Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30577 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on July 27, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: June 18, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–15189 Filed 6–25–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; NCCAM Customer Service 

Data Collection 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Center for Complementary and 

Alternative Medicine (NCCAM), at the 

National Institutes of Health (NIH), will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: NCCAM 

Customer Service Data Collection. Type 

of Information Collection Request: 

Revision. Need and Use of Information 

Collection: NCCAM provides the public, 

patients, families, health care providers, 

complementary and alternative 

medicine (CAM) practitioners, and 

others with the latest scientifically 

based information on CAM and 

information about NCCAM’s programs 

through a variety of channels, including 

its toll-free telephone information 

service and its quarterly newsletter. To 

ensure that NCCAM is effectively 

serving all audiences, NCCAM needs to 

continue to measure customer 

satisfaction with NCCAM telephone 

interactions. This effort involves a 

telephone survey consisting of 10 

questions, which are asked of 25 percent 

of all callers, for an annual total of 

approximately 1,210 respondents. 

NCCAM uses the data collected from the 

surveys to characterize NCCAM users 

and help program staff measure user 

satisfaction, assess impact of their 

communication efforts, tailor services to 

the public and health care providers, 

measure service use among special 

populations, and assess the most 

effective media and messages to reach 

these audiences. Frequency of Response: 

Once. Affected Public: Individuals and 

households. Type of Respondents: 

Patients, spouses/family/friends of 

patients, health care providers, 

physicians, CAM practitioners, or other 

individuals contacting the NCCAM 

Clearinghouse. 

The annual reporting burden is as 

follows. 

Type of respondents 

Estimated number of respondents 

Estimated number of responses per respondent 

Average burden 

hours per 

response 

Estimated total 

annual burden 

hours requested 

Telephone survey: 

Individuals or households ................................................................. 1,210 1 0.075 91 

The annualized cost to respondents is 

estimated at $1,770 for the telephone 

survey. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on the following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions; (3) Ways 

to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

For Further Information Contact: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, NCCAM, 31 Center 

Drive, Room 2B11, Bethesda, MD 

20892–2182; or fax your request to 301– 

402–4741; or e-mail 

thomsenc@mail.nih.gov. Ms. Thomsen 

can be contacted by telephone at 301– 

451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: June 18, 2009. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E9–15058 Filed 6–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0264] 

Amended Authorization of Emergency 

Use of Doxycycline Hyclate Tablet 

Emergency Kits for Eligible United 

States Postal Service Participants in 

the Cities Readiness Initiative and 

Their Household Members; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the Emergency Use 

Authorization (EUA) (the Authorization) 

for doxycycline hyclate tablet 

emergency kits for eligible U.S. Postal 

Service (USPS) participants in the Cities 

Readiness Initiative (CRI) and their 

household members issued on October 

3, 2008, under the Federal Food, Drug, 

and Cosmetic Act (the act), as requested 

by the Biomedical Advanced Research 

and Development Authority (BARDA), 

Office of the Assistant Secretary for 

Preparedness and Response (ASPR), 

30578 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

1BARDA submitted an amendment on October 3, 

2008. Following issuance of FDA’s October 3, 2008, 

authorization letter, BARDA submitted a request on 

behalf of the Office of the Assistant Secretary for 

Preparedness and Response (ASPR) on February 19, 

2009, to further amend the authorization. This 

amended authorization letter responds to that 

request. 

2 Your submissions refer to a Household 

Antibiotic Kit (HAK), which would be stored in an 

eligible United States Postal Service (USPS) 

participant’s home and would contain unit-of-use 

bottles of doxycycline hyclate tablets (100 mg) and 

both emergency use instructions and home 

preparation instructions. Your submissions also 

refer to an individual Household Antibiotic Kit 

(iHAK), which would be stored at an eligible USPS 

participant’s workplace and would contain only 

one unit-of-use bottle of doxycycline hyclate tablets 

(100 mg) and emergency use instructions. For ease 

of reference, this letter of authorization will use the 

term ‘‘doxycycline hyclate tablet emergency kit(s)’’ 

to refer to both types of kits, unless otherwise 

specified. When referring to the kits separately, this 

letter will use the term ‘‘household doxycycline 

hyclate tablet emergency kit’’ to refer to the HAK 

and the term ‘‘individual doxycycline hyclate tablet 

emergency kit’’ to refer to the iHAK. 

3The term ‘‘eligible’’ refers to USPS participants 

who have agreed in writing to participate in the 

Postal Module of CRI, have been screened for 

fitness to receive OSHA-required personal 

protective equipment, have (including household 

members) been medically screened for 

contraindications based on completed health 

assessment forms, have (including household 

members) been given a valid prescription, and have 

(including household members) not otherwise been 

determined to be ineligible to receive doxycycline 

hyclate tablet emergency kits. 

4 Your submissions define ‘‘household member’’ 

as ‘‘anyone that considers that address as his or her 

permanent place of residence.’’ 

5Memorandum from Michael Chertoff to Michael 

O. Leavitt, Determination Pursuant to § 564 of the 

Federal Food, Drug, and Cosmetic Act (Sept. 23, 

2008). 

6 Declaration of Emergency Pursuant to Section 

564 of the Federal Food, Drug, and Cosmetic Act, 

21 U.S.C. 360bbb-3(b) (Oct. 1, 2008). 

7The doxycycline hyclate tablet emergency kits 

for eligible USPS participants and their household 

members referenced and authorized in this letter 

fall within the scope of the Secretary of the 

Department of Health and Human Services’ 

declaration. 

8 Doxycycline hyclate tablets are indicated for 

treatment of infections caused by ‘‘Anthrax due to 

Bacillus anthracis, including inhalational anthrax 

(post-exposure): to reduce the incidence or 

progression of disease following exposure to 

aerosolized Bacillus anthracis.’’ This indication 

generally means that drug administration is 

expected to start after a known or suspected 

exposure to aerosolized Bacillus anthracis spores, 

but before clinical symptoms of the disease 

develop. The indication includes presumed 

exposure, since it is often difficult to know whether 

and when exposure has actually occurred. The 

indication also encompasses instances where 

Bacillus anthracis exposure via inhalation is 

expected and will be imminent. In such cases, the 

first few doses of prophylaxis may be taken preexposure, but the remainder of the course would be 

taken post-exposure. The indication is commonly 

referred to as ‘‘post-exposure prophylaxis of 

inhalational anthrax,’’ and this term will be used 

throughout this letter for ease of reference. 

Health and Human Services (HHS). 

Following issuance of FDA’s October 3, 

2008, Authorization letter, on February 

19, 2009, BARDA submitted a request 

on behalf of ASPR, to amend the 

Authorization. In response to BARDA’s 

request, FDA amended the 

Authorization letter and reissued the 

Authorization letter in its entirety on 

February 25, 2009. The Authorization, 

as amended and reissued in its entirety, 

is reprinted in this document. 

DATES: The amended Authorization is 

effective as of February 25, 2009. 

ADDRESSES: Submit written requests for 

single copies of the EUA to the Office 

of Counterterrorism and Emerging 

Threats (HF–29), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

14C–26, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

Authorization may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Boris Lushniak, Office of 

Counterterrorism and Emerging Threats 

(HF–29), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4067. 

