Federal Register / Vol. 73, No. 185 / Tuesday, September 23, 2008 / Notices 54831 

product, are subject to FDA enforcement action at 

any time. 5For the purposes of this notice, the term 

‘‘commercially used or sold’’ means that the 

product has been used in a business or activity 

involving retail or wholesale marketing and/or sale. 

6 If FDA finds it necessary to take enforcement 

action against a product covered by this notice, the 

agency may take action relating to all of the 

defendant’s other violations of the act at the same 

time. For example, if a firm continues to 

manufacture or market a product covered by this 

notice after the applicable enforcement date has 

passed, to preserve limited agency resources, FDA 

may take enforcement action relating to all of the 

firm’s unapproved drugs that require applications at 

the same time (see, e.g., United States v. Sage 

Pharmaceuticals, 210 F.3d 475, 479–480 (5th Cir. 

2000) (permitting the agency to combine all 

violations of the act in one proceeding, rather than 

taking action against multiple violations of the act 

in ‘‘piecemeal fashion’’)). 

As described in the Marketed 

Unapproved Drugs CPG, the agency 

may, at its discretion, identify a period 

of time during which the agency does 

not intend to initiate an enforcement 

action against a currently marketed 

unapproved drug solely on the ground 

that it lacks an approved application 

under section 505 of the act. With 

respect to unapproved ophthalmic 

balanced salt solution products, the 

agency intends to exercise its 

enforcement discretion for only a 

limited period of time because 

ophthalmic balanced salt solution 

products are drugs with potential safety 

risks and approved ophthalmic 

balanced salt solutions for use in 

surgical procedures of both shorter and 

longer durations have been available 

since 1997. Therefore, the agency 

intends to implement this notice as 

follows. 

For the effective date of this notice, 

see the DATES section of this document. 

FDA intends to take enforcement action 

to enforce section 505(a) of the act 

against any unapproved ophthalmic 

balanced salt solution product that is 

not listed with the agency in full 

compliance with section 510 of the act 

(21 U.S.C. 360) before September 22, 

2008, and is manufactured, shipped, or 

otherwise introduced or delivered for 

introduction into interstate commerce 

by any person on or after September 23, 

2008. FDA also intends to take 

enforcement action to enforce section 

505(a) of the act against any unapproved 

ophthalmic balanced salt solution that 

is listed with FDA in full compliance 

with section 510 of the act but is not 

being commercially used or sold5 in the 

United States on September 22, 2008 

and that is manufactured, shipped, or 

otherwise introduced or delivered for 

introduction into interstate commerce 

by any person on or after September 23, 

2008. 

However, for unapproved ophthalmic 

balanced salt solution products that are 

commercially used or sold in the United 

States, have a National Drug Code (NDC) 

number listed with FDA, and are in full 

compliance with section 510 of the act 

before September 22, 2008 (‘‘currently 

marketed and listed’’), the agency 

intends to exercise its enforcement 

discretion as follows. FDA intends to 

initiate enforcement action against any 

currently marketed and listed 

unapproved ophthalmic balanced salt 

solution product that is manufactured 

on or after November 24, 2008 or that 

is shipped on or after January 21, 2009.6

Further, FDA intends to take 

enforcement action against any person 

who manufactures or ships such 

products after these dates. Any person 

who has submitted or submits an 

application for an ophthalmic balanced 

salt solution product but has not 

received approval must comply with 

this notice. 

The agency, however, does not intend 

to exercise its enforcement discretion as 

outlined previously if the following 

apply: (1) A manufacturer or distributor 

of an unapproved ophthalmic balanced 

salt solution product covered by this 

notice is violating other provisions of 

the act, including but not limited to, 

violations related to FDA’s current good 

manufacturing practices, adverse drug 

event reporting, labeling or misbranding 

requirements or (2) it appears that a 

firm, in response to this notice, 

increases its manufacture or interstate 

shipment of ophthalmic balanced salt 

solution products above its usual 

volume during these periods. 

