60768 Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 

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

corporations, or associations (section 201 of the 

Federal Food, Drug, and Cosmetic Act (the act) (21 

U.S.C. 321(e)). 

2Because the incidence of FMF in the United 

States is rare, Mutual sought and was granted 

orphan drug status for its product covered by NDA 

22–352 under section 526 of the act (21 U.S.C. 

360bb). The term ‘‘orphan drug’’ refers to a product 

that treats a rare disease affecting fewer than 

200,000 Americans. Enacted in 1983, the intent of 

the Orphan Drug Act is to stimulate the research, 

development, and approval of products that treat 

Health and Human Services. The four 

cross-cutting strategic priorities are: (1) 

Advance Regulatory Science and 

Innovation, (2) Strengthen the Safety 

and Integrity of the Global Supply 

Chain, (3) Strengthen Compliance and 

Enforcement Activities to Support 

Public Health, and (4) Expand Efforts to 

Meet the Needs of Special Populations. 

The four strategic program goals are: (1) 

Advance Food Safety and Nutrition, (2) 

Promote Public Health by Advancing 

the Safety and Effectiveness of Medical 

Products, (3) Establish an Effective 

Tobacco Regulation, Prevention, and 

Control Program, and (4) Manage for 

Organizational Excellence and 

Accountability. 

The strategic planning process is an 

opportunity for FDA to further refine 

and strengthen the strategic 

management structure currently in 

place. For comparison purposes, the 

current FDA Strategic Action Plan 2007 

can be viewed at http://www.fda.gov/ 

downloads/AboutFDA/Reports

ManualsForms/Reports/Strategic

ActionPlan/UCM061415.pdf. 

FDA has made significant progress in 

its strategic planning efforts. As we 

build on this progress we look forward 

to receiving your comments by (see 

DATES). The text of the draft strategic 

priorities document is available in a 

‘‘pdf’’ (portable document format) 

downloadable format through FDA’s 

Web site: http://www.fda.gov/ 

AboutFDA/. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24603 Filed 9–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0257] 

Single-Ingredient Oral Colchicine 

Products; Enforcement Action Dates 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or agency) is 

announcing its intention to take 

enforcement action against unapproved 

single-ingredient oral colchicine 

products and persons1 who manufacture 

or cause the manufacture of such 

products or their shipment in interstate 

commerce. Unapproved singleingredient oral colchicine products have 

been associated with serious adverse 

events, including fatalities. Singleingredient oral colchicine products are 

new drugs that require approved 

applications because they are not 

generally recognized as safe and 

effective. Currently one firm has 

obtained approved applications to 

market single-ingredient oral colchicine 

for the treatment of acute gout flares, 

prophylaxis of gout flares, and 

prophylaxis of attacks of Familial 

Mediterranean Fever (FMF). All other 

manufacturers who wish to market 

single-ingredient oral colchicine 

products for these or other indications 

must obtain FDA approval of a new 

drug application (NDA) or an 

abbreviated new drug application 

(ANDA). 

DATES: This notice is effective October 

1, 2010. For information about 

enforcement dates, see SUPPLEMENTARY

INFORMATION, section III.C. 

ADDRESSES: All communications in 

response to this notice should be 

identified with Docket No. FDA–2010– 

N–0257 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 Anesthesia, 

Analgesia and Rheumatology 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: See the 

FOR FURTHER INFORMATION CONTACT

section of this document. 

FOR FURTHER INFORMATION CONTACT: 

Karen Rothschild, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5237, 

Silver Spring, MD 20993–0002, 301– 

796–3689, e-mail: 

Karen.Rothschild@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Colchicine is an alkaloid of the 

Colchicum autumnale plant, also 

known as autumn crocus or meadow 

saffron. Colchicum was initially 

described in the 1st century A.D. by 

Dioscorides in the Materia Medica. 

Medical use of colchicum for gout pain 

dates back to the 6th century. It was 

used for several centuries, but the use of 

colchicum in the treatment of gout 

substantially declined by the 15th 

century because of its toxicity. 