SUPPLEMENTARY INFORMATION: 

I. Amendment to the October 3, 2008, 

Authorization for Doxycycline Hyclate 

in Emergency Kits 

On September 23, 2008, under section 

564(b)(1)(A) of the the act (21 U.S.C. 

360bbb-3(b)(1)(A)), as amended by the 

Project BioShield Act of 2004 (Public 

Law 108–276), the Secretary of 

Homeland Security determined that 

there is a significant potential for a 

domestic emergency, involving a 

heightened risk of attack with a 

specified biological, chemical, 

radiological, or nuclear agent or 

agents—in this case, Bacillus anthracis. 

On October 1, 2008, under section 

564(b) of the act, and on the basis of 

such determination, the Secretary of 

HHS, Michael O. Leavitt, declared an 

emergency justifying the authorization 

of the emergency use of doxycycline 

hyclate tablets accompanied by 

emergency use information subject to 

the terms of any authorization issued 

under 21 U.S.C. 360bbb-3(a). Notice of 

the determination of the Secretary of 

Homeland Security and the declaration 

of the Secretary of HHS was published 

in the Federal Register on October 6, 

2008 (73 FR 58242). 

On October 1, 2008, BARDA 

requested an EUA for doxycycline 

hyclate tablet emergency kits for eligible 

USPS participants in CRI and their 

household members. As required under 

section 564(h)(1) of the act, on October 

21, 2008, FDA published in the Federal 

Register notice of the Authorization for 

doxycycline hyclate tablet emergency 

kits for eligible USPS participants in the 

CRI and their household members, 

including an explanation of the reasons 

for its issuance (73 FR 62057, October 

21, 2008). On February 19, 2009, 

BARDA submitted a request on behalf of 

ASPR to amend the Authorization to 

make certain changes to the written 

information authorized to accompany 

the doxycycline hyclate tablets and to 

the roles and responsibilities provided 

for in the Authorization. On February 

25, 2009, in response to BARDA’s 

request, FDA amended the 

Authorization letter and reissued the 

Authorization letter in its entirety. 

II. Electronic Access 

An electronic version of this notice 

and the full text of the Authorization are 

available on the Internet at http:// 

www.regulations.gov. 

III. The Authorization 

After having consulted with the 

National Institutes of Health (NIH) and 

the Centers for Disease Control and 

Prevention (CDC) and having concluded 

that the criteria for issuance of this 

Authorization under section 564(c) of 

the act were met, on October 3, 2008, 

FDA authorized the emergency use of 

doxycycline hyclate tablet emergency 

kits for eligible USPS participants in the 

CRI and their household members. The 

letter of authorization in its entirety, as 

amended on February 25, 2009, follows: 

February 25, 2009 

Robin Robinson, Ph.D. 

Director 

Biomedical Advanced Research and 

Development Authority (BARDA) 

330 Independence Avenue SW 

Room G640 

Washington, DC 20201 

Dear Dr. Robinson: 

This letter is in response to BARDA’s 

October 1, 2008 submission, as amended,1

requesting that the Food and Drug 

Administration (FDA) issue an Emergency 

Use Authorization (EUA) for the pre-event 

provision and potential use of doxycycline 

hyclate tablet emergency kits2 for 

inhalational anthrax, pursuant to section 564 

of the Federal Food, Drug, and Cosmetic Act 

(the Act). Your request is specifically for 

eligible3 United States Postal Service (USPS) 

participants in the Cities Readiness Initiative 

(CRI) (hereinafter USPS participants) and 

their household members.4

On September 23, 2008, pursuant to 

section 564(b)(1)(A) of the Act, 21 U.S.C. 

§ 360bbb–3(b)(1)(A), the Secretary of the 

Department of Homeland Security 

determined that there is a significant 

potential for a domestic emergency, 

involving a heightened risk of attack with a 

specified biological, chemical, radiological, 

or nuclear agent or agents--in this case, 

Bacillus anthracis.5 On October 1, 2008, 

pursuant to section 564(b) of the Act, and on 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30579 

9We note that the full course of doxycycline 

hyclate tablets for adults for the post-exposure 

prophylaxis of inhalational anthrax is 100 mg twice 

daily for 60 days. The corresponding oral dosing 

regimen for children under 100 pounds is 1 mg per 

pound of body weight twice daily for 60 days. 

10The Act uses the terms ‘‘diagnosing, treating, or 

preventing’’ in Section 564(c)(2)(A). Post-exposure 

prophylaxis is encompassed by these statutory 

terms. 

11No other criteria of issuance have been 

prescribed by regulation under section 564(c)(4) of 

the Act. 

the basis of such determination, the Secretary 

of the Department of Health and Human 

Services declared an emergency justifying the 

authorization of the emergency use of 

doxycycline hyclate tablets accompanied by 

emergency use information subject to the 

terms of any authorization issued under 21 

U.S.C. § 360bbb-3(a).6,7 Having consulted 

with the National Institutes of Health (NIH) 

and the Centers for Disease Control and 

Prevention (CDC), and having concluded that 

the criteria for issuance of this authorization 

under section 564(c) of the Act are met, I am 

authorizing the emergency use of 

doxycycline hyclate tablet emergency kits for 

the post-exposure prophylaxis of inhalational 

anthrax for eligible USPS participants and 

their household members,8 subject to the 

terms of this authorization. 

The remainder of this letter is organized 

into four sections: Background, Criteria for 

Issuance of Authorization, Scope of 

Authorization, Conditions of Authorization, 

and Duration of Authorization. 

I. Background 

CRI involves 72 major metropolitan areas 

and all 50 states. The primary goal of CRI is 

to develop the ability to provide mass 

prophylaxis to 100% of the identified 

population within 48 hours of notification to 

do so. 

On February 18, 2004, the Secretary of the 

Department of Health and Human Services 

(HHS), the Secretary of the Department of 

Homeland Security (DHS), and the 

Postmaster General signed a Memorandum of 

Agreement to explore how the resources of 

the USPS could be made available to help 

deliver oral antibiotics in response to a 

biological terrorism incident. Subsequently, 

HHS launched CRI and asked the USPS to 

participate in what has been referred to as the 

CRI Postal Module (or Postal Plan). The 

Postal Module involves the delivery of 

antibiotics to residential households within 

pre-determined zip codes by USPS 

participants where there may be an 

intentional release of Bacillus anthracis in 

their geographic area. The CRI Postal Module 

could be activated and executed while the 

municipality is establishing its points-ofdispensing (POD) network for the remainder 

of the emergency response which, in the case 

of a wide-area anthrax event, could continue 

for 1-2 months. The postal carriers’ role is 

voluntary because emergency response is 

neither part of the basic mission of USPS nor 

a provision of the contracts between USPS 

and the unions representing the carriers. 

USPS has made its participation in the CRI 

Postal Module contingent on the pre-event 

provision of prescription antibiotic 

countermeasures to USPS participants and 

their household members. 

Your request relates to a potential EUA for 

the pre-event provision and potential use of 

doxycycline hyclate tablets (100 mg) in the 

form of emergency kit(s) for eligible USPS 

participants and their household members. 