Nothing in this notice, including 

FDA’s intent to exercise its enforcement 

discretion, alters any person’s liability 

or obligations in any other enforcement 

action, or precludes the agency from 

initiating or proceeding with 

enforcement action in connection with 

any other alleged violation of the act, 

whether or not related to an unapproved 

drug product covered by this notice. 

Similarly, a person who is or becomes 

enjoined from marketing unapproved 

drugs may not resume marketing of 

unapproved ophthalmic balanced salt 

solution products based on FDA’s 

exercise of enforcement discretion that 

is set forth in this notice. 

Drug manufacturers and distributors 

should be aware that the agency is 

exercising its enforcement discretion as 

described previously only in regard to 

ophthalmic balanced salt solution 

products that are marketed under an 

NDC number listed with the agency in 

full compliance with section 510 of the 

act before September 22, 2008. As 

previously stated, unapproved 

ophthalmic balanced salt solution 

products that are currently marketed but 

not listed with the agency on the date 

of this notice must, as of the effective 

date of this notice, have approved 

applications prior to their shipment in 

interstate commerce. Moreover, any 

person or firm that has submitted or 

submits an application but has yet to 

receive approval for such products is 

still responsible for full compliance 

with this notice. 

C. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

NDC number(s), and stating that the 

product(s) has (have) been 

discontinued. The letter should be sent 

to Jennifer Devine (see ADDRESSES). 

Firms should also update the listing of 

their products under section 510(j) of 

the act to reflect discontinuation of 

unapproved ophthalmic balanced salt 

solution products. FDA plans to rely on 

its existing records, including drug 

listing records, or other available 

information when it targets violations 

for enforcement action. 

This notice is issued under the 

Federal Food, Drug, and Cosmetic Act 

(sections 502 and 505 (21 U.S.C. 352)) 

and under authority delegated to the 

Deputy Commissioner for Policy under 

section 1410.10 of the FDA Staff Manual 

Guide. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22305 Filed 9–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0481] 

Topical Drug Products Containing 

Papain; Enforcement Action Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


jlentini on PROD1PC65 with NOTICES
54832 Federal Register / Vol. 73, No. 185 / Tuesday, September 23, 2008 / Notices 

1A ‘‘person’’ includes individuals, partnerships, 

corporations, or associations (21 U.S.C. 321(e)). 

2Lacy, D.F., Armstrong, L.L., Goldman, M.P., 

Lance, L.L., eds., Drug Information Handbook, 

2008–2009; 17th edition. 

3See http://www.foodreference.com/html/ 

fmeatttenterizer.html. 

4 Data in the current system date back to 1969, 

when FDA first implemented an adverse event 

reporting system. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing its 

intention to take enforcement action 

against unapproved topical drug 

products containing papain and 

persons1 who manufacture or cause the 

manufacture of such products or their 

shipment in interstate commerce. 

Topical drug products containing 

papain are marketed, without approved 

applications, to debride necrotic tissue 

and liquefy slough in acute and chronic 

lesions. Potentially serious adverse 

events have been reported with topical 

drug products containing papain. 

Topical drug products containing 

papain are new drugs that require 

approved applications because they are 

not generally recognized as safe and 

effective. Currently no firm has an 

approved application to market a topical 

drug product containing papain. 

Manufacturers who wish to market 

topical drug products containing papain 

must obtain FDA approval of a new 

drug application (NDA) or an 

abbreviated new drug application 

(ANDA). 

DATES: This notice is effective 

September 23, 2008. For information 

about enforcement dates, see 

SUPPLEMENTARY INFORMATION, section 

III.B. 

ADDRESSES: All communications in 

response to this notice should be 

identified with Docket No. FDA–2008– 

N–0481 and directed to the appropriate 

office listed as follows: 

Regarding applications under section 

505(b) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

355(b)): Division of Dermatology and 

Dental Products, Office of New Drugs, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Silver Spring, MD 

20993–0002. 