Colchicum was reintroduced as a 

treatment for acute gout beginning in 

1763. Colchicine was first isolated from 

colchicum in 1820 and made available 

in oral dosage form during the 19th 

century. Colchicine in oral dosage form 

is currently marketed in the United 

States as approved and unapproved 

products, both as a single ingredient and 

in combination with probenecid. 

Colchicine for injection has been 

available in the United States since the 

1950s and has been administered 

intravenously for the treatment of acute 

gout flares. In the Federal Register of 

February 8, 2008 (73 FR 7565), FDA 

announced its intention to take 

enforcement action against unapproved 

drug products containing colchicine for 

injection. Single-ingredient oral 

colchicine products, the subject of this 

notice, have also been marketed in the 

United States without approved 

applications to treat acute gout flares, 

and are more commonly marketed in 

conjunction with uric acid lowering 

agents for the daily prophylaxis of flares 

of gout. Daily oral colchicine has also 

been the standard of care since the 

1970s for the prophylaxis of attacks of 

FMF. 

One firm, Mutual Pharmaceutical Co., 

Inc. (Mutual), of Philadelphia, PA, has 

received approval for three NDAs for 

single-ingredient oral colchicine. These 

approvals are: NDA 22–352 for the 

treatment of FMF,2 approved on July 29, 


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Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 60769 

rare diseases. Under this law, which amended the 

act and is provided in sections 525 through 529 (21 

U.S.C. 360aa through 360ee), a firm that receives 

approval for a product designated as an orphan 

drug receives for the product a special period of 

exclusivity of 7 years after the date of approval, 

during which the agency will not approve another 

application for the same drug for the same 

condition submitted by another applicant (see 21 

CFR 316.3). 

3 Data in the current system (AERS) date back to 

when the adverse event reporting system was first 

implemented in 1969. 

2009; NDA 22–351 for the treatment of 

acute gout flares, approved on July 30, 

2009; and NDA 22–353 for the treatment 

of chronic gout, approved on October 

16, 2009. Mutual is marketing these 

products under the trade name 

COLCRYS. These approvals were based 

on extensive evaluation of studies and 

new data that permitted refinement of 

dosing regimens and labeling. When 

used in accordance with the approved 

labeling, single-ingredient oral 

colchicine was found to be welltolerated and safe when taken at 

therapeutic doses and with appropriate 

dose reductions in susceptible 

populations or with potentially 

interacting drugs. 

II. Safety Issues in the Use of SingleIngredient Oral Colchicine Products 

The most frequent adverse effects of 

oral colchicine in therapeutic doses are 

those involving the gastrointestinal 

tract, with the most common adverse 

events being diarrhea, nausea and 

vomiting, abdominal pain, and 

cramping. These events are often the 

first indication that colchicine therapy 

may need to be stopped or the dose 

reduced. Overdose with colchicine is 

uncommon, despite its narrow 

therapeutic index and despite wide 

variation in the dose required for 

significant morbidity and mortality. 

Approximately 20 adverse event reports 

including 5 deaths are reported to the 

agency on average per year. However, 

above the typical therapeutic doses 

(which range from a 2.4-milligram (mg) 

maximum daily chronic dose to the 4.8- 

mg maximum acute dose), there does 

not seem to be any clear separation 

between nontoxic, toxic, or lethal doses 

of colchicine. Overall, FDA is aware of 

751 reports of adverse events associated 

with colchicine toxicity, including 169 

deaths associated with oral colchicine, 

through June 2007.3

There is also evidence supporting a 

potentially lethal interaction between Pglycoprotein (P-gp) inhibitors/strong 

cytochrome P450 3A4 (CYP3A4) 