Although doxycycline hyclate tablets are 

approved for the post-exposure prophylaxis 

of inhalational anthrax, the emergency kits 

you describe in your submissions would 

require an EUA because they would include 

certain written information that is not 

currently part of the approved new drug 

applications (NDAs) or abbreviated new drug 

applications (ANDAs) for doxycycline 

hyclate tablets (100 mg). Specifically, you 

indicated that the following pieces of written 

information would accompany the 

doxycycline hyclate tablets: 

• Fact Sheet for Recipients 

• For the household doxycycline hyclate 

tablet emergency kit, home preparation 

instructions for recipients who cannot 

swallow pills (hereinafter home 

preparation instructions) 

• Information placard (unless the bag is 

pre-printed with placard information) 

• MedWatch Form 3500 for the reporting 

of any adverse events associated with the 

doxycycline hyclate tablet emergency kit 

In addition, a Fact Sheet for Health Care 

Providers would be distributed to health care 

providers and authorized dispensers of the 

doxycycline hyclate tablet emergency kits. 

You propose to use doxycycline hyclate 

tablets (100 mg) that were manufactured by 

West-Ward Pharmaceutical Corp., and 

repackaged by PD-Rx Pharmaceuticals into 

unit-of-use bottles containing 20 oral tablets 

each, a 10-day supply.9

The doxycycline hyclate tablet emergency 

kit(s) that are the subject of your request 

would come in two forms. The first, which 

you describe as a Household Antibiotic Kit 

(HAK), would contain a unit-of-use bottle of 

doxycycline hyclate tablets for each eligible 

USPS participant and each eligible 

household member, as well as the Fact Sheet 

for Recipients, home preparation 

instructions, MedWatch Form 3500, and 

information placard (unless bag is preprinted with placard information) described 

above. All of these items would be placed in 

one tamper-evident, clear plastic bag for 

home storage. The second, which you 

describe as an individual Household 

Antibiotic Kit (iHAK), would contain one 

unit-of-use bottle of doxycycline hyclate 

tablets for the eligible USPS participant and 

the Fact Sheet for Recipients, MedWatch 

Form 3500, and information placard (unless 

the bag is pre-printed with placard 

information) described above. All of these 

items would be placed in a separate tamperevident, clear plastic bag for secure storage at 

the USPS participant’s workplace, should the 

USPS participant need to deploy emergently. 

II. Criteria for Issuance of Authorization 

Having considered the September 23, 2008 

determination by the Secretary of the 

Department of Homeland Security that there 

is a significant potential for a domestic 

emergency, involving a heightened risk of 

attack with a biological, chemical, 

radiological, or nuclear agent or agents--in 

this case, Bacillus anthracis, and the October 

1, 2008 declaration of emergency by the 

Secretary of Health and Human Services, and 

having consulted with NIH and CDC, I have 

concluded that the emergency use of 

doxycycline hyclate tablet emergency kits for 

the post-exposure prophylaxis of inhalational 

anthrax for eligible USPS participants and 

their household members meets the criteria 

for issuance of an authorization under 

section 564(c) of the Act, because I have 

concluded that: 

(1) Bacillus anthracis can cause anthrax, a 

serious or life-threatening disease or 

condition; 

(2) based on the totality of scientific 

evidence available to FDA, it is 

reasonable to believe that doxycycline 

hyclate tablet emergency kits may be 

effective for post-exposure prophylaxis 

of inhalational anthrax,10 and that the 

known and potential benefits of 

doxycycline hyclate tablet emergency 

kits, when used for the post-exposure 

prophylaxis of inhalational anthrax in 

the specified population, outweigh the 

known and potential risks of the 

product; and 

(3) there is no adequate, approved, and 

available alternative to doxycycline 

hyclate tablet emergency kits for the 

post-exposure prophylaxis of 

inhalational anthrax.11

Specifically, I have concluded, pursuant to 

section 564(c)(1) of the Act, that Bacillus 

anthracis can cause inhalational anthrax, 

which is a serious or life-threatening disease 

or condition. The fatality rate for inhalational 

anthrax in the United States is estimated to 

be approximately 45 percent to 90 percent. 

From 1900 to October 2001, there were 18 

identified cases of inhalational anthrax in the 

United States, the latest of which was 

reported in 1976, with an 89 percent (16/18) 

mortality rate. Most of these exposures 

occurred in industrial settings, i.e., textile 

mills. From October 4, 2001, to December 5, 

2001, a total of 11 cases of inhalational 

anthrax linked to intentional dissemination 

of Bacillus anthracis spores were identified 

in the United States. Five of these cases were 

fatal. These fatalities occurred despite 

aggressive medical care, including treatment 

with antimicrobial drugs. 

I have also concluded that, based on the 

totality of the scientific evidence available to 

FDA, including data supporting the safe and 

effective use of doxycycline hyclate tablets 

(100 mg) for the post-exposure prophylaxis of 

inhalational anthrax, the results of CDC’s 

home MedKit study, and information 

associated with the development of the home 

preparation instructions, it is reasonable to 

believe that doxycycline hyclate tablet 

emergency kits may be effective for the postexposure prophylaxis of inhalational anthrax 

pursuant to section 564(c)(2)(A) of the Act. 

The above conclusion is largely based on 

the fact that FDA has previously approved a 

number of NDAs and ANDAs for doxycycline 

hyclate tablets for the treatment and postexposure prophylaxis of inhalational anthrax, 

as summarized below. 

In November 2001, as part of a public 

health response to the use of anthrax spores 

30580 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

12See 66 Fed. Reg. 55679 (Nov. 2, 2001); Docket 

01N-0494. 

13 Id. The Federal Register notice further 

requested that applicants for these products submit 

labeling supplements to update their package 

inserts with this information. 

14 In this study, participants who were allergic to 

doxycycline or for whom doxycycline was 

otherwise contraindicated received ciprofloxacin. 

as a bioterrorism agent, the Agency published 

a notice in the Federal Register that clarified 

the dosing recommendations for, among 

others, doxycycline hyclate products, in the 

management of patients with inhalational 

anthrax who had been exposed to spores of 

Bacillus anthracis, but who did not manifest 

clinical disease.12 In that notice, FDA 

announced that it had determined that the 

language in the labeling of certain drug 

products, including those containing 

doxycycline hyclate, is intended to, and 

does, cover all forms of anthrax, including 

inhalational anthrax (post-exposure): to 

reduce the incidence or progression of 

disease exposure to aerosolized B. anthracis. 

FDA also announced that the appropriate 

dosing regimen for adults is 100 mg of 

doxycycline, taken orally twice daily for 60 

days; and the corresponding oral dosing 

regimen for children under 100 pounds is 1 

mg per pound (1 mg/lb) of body weight (2.2 

mg/kilogram (kg)), given twice daily for 60 

days.13 FDA based these conclusions on the 

following: 

• Effectiveness was supported by minimal 

inhibitory concentration (MIC) data for 

the tetracycline class and Bacillus 

anthracis, pharmacokinetic data, data 

from the Sverdlovsk incident, and the 

outcome data from a study of 

inhalational exposure to Bacillus 

anthracis in rhesus monkeys. 

• With respect to safety, FDA noted that 

doxycycline drug products have been 

used for over 30 years and the literature 

on the products is voluminous. FDA 

previously reviewed the literature 

dealing with the long-term 

administration of doxycycline for 

treatment of diseases other than anthrax. 