All other communications: Jennifer 

Devine, Center for Drug Evaluation and 

Research (HFD–310), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51 (rm. 5240), Silver Spring, 

MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Devine, Office of Compliance, 

Division of New Drugs and Labeling 

Compliance, Center for Drug Evaluation 

and Research (HFD–310), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51 (rm. 5240), 

Silver Spring, MD 20993–0002, 301– 

796–3347, e-mail: 

Jennifer.Devine@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Papain is a protein-cleaving enzyme 

derived from papaya fruit (Carica 

papaya) and certain other plants. The 

latex of the papaya plant and its green 

fruits contain two proteolytic enzymes, 

papain and chymopapain. The latter is 

most abundant, but papain is twice as 

potent. The presence and effects of 

proteases in papaya fruit latex have 

been well known since the 1750s, but it 

was not until the 1870s that the 

importance of papaya latex as a source 

of enzymes was recognized. Although 

the exact year is unknown, marketing of 

topical papain drug products in the 

United States began before 1962. 

Topical drug products containing 

papain are used for the debridement of 

necrotic tissue and liquefication of 

slough in acute and chronic lesions, 

such as diabetic ulcers, pressure ulcers, 

varicose ulcers, and miscellaneous 

traumatic infected wounds. These 

products generally combine papain with 

other active ingredients (such as urea, 

chlorophyllin copper complex, and 

copper sodium chlorophyllin), which 

are intended to promote healthy 

granulation, control local inflammation, 

reduce wound odors, and rehydrate 

skin. In addition, papain is marketed in 

oral formulations for a variety of 

indications, including as an aid in 

protein digestion.2 It is also used in the 

food industry as a meat tenderizer.3

Papain-containing drug products in 

topical form historically have been 

marketed without approval, and because 

no firm obtained an application for 

them prior to passage of the Drug 

Amendments of 1962, they were not 

included in the Drug Efficacy Study 

Implementation (DESI) review. 

II. Safety and Efficacy Issues in the Use 

of Topical Papain Drug Products 

Adverse events associated with the 

use of topical papain products reported 

to FDA raise serious safety concerns 

regarding these products. Through 

January 2008,4 FDA has received 37 

reports of adverse events associated 

with topical papain products. In 

addition to several complaints that the 

products were ineffective, the reports 

include cases of potentially lifethreatening hypersensitivity reactions. 

Reactions described include serious 

cases of anaphylaxis and anaphylactic 

shock that started within 15 minutes of 

topical papain use and resulted in 

hospitalizations, including admissions 

to the intensive care unit. Published 

literature also describes incidents of 

hypersensitivity to other papaincontaining products, including meat 

tenderizer, contact lens solution, and 

adhesive removers in the beauty 

industry. Another concern exists 

regarding patients with latex sensitivity. 

Cross-reactivity between latex and 

papaya has been documented in 

medical literature, and one of the cases 

reported to FDA involved anaphylactic 

shock in a patient with a history of 

allergy to latex. It is notable that 

labeling for currently marketed topical 

papain products does not provide any 

warnings regarding hypersensitivity 

reactions and latex cross-reactivity. 

FDA is particularly concerned about 

adverse events associated with the use 

of papain-containing topical drug 

products in light of the dearth of 

published well-controlled studies 

demonstrating the effectiveness of those 

products. Given the absence of the kinds 

of scientific studies routinely conducted 

by sponsors and submitted for agency 

review as part of the FDA approval 

process, it is impossible for the agency 

to assess either the amount of risk 

associated with these products or the 

extent to which their benefits might 

justify their risks, including severe, 

systemic, potentially life-threatening 

hypersensitivity reactions. 

