provide 

TSA with the flight plan and 

registration number of their aircraft that 

will operate to or from DCA. Finally, 

aircraft operators and FBOs are required 

to nominate the individuals they would 

like to be qualified as ASOs by 

submitting an ASO Nomination Form to 

TSA. Once nominated, the ASOs are 

required to submit identifying 

information, as well as employment 

history information, by completing an 

on-line application. 

Number of Respondents: 2,025. 

Estimated Annual Burden Hours: An 

estimated 13,298 hours annually. 

Issued in Arlington, Virginia, on October 

19, 2005. 

Lisa S. Dean, 

Privacy Officer. 

[FR Doc. 05–21364 Filed 10–25–05; 8:45 am] 

BILLING CODE 4910–62–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[CIS No. 2352–05] 

RIN 1615–ZA23 

Adjustment of the Immigration Benefit 

Application Fee Schedule; Correction 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: Notice of correction. 

SUMMARY: U.S. Citizenship and 

Immigration Services (USCIS) published 

a notice in the Federal Register on 

September 26, 2005 at 70 FR 56182 to 

increase the fees for immigration benefit 

applications and petitions to account for 

cost increases due to inflation. In the fee 

table of the September 26, 2005 notice, 

USCIS added a footnote ‘‘6’’ next to the 

new fee for the Form N–600K. Footnote 

‘‘6’’ shows an increase in fee from $200 

to $215 for an application filed on 

behalf of an adopted child (as compared 

to the base fee increase from $240 to 

$255). The placement of this footnote 

and its lack of specificity regarding 

which ‘‘application’’ it was meant to