Several articles reported the results of 

studies involving the administration of 

doxycycline in amounts comparable to 

the recommended doses. They also 

involved administration of doxycycline 

for 60 days and periods approaching and 

exceeding 60 days. FDA also reviewed 

data from the Adverse Event Reporting 

System (AERS). Analysis of these articles 

and data indicated no pattern of 

unlabeled adverse events associated with 

the long-term use of doxycycline. 

• FDA also noted that doxycycline and 

other members of the tetracycline class 

of antibiotics are not generally indicated 

for the treatment of any patients under 

the age of 8 years. Tetracyclines are 

known to be associated with teeth 

discoloration and enamel hypoplasia in 

children and delays in bone 

development in premature infants after 

prolonged use. FDA balanced the nature 

of the effect on teeth and the fact that 

this delay in bone development is 

apparently reversible against the 

lethality of inhalational anthrax, and 

concluded that doxycycline drug 

products can be labeled with a pediatric 

dosing regimen for inhalational anthrax 

(post-exposure). 

As noted above, FDA has approved, under 

section 505(j) of the Act, a number of 

abbreviated new drug applications (ANDAs), 

including West-Ward’s ANDA (#65-095) for 

doxycycline hyclate tablets (100 mg) for 

treatment and post-exposure prophylaxis of 

inhalational anthrax on July 2, 2003. WestWard’s doxycycline hyclate tablets (100 mg), 

which have been repackaged and re-labeled 

by PD-Rx Pharmaceuticals, are the subject of 

this emergency use authorization. This 

product is the same as the reference listed 

drug, Vibra-Tabs (doxycycline hyclate 

tablets, 100 mg; NDA #50-333), within the 

meaning of section 505(j) of the Act. 

I have also considered CDC’s home MedKit 

study and information associated with the 

development of the home preparation 

instructions as part of the totality of the 

scientific evidence available to FDA, and 

have determined that this information helps 

to support the conclusion that it is reasonable 

to believe that doxycycline hyclate tablet 

emergency kits may be effective for postexposure prophylaxis of inhalational anthrax, 

as summarized below. 

The CDC study evaluated the ability of 

study participants to receive what was 

referred to as a MedKit -- doxycycline14 with 

certain written information, including 

emergency use instructions and home 

preparation instructions similar to those 

being authorized here. A convenience sample 

of 4,250 St. Louis area households, divided 

among three cohorts, was enrolled in the 

study after medical screening and informed 

consent. The primary outcomes for this 

evaluation were to determine the extent to 

which participants would follow instructions 

for appropriately keeping the MedKits intact 

and reserving them for emergency use until 

directed by a local government official. 

Although this study had a number of 

limitations as explained below, 

approximately 97% of all study respondents 

returned the MedKits upon completion of the 

study. 

Finally, FDA considered information 

associated with the development of the home 

preparation instructions for doxycycline 

hyclate tablets. FDA had previously 

developed home preparation instructions and 

these instructions were tested by the Chicago 

Department of Public Health, which provided 

its results to FDA. The Agency revised the 

home preparation instructions based on these 

findings and performed additional laboratory 

tests and limited palatability testing. FDA 

also worked with CDC to improve the 

readability of the instructions. 

Although FDA has approved a number of 

NDAs and ANDAs for doxycycline hyclate 

tablets (100 mg) for the treatment and postexposure prophylaxis of inhalational anthrax, 

these products are not approved with 

emergency use instructions and home 

preparation instructions. The amount and 

nature of the scientific evidence regarding 

the ability to use emergency use instructions 

and home preparation instructions is more 

limited than the scientific evidence 

supporting the approval of doxycycline 

hyclate tablets for the post-exposure 

prophylaxis of inhalational anthrax. 

However, taking into consideration the 

potentially fatal nature of anthrax disease, 

the CDC home MedKit study and the 

information associated with the development 

of the home preparation instructions also 

helps to support a conclusion that it is 

reasonable to believe that doxycycline 

hyclate tablet emergency kits may be 

effective for the post-exposure prophylaxis of 

inhalational anthrax. Accordingly, based on 

the totality of the scientific evidence 

available to FDA, it is reasonable to believe 

that doxycycline hyclate tablet emergency 

kits may be effective for the post-exposure 

prophylaxis of inhalational anthrax. 

I have also concluded, pursuant to section 

564(c)(2)(B) of the Act, that it is reasonable 

to believe that the known and potential 

benefits of doxycycline hyclate tablet 

emergency kits outweigh the known and 

potential risks of the product for USPS 

participants and their household members. 

The available scientific evidence that 

supports this conclusion is summarized 

below. 

We have already concluded, as evidenced 

by the previous NDA and ANDA approvals 

discussed above, that the known and 

potential benefits of the approved 

doxycycline hyclate tablets (100 mg) for postexposure prophylaxis of inhalational anthrax 

outweigh the known and potential risks of 

the product. Under this EUA, doxycycline 

hyclate tablets will be packaged with 

additional written information (including 

emergency use instructions and home 

preparation instructions) that has not been 

approved by FDA as part of a new drug 

application. CDC’s home MedKit study and 

the process by which home preparation 

instructions were developed, as discussed 

above, help to further inform the requisite 

risk-benefit analysis under section 

564(c)(2)(B). 

The CDC home MedKit study was 

somewhat limited in its ability to address 

certain questions about home storage and use 

since the participants were not required to 

follow any directions for preparation or use 

of doxycycline hyclate tablets in an actual 

emergency. The effect of the actual storage 

conditions on the stored drug product was 

not tested and the instructions for storage did 

not provide the temperature conditions for 

storage on the outside of the bag. Despite the 

limitations of the CDC home MedKit study, 

it is important to note that approximately 

97% of all study respondents returned the 

MedKits upon completion of the study. 

As described above, the development of 

the home preparation instructions has been 

informed by limited testing and input from 

CDC. However, the current version of the 

home preparation instructions has not been 

subjected to formal independent testing 

procedures for an assessment of an 

individual’s understanding or his/her ability 

to follow the directions. 

Because of the limitations of the CDC study 

and the lack of formal independent testing on 

the home preparation instructions, FDA 

cannot conclude without further testing and 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30581 

15The terms of this letter of authorization, 

including its scope and conditions, are integral to 

the conclusions regarding the known and potential 

risks and benefits of the emergency use of this 

product in eligible USPS participants and their 

household members. 

16See footnote 8. 

17See footnote 3. 

18The emergency use of unapproved, unlicensed, 

or uncleared PPE or the unapproved use of 

approved, licensed, or cleared PPE is not authorized 

as part of this EUA. 

19The term ‘‘repackaged and relabeled’’ will be 

used to refer to the activity of putting unit-of-use 

bottles into clear, tamper-evident bags with the 

addition of certain written information. 

information that the emergency use 

instructions and home preparation 

instructions pose no additional risks to 

eligible USPS participants and their 

household members. Inappropriate use and 

the development of doxycycline resistant 

microorganisms could be a potential issue if 

a considerable number of eligible USPS 

participants take the product for an 

unintended purpose. 