III. Legal Status 

A. Topical Papain Products Are New 

Drugs Requiring Approved Applications 

Based both on the safety 

considerations previously described and 

the absence of published literature 

documenting that topical drugs 

containing papain are safe and effective, 

such drugs are not generally recognized 

as safe and effective under section 

201(p) of the act (21 U.S.C. 321(p)) for 

any indication, including for the 

debridement of necrotic tissue and 

liquefication of slough in acute and 

chronic lesions. Therefore, a topical 

drug product containing papain, alone 

or in combination with other drugs, is 

regarded as a new drug as defined in 

section 201(p) of the act and is subject 

to the requirements of section 505 of the 

act. As set forth in this notice, approval 

of an NDA or an ANDA under section 

505 of the act is required as a condition 

for manufacturing or marketing all 

topical drug products containing 

papain. After the dates identified in this 

notice, FDA intends to take enforcement 

action as described in this notice against 

unapproved topical drug products 

containing papain and persons who 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 185 / Tuesday, September 23, 2008 / Notices 54833 

5The agency’s general approach in dealing with 

these products in an orderly manner is spelled out 

in the Marketed Unapproved Drugs CPG. That CPG, 

however, provides notice that any product that is 

being marketed illegally, and the persons 

responsible for causing the illegal marketing of the 

product, are subject to FDA enforcement action at 

any time. 

6For the purposes of this notice, the term 

‘‘commercially used or sold’’ means that the 

product has been used in a business or activity 

involving retail or wholesale marketing and/or sale. 

7 If FDA finds it necessary to take enforcement 

action against a product covered by this notice, the 

agency may take action relating to all of the 

defendant’s other violations of the act at the same 

time. For example, if a firm continues to 

manufacture or market a product covered by this 

notice after the applicable enforcement date has 

passed, to preserve limited agency resources, FDA 

may take enforcement action relating to all of the 

firm’s unapproved drugs that require applications at 

the same time (see, e.g., United States v. Sage 

Pharmaceuticals, 210 F. 3d 475, 479–480 (5th Cir. 

2000) (permitting the agency to combine all 

violations of the act in one proceeding, rather than 

taking action against multiple violations of the act 

in ‘‘piecemeal fashion’’)). 

cause the manufacture or interstate 

shipment of such products. Any person 

who submits an NDA or an ANDA for 

a topical product containing papain but 

has not received approval must comply 

with this notice. 

This notice does not affect drugs 

containing papain in oral dosage forms, 

which FDA intends to address at a later 

date. 

B. Notice of Enforcement Action 

Although not required to do so by the 

Administrative Procedure Act, the act, 

or any rules issued under its authority, 

or for any other legal reason, FDA is 

providing this notice to persons who are 

marketing unapproved topical drug 

products containing papain that the 

agency intends to take enforcement 

action against such products and those 

who manufacture them or cause them to 

be manufactured or shipped in 

interstate commerce. Manufacturing or 

shipping unapproved topical products 

containing papain can result in 

enforcement action, including seizure, 

injunction, or other judicial or 

administrative proceeding. Consistent 

with policies described in the agency’s 

guidance entitled ‘‘Marketed 

Unapproved Drugs—Compliance Policy 

Guide’’ (the Marketed Unapproved 

Drugs CPG), the agency does not expect 

to issue a warning letter or any other 

further warning to firms prior to taking 

enforcement action relating to 

unapproved papain-containing topical 

drug products. The agency also reminds 

firms and individuals that, as stated in 

the Marketed Unapproved Drugs CPG, 

any unapproved drug marketed without 

a required approved drug application is 

subject to agency enforcement action at 

any time. The issuance of this notice 

does not in any way obligate the agency 

to issue similar notices or any notice in 

the future regarding marketed 

unapproved drugs.5

As described in the Marketed 

Unapproved Drugs CPG, the agency 

may, at its discretion, identify a period 

of time during which the agency does 

not intend to initiate an enforcement 

action against a currently marketed 

unapproved drug on the ground that it 

lacks an approved application under 

section 505 of the act in order to, for 

example, preserve access to medically 

necessary drugs or ease disruption to 

affected parties. With respect to 

unapproved topical drug products 

containing papain, the agency intends to 

exercise its enforcement discretion for 

only a limited period of time because 

these are drugs with potential safety 

risks that lack scientific evidence of 

effectiveness. Therefore, the agency 

intends to implement this notice as 

follows. 