inhibitors (such as clarithromycin) and 

colchicine. Although these interactions 

have been published in the medical 

literature, fatal interactions continue to 

be reported to postmarketing adverse 

event databases. Postmarketing adverse 

event databases, including FDA’s AERS 

database, reveal that half of nonoverdose colchicine fatalities are related 

to the concommitant use of colchicine 

and clarithromycin. This information 

suggests that despite the literature, 

awareness regarding colchicine 

interactions may not be widespread in 

the healthcare community. Another 

variable in this equation is that 

interactions are potentially more severe 

and lethal in patients with an 

underlying susceptibility. Based on the 

published literature, a 4-fold decrease in 

colchicine clearance is noted in severely 

renally impaired subjects undergoing 

hemodialysis compared to healthy 

volunteers. A 2.5- to 10-fold lower 

clearance has been reported in cirrhotic 

patients when compared to healthy 

subjects. No pharmacokinetic studies 

have been performed in the elderly or in 

pediatric patients. However, because the 

elderly are more likely to have 

significant renal or hepatic impairment, 

as a whole, they are more at risk. In light 

of these safety concerns, there are 

specific dose modification and 

reduction recommendations in the 

recently approved colchicine labeling 

pertaining to drug interactions and to 

patients with renal impairment. 

Furthermore, a new clinical trial in 

acute gout that was conducted in 

support of the NDA found that a lower 

dose of oral colchicine than had been 

considered the standard of care was just 

as effective for the treatment of an acute 

gout flare, and resulted in fewer adverse 

events. The approved labeling for oral 

colchicine reflects this newly 

discovered information. 

In general, the labeling for 

unapproved single-ingredient oral 

colchicine products listed with FDA 

under section 510(j) of the act (21 U.S.C. 

360(j)) does not reflect the most current 

data regarding the safety and 

effectiveness of single-ingredient oral 

colchicine. As noted previously in this 

document, the newly approved labeling 

reflects the new dosing for acute gout 

flares. Additionally, based on 

pharmacokinetic studies conducted in 

support of the approved NDAs, new 

specific-dose modification and 

reduction recommendations are 

provided in the approved colchicine 

labeling for its use with drugs that use 

certain enzymes, such as CYP3A4 or Pgp, for their metabolism or absorption. 

Because no applications have been 

submitted to and reviewed by FDA for 

the unapproved single-ingredient oral 

colchicine products, the safety and 

effectiveness of these unapproved 

products cannot be assured. 

The expected risks associated with 

use of oral products that contain singleingredient colchicine are potentially 

greater for unapproved products 

because the quality, safety, and efficacy 

of unapproved formulations have not 

been demonstrated to FDA. For 

example, the ingredients and 

bioavailability of unapproved products 

have not been submitted for FDA 

review, nor has FDA had the 

opportunity to assess the adequacy of 

their chemistry, manufacturing, and 

controls specifications. Further, as 

noted previously, a clinical trial 

revealed that a substantially lower dose 

of colchicine is as effective as the higher 

dose traditionally considered to be the 

standard of care, with significantly 

reduced adverse reactions. Because FDA 

has not approved the labeling for 

unapproved single-ingredient colchicine 

products, their labeling likely does not 

contain appropriate dosing and drug 

interaction information. 

III. Legal Status 

A. Current Status of Single-Ingredient 

Oral Colchicine 

As stated previously, only one firm, 

Mutual Pharmaceutical, Inc. (Mutual), 

has obtained approved applications for 

single-ingredient oral colchicine tablets. 

Mutual submitted three NDAs for its 

single-ingredient colchicine tablets: 

NDA 22-352 for the indication of FMF, 

which was approved on July 29, 2009; 

NDA 22-351 for the treatment of acute 

gout, which was approved on July 30, 

2009; and NDA 22-353 for the 

prevention of gout flares in the chronic 

treatment of gout, which was approved 

on October 16, 2009. Mutual is 

marketing these products under the 

trade name COLCRYS. As stated 

previously, because the incidence of 

FMF in the United States is rare, Mutual 

sought and was granted orphan drug 

status for its product covered by NDA 

22–352 under section 526 of the act. 

Unapproved single-ingredient oral 

colchicine tablets are also available on 

the market. The agency reviewed the 

labeling of unapproved colchicine 

products listed with FDA under section 

510(j) of the act. In general, labeling for 

the unapproved products does not 

reflect the most current data regarding 

single-ingredient oral colchicine. As 

noted previously, the newly approved 

labeling reflects the new dosing for 

acute gout flares. Based on 

pharmacokinetic studies, new specificdose modification and reduction 

recommendations are provided in the 

approved colchicine label for its use 


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60770 Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 

4The agency’s general approach for dealing with 

these products in an orderly manner is spelled out 

in the Marketed Unapproved Drugs CPG. 