The known and potential risks of eligible 

USPS participants and their household 

members not being able to store, prepare, and 

use doxycycline hyclate tablets in accordance 

with the emergency use instructions and 

home preparation instructions, and of 

experiencing adverse reactions, is 

outweighed by the known and potential 

benefits of using doxycycline hyclate tablets 

as a safe and effective treatment against an 

otherwise potentially fatal aerosolized 

anthrax attack. For the foregoing reasons, it 

is reasonable to believe that the known and 

potential benefits of the doxycycline hyclate 

tablet emergency kits (including emergency 

instructions and home preparation 

instructions as authorized) for the postexposure prophylaxis of inhalational anthrax 

in the specified population outweigh the 

known and potential risks of the product 

under the terms of this letter of 

authorization.15

I have also concluded, pursuant to section 

564(c)(3) of the Act, that there is no adequate, 

approved, and available alternative to the 

doxycycline hyclate tablet emergency kits for 

post-exposure prophylaxis of inhalational 

anthrax in the specified population. 

Although doxycycline hyclate is approved 

for treatment and post-exposure prophylaxis 

of inhalational anthrax, the emergency use 

instructions and home preparation 

instructions included here as part of the 

doxycycline hyclate tablet emergency kits are 

not approved by FDA. 

Other products approved for treatment and 

post-exposure prophylaxis of inhalational 

anthrax include penicillin G procaine, 

ciprofloxacin, and levofloxacin. However, 

none of these products is approved with 

emergency use instructions. In addition, 

penicillin G procaine is administered by 

injection and fluoroquinolones (ciprofloxacin 

and levofloxacin) have additional significant 

adverse events reported following their use, 

including adverse tendon effects and rupture, 

peripheral neuropathy, and central nervous 

system disorders. 

Further, Biothrax (Anthrax Vaccine 

Adsorbed) is indicated for the active 

immunization against Bacillus anthracis of 

individuals between 18 and 65 years of age 

who come in contact with animal products 

such as hides, hair or bones that come from 

anthrax endemic areas, and that may be 

contaminated with Bacillus anthracis spores. 

This product is not considered an ‘‘adequate, 

approved, and available’’ alternative for 

several reasons including: (1) the license for 

Biothrax does not extend to post exposure 

use; (2) the immunization consists of three 

subcutaneous injections given 2 weeks apart 

followed by three additional subcutaneous 

injections given at 6, 12 and 18 months; and 

(3) following the initial injections, time is 

needed to develop the antibodies. Therefore, 

I have concluded that there is no adequate, 

approved, and available alternative to 

doxycycline hyclate tablet emergency kits for 

the post-exposure prophylaxis of inhalational 

anthrax for the specified population. 

III. Scope of Authorization 

Pursuant to section 564(d)(1) of the Act, 

this authorization is limited to the use of 

doxycycline hyclate tablet emergency kits for 

the post-exposure prophylaxis of inhalational 

anthrax16 for eligible17 USPS participants in 

the Postal Module of CRI and their household 

members. 

The doxycycline hyclate tablets authorized 

under this EUA were manufactured by WestWard Pharmaceutical Corp. and have been 

repackaged into unit-of-use bottles 

containing 20 tablets (a 10-day supply) by 

PD-Rx Pharmaceuticals, consistent with 

current Good Manufacturing Practice (CGMP) 

and the Draft Guidance entitled ‘‘Expiration 

Dating of Unit-Dose Repackaged Drugs; 

Compliance Policy Guide.’’ The product has 

been stored under conditions consistent with 

the manufacturer’s labeled storage conditions 

and CGMP and is within its labeled 

expiration date. Once doxycycline hyclate 

tablets covered by this EUA have passed their 

expiration date, they are outside the scope of 

this EUA. 

ASPR will determine whether to initiate 

distribution of product under this EUA to 

particular CRI locations based on: 

(a) whether the municipality has submitted a 

Strategic Security Plan acceptable to USPS 

and ASPR; 

(b) whether the municipality, in 

collaboration with pertinent State public 

health officials, local law enforcement 

agencies, USPS, ASPR, and other 

appropriate entities, has developed a 

mutually acceptable set of policies and 

procedures for recruiting USPS 

participants, screening them for fitness to 

receive doxycycline hyclate tablets, 

providing the doxycycline hyclate tablet 

emergency kits to eligible USPS 

participants and their household members, 

and maintaining the readiness of the 

participant force. Policies and procedures 

must also include screening for fitness to 

receive OSHA-required personal protective 

equipment (PPE) (i.e., N95 masks) and 

provision of PPE to eligible USPS 

participants;18

(c) whether ASPR has determined that it has 

sufficient funds to cover the costs of CRI 

Postal Module implementation in that 

location. 

After the distribution decision has been 

made by ASPR and conveyed to FDA, the 

unit-of-use bottles will be delivered to secure 

site(s), where the participating public health 

authority(ies) will assume control over them. 

Under this EUA, the unit-of-use bottles will 

be repackaged and relabeled19 into 

doxycycline hyclate tablet emergency kits by 

licensed health care providers under the 

auspices of the participating public health 

authority(ies). 

I have concluded, pursuant to section 

564(d)(2) of the Act, that it is reasonable to 

believe that the known and potential benefits 

of the doxycycline hyclate tablet emergency 

kits, when used for the post-exposure 

prophylaxis of inhalational anthrax, 

outweigh the known and potential risks of 

the product for the population described 

above. 

I have concluded, pursuant to section 

564(d)(3) of the Act, based on the totality of 

scientific evidence available to FDA, that it 

is reasonable to believe that the doxycycline 

hyclate tablet emergency kits may be 

effective for the post-exposure prophylaxis of 

inhalational anthrax pursuant to section 

564(c)(2)(A) of the Act. FDA has reviewed the 

scientific information available, including 

the information described in Section II above, 

and concludes that the doxycycline hyclate 

tablet emergency kits, when used for the 

post-exposure prophylaxis of inhalational 

anthrax in the specified population, meet the 

criteria set forth in section 564(c) of the Act 

concerning safety and potential effectiveness. 

The pre-event distribution and use of 

doxycycline hyclate tablet emergency kits 

under this EUA must conform to and may not 

exceed the terms of this letter of 

authorization, including the scope and the 

conditions of authorization set forth below. 

Subject to the terms of this EUA and under 

the circumstances set forth in the Secretary 

of Homeland Security’s determination under 

section 564(b)(1)(A) described above and the 

Secretary of HHS’s corresponding declaration 

under section 564(b)(1), doxycycline hyclate 

tablet emergency kits are authorized for the 

post-exposure prophylaxis of inhalational 

anthrax for eligible USPS participants and 

their household members. 

This EUA will cease to be effective when 

the declaration of emergency is terminated 

under section 564(b)(2) of the Act or when 

the EUA is revoked under section 564(g) of 

the Act. When the EUA ceases to be effective, 

doxycycline hyclate tablet emergency kits 

will no longer be authorized for emergency 

use under this EUA, and doxycycline hyclate 

tablet emergency kits that have been 

distributed under this EUA must be collected 

as described in this letter of authorization. 

IV. Conditions of Authorization 

Pursuant to section 564 of the Act, I am 

establishing the following conditions on this 

authorization: 

A. BARDA will provide to the participating 

public health authority(ies) the written 

materials included in BARDA’s October 3, 

2008 submission, as amended on February 

19, 2009, and authorized under this EUA. 