For the effective date of this notice, 

see the DATES section of this document. 

FDA intends to take action to enforce 

section 505(a) of the act against any 

unapproved topical drug product 

containing papain that is not listed with 

FDA in full compliance with section 

510 of the act (21 U.S.C. 360) before 

September 22, 2008, and that is 

manufactured, shipped, or otherwise 

introduced or delivered for introduction 

into interstate commerce by any person 

on or after September 23, 2008. FDA 

also intends to take action to enforce 

section 505(a) of the act against any 

unapproved topical drug containing 

papain that has a National Drug Code 

(NDC) number listed with FDA in full 

compliance with section 510 of the act 

but is not being commercially used or 

sold6 in the United States on September 

22, 2008, and that is manufactured, 

shipped, or otherwise introduced or 

delivered for introduction into interstate 

commerce by any person on or after 

September 23, 2008. 

However, for unapproved topical drug 

products containing papain that are 

commercially used or sold in the United 

States, have a NDC number listed with 

FDA, and are in full compliance with 

section 510 of the act before September 

22, 2008 (‘‘currently marketed and 

listed’’), the agency intends to exercise 

its enforcement discretion as follows. 

FDA intends to initiate enforcement 

action against any currently marketed 

and listed unapproved topical product 

containing papain that is manufactured 

on or after November 24, 2008 or that 

is shipped on or after January 21, 2009.7

Further, FDA intends to take 

enforcement action against any person 

who manufactures or ships such 

products after the dates set forth above. 

Any person who submits a new drug 

application for a topical drug product 

containing papain but has not received 

approval must comply with this notice. 

The agency, however, does not intend 

to exercise its enforcement discretion as 

outlined previously if the following 

apply: (1) A manufacturer or distributor 

of an unapproved topical drug product 

containing papain covered by this 

notice is violating other provisions of 

the act (including but not limited to, 

violations related to FDA’s current good 

manufacturing practices, adverse drug 

event reporting, or labeling 

requirements) or (2) it appears that a 

firm, in response to this notice, 

increases its manufacture or interstate 

shipment of unapproved topical drug 

products containing papain above its 

usual volume. 

Nothing in this notice, including 

FDA’s intent to exercise its enforcement 

discretion, alters any person’s liability 

or obligations in any other enforcement 

action or litigation, or precludes the 

agency from initiating or proceeding 

with enforcement action in connection 

with any other alleged violation of the 

act, whether or not related to an 

unapproved drug product covered by 

this notice. Similarly, a person who is 

or becomes enjoined from marketing 

unapproved drugs may not resume 

marketing of unapproved topical drug 

products containing papain based on 

FDA’s exercise of enforcement 

discretion as set forth in this notice. 

Drug manufacturers and distributors 

should be aware that the agency is 

exercising its enforcement discretion as 

described previously only in regard to 

topical papain drug products that are 

marketed under an NDC number listed 

with the agency in full compliance with 

section 510 of the act before September 

22, 2008. As previously stated, 

unapproved topical drug products 

containing papain that are not currently 

marketed, or that are currently marketed 

but not listed with the agency on the 

date of this notice must have approved 

applications prior to their shipment in 

interstate commerce. Moreover, any 

person or firm that submits an NDA or 

an ANDA but has yet to receive 

approval for such products is still 

responsible for full compliance with 

this notice. 

C. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 


jlentini on PROD1PC65 with NOTICES
54834 Federal Register / Vol. 73, No. 185 / Tuesday, September 23, 2008 / Notices 

510(j) of the act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

the product NDC number(s), and stating 

that the product(s) has (have) been 

discontinued. The letter should be sent 

to Jennifer Devine (see ADDRESSES). 

Firms should also update the listing of 

their products under section 510(j) of 

the act to reflect discontinuation of 

unapproved topical papain drug 

products. Updating of listing 

information may be advantageous for a 

firm because FDA plans to rely on its 

existing records, the results of a 

subsequent inspection, or other 

available information when we evaluate 

whether to initiate enforcement action. 