5For the purpose 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’’)). 

with drugs that use certain enzymes, 

such as CYP3A4 or P-gp, for their 

metabolism or absorption. Because no 

applications have been filed and 

reviewed by the agency for the 

unapproved products, the safety and 

effectiveness of these products cannot 

be ensured. 

B. Single-Ingredient Oral Colchicine 

Products Are New Drugs Requiring 

Approved Applications 

Based on both the safety 

considerations previously described and 

the absence of published literature 

documenting that single-ingredient oral 

colchicine is safe and effective, 

unapproved single-ingredient oral 

colchicine is not generally recognized as 

safe and effective for any indication 

including treatment of acute gout flares 

or for the daily prophylaxis of gout. 

Agency review of individual 

applications to ensure appropriate 

manufacturing and labeling is required 

to ensure the safe and effective use of 

the drug. Therefore, single-ingredient 

oral colchicine is regarded as a new 

drug as defined in section 201(p) of the 

act (21 U.S.C. 321(p)) and is subject to 

the requirements of section 505 of the 

act. As set forth in this notice, approval 

of an NDA or ANDA under section 505 

of the act is required as a condition for 

manufacturing or marketing all singleingredient oral colchicine products. Any 

person who submits an application for 

a single-ingredient oral colchicine 

product but has not received approval 

must comply with this notice. 

C. 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 single-ingredient 

oral colchicine products that after the 

dates identified in this notice, 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 single-ingredient oral 

colchicine products can result in 

enforcement action, including seizure, 

injunction, or other judicial or 

administrative proceedings. 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 marketing 

unapproved single-ingredient oral 

colchicine products prior to taking 

enforcement action. The agency also 

reminds firms 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.4

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 single-ingredient 

oral colchicine products, the agency 

intends to exercise its enforcement 

discretion for only a limited period of 

time because single-ingredient oral 

colchicine products are drugs with 

potential safety risks and, in light of the 

fact that the agency has approved 

applications for single-ingredient oral 

colchicine products for the treatment of 

acute gout flairs, prophylaxis of gout 

flares, and prophylaxis of attacks of 

FMF, the continued marketing of 

unapproved single-ingredient oral 

colchicine products is a direct challenge 

to the drug approval process. Therefore, 

the agency intends to implement this 

notice as follows. 

This notice is effective October 1, 

2010. FDA intends to take action to 

enforce section 505(a) of the act against 

any unapproved single-ingredient oral 

colchicine products that are not listed 

with FDA in full compliance with 

section 510 of the act before September 

30, 2010, and that are manufactured, 

shipped, or otherwise introduced or 

delivered for introduction into interstate 

commerce by any person on or after 

October 1, 2010. FDA also intends to 

take action to enforce section 505(a) of 

the act against any unapproved singleingredient oral colchicine products that 

have a National Drug Code (NDC) 

number listed with FDA in full 

compliance with section 510 of the act 

but were not being commercially used 

or sold5 in the United States on 

September 30, 2010, and that are 

manufactured, shipped, or otherwise 

introduced or delivered for introduction 

into interstate commerce by any person 

on or after October 1, 2010. 

However, for unapproved singleingredient oral colchicine products that 

are commercially used or sold in the 

United States, have an NDC number 

listed with FDA, and are in full 

compliance with section 510 of the act 

before September 30, 2010 (‘‘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 single-ingredient oral 

colchicine products that are 

manufactured on or after November 15, 

2010, or that are shipped on or after 

December 30, 2010.6 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 a singleingredient oral colchicine 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 either of the 

following applies: (1) A manufacturer or 

distributor of an unapproved singleingredient oral colchicine product is 

violating any 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 unapproved singleingredient oral colchicine products 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 60771 

or becomes enjoined from marketing 

unapproved drugs may not resume 

marketing of unapproved singleingredient oral colchicine 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 

unapproved single-ingredient oral 

colchicine products that are marketed 

under an NDC number listed with the 

agency in full compliance with section 

510 of the act before September 30, 

2010. As previously stated, unapproved 

single-ingredient oral colchicine 

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 before shipment in 

interstate commerce. 