B. The participating public health 

authority(ies) will conduct an educational 

and information program under appropriate 

30582 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

20USPS postal carriers are not eligible to receive 

a doxycycline hyclate tablet emergency kit if they 

have not passed their N95 mask fit test. See Section 

III, Scope of Authorization, above. 

conditions designed to ensure that health 

care providers or other authorized dispensers 

(hereinafter health care providers) 

distributing doxycycline hyclate tablet 

emergency kits are informed: 

(1) that FDA has authorized the emergency 

use of doxycycline hyclate tablet 

emergency kits for the post-exposure 

prophylaxis of inhalational anthrax for 

eligible USPS participants and their 

household members; 

(2) of the significant known and potential 

benefits and risks of the emergency use 

of doxycycline hyclate tablet emergency 

kits, and of the extent to which such 

benefits and risks are unknown for 

eligible USPS participants and their 

household members; and 

(3) of the alternatives to doxycycline 

hyclate tablet emergency kits for eligible 

USPS participants and their household 

members, and of their benefits and risks. 

With respect to condition (2) above, 

relating to provision of the significant known 

and potential benefits and risks of the 

emergency use of doxycycline hyclate tablet 

emergency kits, the participating public 

health authority(ies) will ensure that the 

manufacturer’s package insert is provided to 

all health care providers who distribute 

doxycycline hyclate tablet emergency kits to 

eligible USPS participants and their 

household members. With respect to 

conditions (1) - (3), the participating public 

health authority(ies) will ensure that health 

care providers are provided with the 

authorized Fact Sheet for Health Care 

Providers. Any revision to the authorized 

Fact Sheet for Health Care Providers is 

subject to FDA’s prior approval. The 

participating public health authority(ies) will 

also ensure that all such health care 

providers are provided with the same 

information as that provided to eligible 

recipients described immediately below. 

C. The participating public health 

authority(ies) will conduct an educational 

and information program under appropriate 

conditions designed to ensure that 

individuals to whom doxycycline hyclate 

tablet emergency kits are distributed are 

informed: 

(1) that FDA has authorized the emergency 

use of doxycycline hyclate tablet 

emergency kits for the post-exposure 

prophylaxis of inhalational anthrax for 

eligible USPS participants and their 

household members; 

(2) of the significant known and potential 

benefits and risks of the emergency use 

of doxycycline hyclate tablet emergency 

kits for eligible USPS participants and 

their household members, and of the 

extent to which such benefits and risks 

are unknown; and 

(3) of the option to accept or refuse 

administration of doxycycline hyclate 

tablet emergency kits, of the 

consequences, if any, of refusing 

administration of the product, and of the 

alternatives to the product that are 

available, and of their benefits and risks. 

As a condition of this authorization, the 

participating public health authority(ies) will 

ensure that, prior to distribution of 

doxycycline hyclate tablet emergency kits, 

the authorized information that meets the 

requirements set forth above is provided to 

each eligible recipient (i.e., in the case of the 

household doxycycline hyclate emergency 

kit, the Fact Sheet for Recipients, home 

preparation instructions, and information 

placard (or bag pre-printed with placard 

information); in the case of the individual 

doxycycline hyclate emergency kit, the Fact 

Sheet for Recipients, and information placard 

(or bag pre-printed with placard 

information)). Any revision to the authorized 

information for potential recipients is subject 

to FDA’s prior approval. 

D. The participating public health 

authority(ies) will distribute doxycycline 

hyclate tablet emergency kits to eligible 

recipients through health care providers who 

are qualified and licensed under applicable 

state law to dispense prescription drugs. The 

health care providers will distribute 

doxycycline hyclate tablet emergency kits 

under conditions that assure that otherwise 

eligible20 recipients are screened for medical 

eligibility (including contraindications) and 

are issued prescriptions for the doxycycline 

hyclate tablet emergency kit. Such conditions 

shall include exclusion of a USPS participant 

if: 

• No medical history and Health 

Assessment Form is available for the 

USPS participant or any member of their 

household; or 

• Doxycycline hyclate is contraindicated 

for the USPS participant. 

The participating public health 

authority(ies) must ensure documentation of 

eligibility or ineligibility to receive 

doxycycline hyclate tablet emergency kits. If 

doxycycline hyclate tablets are 

contraindicated for any of the USPS 

participant’s household members, the USPS 

participant can still receive the doxycycline 

hyclate tablet emergency kit if s/he consents 

in writing to accept an incomplete kit and 

acknowledges that the household member(s) 

will have the same dependence on whatever 

community-based mass prophylaxis is 

available to the general public in an 

emergency. 

USPS will be responsible for providing 

copies of the authorized Health Assessment 

Form to potential USPS participants. If they 

elect to apply for participation, potential 

USPS participants and their household 

members should complete Health 

Assessment Forms and mail them to the 

participating public health authority(ies) at 

the address provided. Qualified health care 

providers, under the auspices of the 

participating public health authority(ies), 

will be responsible for reviewing the 

completed Health Assessment Forms to 

determine whether potential recipients are 

eligible to receive doxycycline hyclate tablet 

emergency kits prior to dispensing such kits 

to eligible USPS recipients . Any revision of 

the authorized Health Assessment Form is 

subject to FDA’s prior approval. A health 

care provider will review with each USPS 

participant his/her Health Assessment Form 

and the Health Assessment Form 

corresponding to each family member and 

will comply with applicable state prescribing 

laws before authorizing the filling of one 

unit-of-use bottle for each eligible USPS 

participant and household member. See 

Section D below for requirements regarding 

repackaging and relabeling of doxycycline 

hyclate tablet emergency kits prior to 

dispensing to eligible recipients. 

E. Doxycycline hyclate tablet emergency 

kits must be manufactured, (re)packaged, 

(re)labeled, and held according to applicable 

good manufacturing practice requirements, 

except that with respect to the doxycycline 

hyclate tablet emergency kits that will be 

repackaged and relabeled by participating 

local public health authorities using the 

doxycycline unit-of-use bottles manufactured 

by West-Ward Pharmaceutical Corp. and 

repackaged by PD-Rx Pharmaceuticals 

described in this EUA, the Secretary waives 

good manufacturing practice requirements 

applicable to the repackaging and relabeling 

of such kits, subject to the following 

requirements 

• The participating public health 

authority(ies) will be responsible for 

repackaging and relabeling doxycycline 

hyclate unit-of-use bottles into 

doxycycline hyclate tablet emergency 

kits through health care providers 

qualified and licensed under state law to 

dispense prescription drugs. 

• The packaging and relabeling described 

below should be performed in a 

controlled environment such that there 

is adequate space, lighting, and freedom 

from debris and from other drug 

products to prevent mix-ups or crosscontamination. 

• A health care provider who initially 

assembles the doxycycline hyclate tablet 

emergency kits will do the following: 

Æ The health care provider will determine 

the number of authorized individuals in 

a household eligible to receive the 

product using the completed Health 

Assessment Form. The health care 

provider will document the prescription 

number, lot number, and expiration date 

of doxycycline hyclate for each 

authorized individual. 

Æ The health care provider will record all 

prescription numbers for the household 

on the Healthcare Provider Quality 

Checklist. 

Æ The health care provider will be 

responsible for maintaining an 

inventory/drug accountability record. At 

a minimum, this record will contain a 

running total/balance, the date filled, 

household name, and number of unit-ofuse bottles dispensed to a household. 

The prescription number, lot number, 

and expiration date of the doxycycline 

hyclate tablets for each authorized 

individual will also be recorded. 