This notice is issued under sections 

502 and 505 of the act (21 U.S.C. 352) 

and under authority delegated to the 

Deputy Commissioner for Policy under 

section 1410.10 of the FDA Staff Manual 

Guide. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22300 Filed 9–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program List of Petitions Received 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

publishing this notice of petitions 

received under the National Vaccine 

Injury Compensation Program (‘‘the 

Program’’), as required by Section 

2112(b)(2) of the Public Health Service 

(PHS) Act, as amended. While the 

Secretary of Health and Human Services 

is named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact the Clerk, United States 

Court of Federal Claims, 717 Madison 

Place, NW., Washington, DC 20005, 

(202) 357–6400. For information on 

HRSA(s role in the Program, contact the 

Director, National Vaccine Injury 

Compensation Program, 5600 Fishers 

Lane, Room 11C–26, Rockville, MD 

20857; (301) 443–6593. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the U.S. Court of Federal Claims and to 

serve a copy of the petition on the 

Secretary of Health and Human 

Services, who is named as the 

respondent in each proceeding. The 

Secretary has delegated his 

responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at Section 

2114 of the PHS Act or as set forth at 

42 CFR 100.3, as applicable. This Table 

lists for each covered childhood vaccine 

the conditions which may lead to 

compensation and, for each condition, 

the time period for occurrence of the 

first symptom or manifestation of onset 

or of significant aggravation after 

vaccine administration. Compensation 

may also be awarded for conditions not 

listed in the Table and for conditions 

that are manifested outside the time 

periods specified in the Table, but only 

if the petitioner shows that the 

condition was caused by one of the 

listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa-12(b)(2), requires that the 

Secretary publish in the Federal 

Register a notice of each petition filed. 

Set forth below is a list of petitions 

received by HRSA on April 1, 2007, 

through December 31, 2007. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

(a) ‘‘Sustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Table but which was caused by’’ one of 

the vaccines referred to in the Table, or 

(b) ‘‘Sustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 

This notice will also serve as the 

special master’s invitation to all 

interested persons to submit written 

information relevant to the issues 

described above in the case of the 

petitions listed below. Any person 

choosing to do so should file an original 

and three (3) copies of the information 

with the Clerk of the U.S. Court of 

Federal Claims at the address listed 

above (under the heading ‘‘For Further 

Information Contact’’), with a copy to 

HRSA addressed to Director, Division of 

Vaccine Injury Compensation Program, 

Healthcare Systems Bureau, 5600 

Fishers Lane, Room 11C–26, Rockville, 

MD 20857. The Court’s caption 

(Petitioner’s Name v. Secretary of Health 

and Human Services) and the docket 

number assigned to the petition should 

be used as the caption for the written 

submission. Chapter 35 of title 44, 

United States Code, related to 

paperwork reduction, does not apply to 

information required for purposes of 

carrying out the Program. 

List of Petitions 

1. Annie Jackson, Gary, Indiana, Court 

of Federal Claims Number 07–0217V. 

2. Mildred Free Corun, Murphy, 

North Carolina, Court of Federal Claims 

Number 07–0219V. 

3. Amy and Joel Cochran on behalf of 

Elbrywn Cochran, Scott Air Force Base, 

Illinois, Court of Federal Claims 

Number 07–0221V. 

4. Christine Sharlike on behalf of 

Megan Sharlike. Westerville, Ohio, 

Court of Federal Claims Number 07– 

0229V. 

5. Kristy Paulsen and Shannon 

Berhorst on behalf of Landon Michael 

Lee Berhorst, Deceased, Monticello, 

Missouri, Court of Federal Claims 

Number 07–0233V 

6. Nancey Cost on behalf of Jason 

Cost, Gastonia, North Carolina, Court of 

Federal Claims Number 07–0234V. 

7. Mr. and Mrs. Peter Wynne Wilcox, 

Jr. on behalf of Marshall Wilcox, Macon, 


jlentini on PROD1PC65 with NOTICES