D. 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 

the product NDC number(s), and stating 

that the product(s) has (have) been 

discontinued. The letter should be sent 

electronically to edrls@fda.hhs.gov. 

Firms should also update the listing of 

their products under section 510(j) of 

the act to reflect discontinuation of 

unapproved single-ingredient colchicine 

products. 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 the act 

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

and under authority delegated to the 

Deputy Commissioner, Office of Policy, 

Planning and Budget under section 

1410.21 of the FDA Staff Manual Guide. 

Dated: September 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24684 Filed 9–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2010–0080] 

Critical Infrastructure Partnership 

Advisory Council (CIPAC) 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: Notice of CIPAC meeting. 

SUMMARY: The CIPAC will meet on 

October 13, 2010 in Bethesda, MD. The 

meeting will be open to the public. 

DATES: The CIPAC will meet 

Wednesday, October 13, 2010 from 8:30 

a.m. to 12:30 p.m. Please note that the 

meeting may adjourn early if the 

committee has completed its business. 

For additional information, please 

consult the CIPAC Web site, http:// 

www.dhs.gov/cipac, or contact the 

CIPAC Secretariat by phone at 703–235– 

3999 or by e-mail at cipac@dhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Renee Murphy, Section Chief 

Partnership Programs, Partnership and 

Outreach Division, Office of 

Infrastructure Protection, National 

Protection and Programs Directorate, 

United States Department of Homeland 

Security, Mail Stop 0607, 245 Murray 

Lane, SW., Washington, DC 20528– 

0607, telephone 703–235–3999 or via email at CIPAC@dhs.gov. 

Responsible DHS Official: Renee 

Murphy, Section Chief Partnership 

Programs, Partnership and Outreach 

Division, Office of Infrastructure 

Protection, National Protection and 

Programs Directorate, United States 

Department of Homeland Security, Mail 

Stop 0607, SW., 245 Murray Lane, SW., 

Washington, DC 20528–0607, telephone 

703–235–3999 or e-mail at 

CIPAC@dhs.gov. 

SUPPLEMENTARY INFORMATION: CIPAC 

represents a partnership between the 

Federal Government and critical 

infrastructure owners and operators and 

provides a forum in which they can 

engage in a broad spectrum of activities 

to support and coordinate critical 

infrastructure protection. 

The CIPAC will meet to discuss issues 

relevant to the protection of critical 

infrastructure. The October 13, 2010 

meeting will include panel discussions 

between participating Sectors regarding 

Regionalization and Resilience and 

Information Sharing. 

Procedural: While this meeting is 

open to the public, participation in the 

CIPAC deliberations is limited to 

committee members, DHS officials, and 

persons invited to attend the meeting for 

special presentations. 

Information on Services for 

Individuals with Disabilities: For 

information on facilities or services for 

individuals with disabilities or to 

request special assistance at the 

meeting, contact the CIPAC Secretariat 

at 703–235–3999 as soon as possible. 

Signed: September 24, 2010. 

Renee Murphy, 

Alternate Designated Federal Officer for the 

CIPAC. 

[FR Doc. 2010–24670 Filed 9–30–10; 8:45 am] 

BILLING CODE 9110–9P–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: New Information Collection; 

Comment Request 

ACTION: 60-day notice of information 

collection under review: E-Verify Self 

Check Program (Internal File Number 

OMB–59). 

The Department Homeland Security, 

U.S. Citizenship and Immigration 

Services (USCIS) will be submitting the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty days until November 30, 2010. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), USCIS, Chief, Regulatory 

Products Division, Clearance Officer, 

20 Massachusetts Avenue, NW., 

Washington, DC 20529–2020. 

Comments may also be submitted to 

DHS via facsimile to 202–272–8352 or 

via e-mail at rfs.regs@dhs.gov. When 

submitting comments by e-mail, please 

make sure to add Control No. OMB–59 

in the subject box. Written comments 

and suggestions from the public and 

affected agencies concerning the 

collection of information should address 

one or more of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 


emcdonald on DSK2BSOYB1PROD with NOTICES