Æ For the household doxycycline hyclate 

tablet emergency kit, the health care 

provider will place the correct number of 

unit-of-use bottles of doxycycline hyclate 

(corresponding to the authorized USPS 

participant and each authorized 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 30583 

household member) in one clear, tamperevident plastic bag. Each unit-of-use 

bottle will be labeled with the 

appropriate authorized individual’s 

name. 

Æ For an individual doxycycline hyclate 

tablet emergency kit, the health care 

provider will place one unit-of-use bottle 

of doxycycline hyclate tablets in a 

separate clear, tamper-evident plastic bag 

for the authorized USPS participant for 

secure storage by the USPS at work. The 

unit-of-use bottle will be labeled with 

the authorized USPS participant’s name. 

Æ For the household doxycycline hyclate 

tablet emergency kit, the health care 

provider will place the Fact Sheet for 

Recipients, home preparation 

instructions, and MedWatch Form 3500 

inside and in the outer pocket of the 

clear, tamper-evident plastic bag; and, if 

the bag is not pre-printed with placard 

information, the health care provider 

will place the information placard inside 

the bag facing out so the wording is 

plainly visible. 

Æ For the individual doxycycline hyclate 

tablet emergency kit, the health care 

provider will place the Fact Sheet for 

Recipients and MedWatch Form 3500 

Form inside and in the outer pocket of 

the clear, tamper-evident plastic bag; 

and, if the bag is not pre-printed with 

placard information, the health care 

provider will place the information 

placard inside the bag facing out so the 

wording is plainly visible. 

Æ The health care provider will complete 

the first page of the Healthcare Provider 

Quality Checklist, including signature 

and date. 

Æ The health care provider will not seal 

the bag, and will give it to the identified 

health care provider to check the 

contents of the bags as described below. 

• Before dispensing, a different health care 

provider will check each doxycycline 

hyclate tablet emergency kit that has 

been assembled as follows: 

Æ Review and verify Health Assessment 

Forms for eligibility of USPS participant 

and each household member to receive 

the doxycycline hyclate tablet emergency 

kit. 

Æ Verify that each unit-of-use bottle is 

labeled with the authorized individual’s 

name. 

Æ Verify the prescription number, lot 

number, and expiration date of the 

doxycycline hyclate tablets for each 

authorized individual on the Health 

Assessment Forms. 

Æ Verify prescription numbers for each 

authorized individual on the Healthcare 

Provider Quality Checklist. 

Æ For the household doxycycline hyclate 

tablet emergency kit, verify that the 

correct number of unit-of-use bottles of 

doxycycline hyclate tablets have been 

placed in the tamper-evident bag for that 

household based on the number of 

household members eligible. For the 

individual doxycycline hyclate tablet 

emergency kit, verify that the correct 

unit-of-use bottle of doxycycline hyclate 

tablets has been placed in the tamperevident bag for the USPS participant for 

secure storage by USPS at work. 

Æ Verify that the appropriate written 

information is inside the tamper-evident 

bags. 

Æ Verify that the appropriate written 

information is in the outer pocket of the 

tamper-evident bags. 

Æ If the information placard is not preprinted on the outside of the tamperevident bags, verify that the information 

placard is inside the tamper-evident bags 

and plainly visible. 

Æ Complete the second page of the 

Healthcare Provider Quality Checklist, 

including signature and date. 

Æ Seal the bags. 

Æ Attach the Healthcare Provider Quality 

Checklist to the Health Assessment 

Forms for the household. 

Æ The doxycycline hyclate tablet 

emergency kits may then be dispensed to 

the USPS participant along with review 

of the instructions and information. 

The authorized Healthcare Provider 

Quality Checklist and placard information 

will be used. Any revision of the authorized 

Healthcare Provider Quality Checklist or 

placard information is subject to FDA’s prior 

approval. 

F. ASPR will record the amount of unit-ofuse bottles of doxycycline hyclate tablets 

(including lot numbers) shipped under this 

EUA to the participating public health 

authority(ies) for use by eligible USPS 

participants and their households. Such 

records will be made available to FDA for 

inspection upon request. However, the the 

participating public health authority(ies) 

responsible for distributing the doxycycline 

hyclate tablet emergency kits will prepare, 

maintain, and make available records and 

provide reports as directed by ASPR/FDA. 

G. Once an individual doxycycline hyclate 

tablet emergency kit has been dispensed to 

an eligible USPS participant, USPS will store 

the individual doxycycline hyclate tablet 

emergency kit in a secure location for the 

eligible USPS participant. 

H. ASPR, USPS, and the participating 

public health authority(ies) may only provide 

written materials as included in BARDA’s 

October 3, 2008 submission, as amended on 

February 19, 2009, and authorized under this 

EUA. Any revisions or additional written 

materials to be provided by ASPR, USPS, or 

the participating public health authority(ies) 

are subject to FDA’s prior approval, except 

that USPS may provide additional materials 

for recruitment purposes to the extent that 

those materials are consistent with the 

materials included in BARDA’s October 3, 

2008 submission, as amended on February 

19, 2009, that are authorized under this EUA. 

The participating public health authority(ies) 

may evaluate activities undertaken pursuant 

to this authorization. To ensure consistency 

with this authorization, the participating 

public health authority(ies) must consult 

with FDA before conducting such 

evaluations. 

I. The participating public health 

authority(ies) will conduct an adverse event 

monitoring and reporting program designed 

to ensure that adverse events and medication 

errors associated with the use of the 

doxycycline hyclate tablet emergency kit are 

documented and reported within 15 days to 

MedWatch through www.fda.gov/medwatch, 

by submitting MedWatch Form 3500 in hard 

copy, or by calling 1-800-FDA-1088; and that 

any such report identifies the product as 

‘‘doxycycline hyclate tablet emergency kit’’ 

and includes in the description of the event 

the designation ‘‘USPS-CRI EUA’’ or ‘‘USPSCRI Emergency Use Authorization.’’ As part 

of this program, health care providers will be 

provided copies of MedWatch Form 3500, 

recipients will be instructed to report if they 

take any of the doxycycline hyclate tablets in 

their emergency kit and experience an 

adverse event or medication error, MedWatch 

Form 3500 will be included in each 

doxycycline hyclate tablet emergency kit, 

and recipients will be provided with a tollfree number for contacting a health care 

provider if they experience an adverse event 

or medication error. The participating public 

health authority(ies) will maintain associated 

records until notified by FDA and will make 

such records available to FDA for inspection 

upon request. 

J. The participating public health 

authority(ies) will periodically verify and 

document that any undistributed 

doxycycline hyclate is within its labeled 

expiration date. The participating public 

health authority(ies) will maintain any 

associated records until notified by FDA and 

will make such records available to FDA for 

inspection upon request. Appropriate local 

public health authorities will periodically 

verify and reconcile drug accountability 

records. 

K. USPS will be responsible for providing 

USPS participants every six months with the 

Form entitled ‘‘Questions to Determine 

Status of Your Household Antibiotic Kit 

(HAK)’’ (Kit Status form) to document 

whether (a) they have stored their kits as 

instructed; (b) they are able to locate their 

kits readily; (c) their kits are intact; and (d) 

the doxycycline hyclate in their kits has not 

expired. USPS participants should complete 

these forms and mail them to the 

participating public health authority(ies) at 

the address provided. The participating 

public health authority(ies) will ascertain the 

circumstances surrounding non-compliance 

for USPS participants who (a) report loss of 

a kit; (b) report use of doxycycline hyclate 

from the emergency kit in the absence of 

instructions to do so; or (c) fail to return a 

completed Kit Status Form. Depending on its 

findings, the participating public health 

authority(ies) may disqualify an individual 

from further participation. If the doxycycline 

hyclate emergency kit will expire before the 

next 6-month follow-up, a new doxycycline 

hyclate emergency kit will be prescribed for 

eligible participants in accordance with 

paragraph D and the other terms of this letter. 

In such cases, USPS will be responsible for 

collecting such kits and turning them over to 

the participating public health authority(ies), 

which then will be responsible for 

accounting for them and disposing ofthem as 

instructed by ASPR. The participating public 

health authority(ies) will maintain drug 

accountability records. The participating 

public health authority(ies) will also 

30584 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Notices 

ascertain whether there have been any 

adverse events or medication errors 

associated with the doxycycline hyclate 

tablet emergency kit. If any such adverse 

events or medication errors have not 

previously been reported to FDA as outlined 

in paragraph H, they must be reported within 

15 days to FDA. FDA has authorized ASPR’s 

Form entitled ‘‘Questions to Determine 

Status of Your Household Antibiotic Kit 

(HAK)’’ (Kit Status form). Any revision of the 

Kit Status form is subject to FDA’s prior 

approval. USPS, in conjunction with 

appropriate local public health authorities, 

will be responsible for ensuring that 

completed Kit Status forms are maintained 

until notified by FDA. A report summarizing 

the information collected on Kit Status forms 

under this paragraph will be submitted to 

FDA within 30 days of gathering such 

information. Associated records will be made 

available to FDA for inspection upon request. 

L. USPS will be responsible for collecting 

any expired doxycycline hyclate tablet 

emergency kits and turning them over to the 

participating public health authority(ies). 

The participating public health authority(ies) 

will be responsible for disposing of expired 

doxycycline hyclate tablet emergency kits as 

instructed by ASPR at that time. The 

participating public health authority(ies) will 

ensure that drug accountability records are 

maintained and reconciled. Such records 

shall be made available to FDA for inspection 

upon request. 

M. USPS and the participating public 

health authority(ies) will be responsible for 

ensuring that completed Health Assessment 

Forms, Healthcare Provider Quality 

Checklists, and any other records associated 

with this EUA are maintained until notified 

by FDA. Such records will be made available 

to FDA for inspection upon request. 

N. As a condition of this EUA, all 

advertising and promotional descriptive 

printed matter relating to the use of 

doxycycline hyclate tablet emergency kits 

authorized under this EUA shall be 

consistent with the Fact Sheets, home 

preparation instructions, and placard 

information, as well as the terms set forth in 

this EUA and other requirements set forth in 

the Act and FDA regulations. 

O. Upon termination of the declaration of 

emergency under section 564(b)(2) of the Act 

or upon revocation of this EUA under section 

564(g) of the Act, USPS will be responsible 

for collecting all doxycycline hyclate tablet 

emergency kits and turning them over to the 

participating public health authority(ies). 

The participating public health authority(ies) 

will dispose of doxycycline hyclate 

emergency kits as instructed by ASPR at that 

time. The participating public health 

authority(ies) will ensure that drug 

accountability records are maintained and 

reconciled. Such records will be made 

available to FDA for inspection upon request. 

P. HHS will notify FDA of its decision to 

add a CRI location and its decision to initiate 

distribution of doxycycline hyclate tablet 

emergency kits under this EUA to particular 

CRI locations. 

The emergency use of doxycycline hyclate 

tablet emergency kits as described in this 

letter of authorization must comply with the 

conditions above and all other terms of this 

authorization. 

V. Duration of Authorization 

This EUA will be effective until the 

declaration of emergency is terminated under 

section 564(b)(2) of the Act or the EUA is 

revoked under section 564(g) of the Act. 

Randall W. Lutter, Ph.D. 

Deputy Commissioner for Policy 

Dated: June 17, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–15044 Filed 6–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2896–FN2] 

Medicare and Medicaid Programs; 

Approval of the Joint Commission’s 

Continued Deeming Authority for 

Critical Access Hospitals 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final Notice of Removal of 

Conditional Probationary Status. 

SUMMARY: Based on our review and 

observations, we have determined that 

the Joint Commission’s accreditation 

standards for critical access hospitals 

(CAHs) meet or exceed our 

requirements. Therefore, this final 

notice announces our decision to 

approve without condition the Joint 

Commission’s request for continued 

recognition as a national accreditation 

program for CAHs seeking to participate 

in the Medicare or Medicaid programs. 

DATES: Effective Date: This final notice 

of approval is effective November 21, 

2008 through November 21, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in a Critical Access Hospital 

(CAH) provided certain requirements 

are met. Sections 1820(c)(2)(B) and 

1861(mm) of the Social Security Act 

(the Act) establish distinct criteria for 

facilities seeking designation as a CAH. 

Under this authority, the minimum 

requirements that a CAH must meet to 

participate in Medicare are set forth in 

regulations at 42 CFR part 485, subpart 

F (Conditions of Participation: Critical 

Access Hospitals (CAHs)) which 

determine the basis and scope of CAH 

covered services. Conditions for 

Medicare payment for CAHs are set 

forth at § 413.70. Applicable regulations 

concerning provider agreements are 

located in 42 CFR part 489 (Provider 

Agreements and Supplier Approval) and 

those pertaining to facility survey and 

certification are located in 42 CFR part 

488, subparts A and B. 

In general, we approve a CAH for 

participation in the Medicare program if 

it is participating as a hospital at the 

time it applies for CAH designation, and 

it is in compliance with part 482 

(Conditions of Participation for 

Hospitals) and part 485, subpart F 

(Conditions of Participation: Critical 

Access Hospital (CAHs)). 

For a CAH to enter into a provider 

agreement, a State survey agency must 

certify that the CAH is in compliance 

with the conditions or standards set 

forth in section 1820 of the Act and part 

485 of our regulations. Thereafter, the 

CAH is subject to ongoing review by a 

State survey agency to determine 

whether it continues to meet the 

Medicare requirements. There is, 

however, an alternative to State 

compliance surveys. Accreditation by a 

nationally-recognized accreditation 

program can substitute for ongoing State 

review. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accreditation organization (AO) 

that all applicable Medicare conditions 

are met or exceeded, we may ‘‘deem’’ 

that provider entity as having met the 

requirements. Accreditation by an AO is 

voluntary and is not required for 

Medicare participation. 

A national AO applying for approval 

of deeming authority under part 488, 

subpart A must provide us with 

reasonable assurance that the AO 

requires the accredited provider entities 

to meet requirements that are at least as 

stringent as the Medicare conditions of 

participation. Our regulations 

concerning re-approval of AOs are set 

forth at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require AOs 

to reapply for continued approval of 

deeming authority every 6 years, or 

sooner as we determine. The regulations 

at § 488.8(f)(3)(i) provide CMS the 

authority to grant conditional approval 

of an AO’s deeming authority, with a 

180-day probationary period, if the AO 

has not adopted comparable standards 

during the reapplication process. 

We received a complete application 

from the Joint Commission for 

continued recognition as a national 

accrediting organization for CAHs on 

March 28, 2008. In accordance with the