59272 Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 

recommendations in the draft guidance, 

these establishments could submit a 

single process form that covers all 

container sizes of a product. Thus, the 

estimated number of annual voluntary 

process filings is 2,725 process filings 

(2,251 products/892 establishments x 

540 establishments x 2 = 2,725.4 process 

filings, rounded to 2,725). On average, 

we calculate that the annual frequency 

of reporting would be 5 process filings 

(2,725 process filings/540 

establishments = 5.04, rounded to 5). 

For the purpose of this analysis, we use 

the rounded number of process filings 

(i.e., 5) and, thus, calculate that the 

estimated recurring reporting burden for 

submission of Form 2541a is 2,700 

process filings rather than 2,725 process 

filings (540 establishments x 5 process 

filings per establishment = 2,700 

process filings), resulting in an annual 

reporting burden of 891 hours (2,700 

process filings x 0.33 hours/process 

filing = 891 hours). Table 2 of this 

document includes the estimated onetime and recurring reporting burden for 

establishments that voluntarily submit 

process filings for foods that they 

conclude are acid foods or fermented 

foods that are not also acidified foods. 

We also estimate that all 3,000 

establishments that process foods that 

they conclude are acid foods or 

fermented foods that are not also 

acidified foods and voluntarily register 

their establishments will submit a total 

of 30,000 process filings in the first 

year—i.e., twice as many process filings 

as would be submitted, on average, by 

any given establishment on an annual 

basis (2 x 5 process filings/ 

establishment on an annual basis x 

3,000 establishments = 30,000 process 

filings), resulting in a one-time reporting 

burden of 9,900 hours (30,000 process 

filings x 0.33 hours/establishment = 

9,900 hours). Table 2 of this document 

includes the estimated one-time 

reporting burden for establishments that 

voluntarily submit process filings for 

fermented foods and/or acid foods. 

TABLE 2.—ESTIMATED ONE-TIME AND RECURRING REPORTING BURDEN1

Activity No. of 

Reporters 

Annual Frequency 

per Reporter 

Total Annual 

Records 

Hours per 

Record Total Hours 

Registration (Form FDA 2541)2 2,250 1 2,250 0.17 383 

Registration (Form FDA 2541) 180 1 180 0.17 31 

Process filing (Form FDA 

2541a)2 3,000 10 30,000 0.33 9,900 

Process filing (Form FDA 

2541a) 540 5 2,700 0.33 891 

Total one-time burden 10,283 

Total recurring burden 922 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2One-time reporting burden. 

III. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov or at http://

www.fda.gov/FoodGuidances. 

V. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen between 9 a.m. and 4 

p.m., Monday through Friday. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to Web site after this document 

publishes in the Federal Register.) 

1. Codex Alimentarius Commission, 

Recommended International Code of 

Hygienic Practice for Low and Acidified Low 

Acid Canned Foods CAC/RCP 23–1979, Rev. 

2 (1993), Available at http://www.codex

alimentarius.net/download/standards/24/

CXP_023e.pdf, Accessed and printed on June 

17, 2008. 

Dated: September 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24089 Filed 9–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1820–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application from 

a Hospital Requesting Waiver for 

Organ Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a 

waiver of statutory requirements that 

would otherwise require the hospital to 

enter into an agreement with its 

designated Organ Procurement 

Organization (OPO). The request was 

made in accordance with section 

1138(a)(2) of the Social Security Act (the 

Act). This notice requests comments 

from OPOs and the general public for 

our consideration in determining 

whether we should grant the requested 

waiver. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 59273 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

November 26, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1820–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1820–NC, P.O. Box 8010, 

Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Department of 

Health and Human Services, Attention: 

CMS–1820–NC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of transplantable organs to 

transplant centers throughout the 

country. Qualified OPOs are designated 

by the Centers for Medicare & Medicaid 

Services (CMS) to recover or procure 

organs in CMS-defined exclusive 

geographic service areas, pursuant to 

section 371(b)(1) of the Public Health 

Service Act (42 U.S.C. 273(b)(1) and our 

regulations at 42 CFR 486.306. Once an 

OPO has been designated for an area, 

hospitals in that area that participate in 

Medicare and Medicaid are required to 

work with that OPO in providing organs 

for transplant, pursuant to section 

1138(a)(1)(C) of the Social Security Act 

(the Act) and our regulations at 42 CFR 

§ 482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement to identify 

potential donors only with its 

designated OPO. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

a waiver of the above requirements from 

the Secretary under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one initially designated by 

CMS, if the hospital meets certain 

conditions specified in section 

1138(a)(2)(A) of the Act. In addition, the 

Secretary may review additional criteria 

described in section 1138(a)(2)(B) of the 

Act to evaluate the hospital’s request for 

a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to comment in 

writing during the 60-day period 

beginning on the publication date in the 

Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information hospitals 

must provide in requesting a waiver. We 

indicated that upon receipt of a waiver 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the request and comments 

received. During the review process, we 

may consult on an as-needed basis with 

the Health Resources and Services 


srobinson on DSKHWCL6B1PROD with NOTICES
59274 Federal Register / Vol. 75, No. 186 / Monday, September 27, 2010 / Notices 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Requests 

As permitted by § 486.308(e), the 

following hospital has requested a 

waiver in order to enter into an 

agreement with a designated OPO other 

than the OPO designated for the service 

area in which the hospital is located: 

War Memorial Hospital (Medicare 

provider number 51–1309), of Berkeley 

Springs, West Virginia, is requesting a 

waiver to work with: 

LifeNet Health, 1864 Concert Drive, 

Virginia Beach, VA 23453. 

The Hospital’s Designated OPO is: 

Center for Organ Recovery and 

Education, RIDC Park, 204 Sigma 

Drive, Pittsburgh, PA 15238. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare— 

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: September 21, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–24100 Filed 9–24–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1825–NC] 

Medicare and Medicaid Programs; 

Announcement of Application from 

Hospital Requesting Waiver for Organ 

Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a 

waiver of statutory requirements that 

would otherwise require the hospital to 

enter into an agreement with its 

designated Organ Procurement 

Organization (OPO). The request was 

made in accordance with section 

1138(a)(2) of the Social Security Act (the 

Act). This notice requests comments 

from OPOs and the general public for 

our consideration in determining 

whether we should grant the requested 

waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

November 26, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1825–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–1825–NC, P.O. Box 8010, 

Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Department of 

Health and Human Services, Attention: 

CMS–1825–NC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to one of 

the following addresses prior to the 

close of the comment period: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of transplantable organs to 

transplant centers throughout the 

country. Qualified OPOs are designated 

by the Centers for Medicare & Medicaid 

Services (CMS) to recover or procure 

organs in CMS-defined exclusive 

geographic service areas, pursuant to 

section 371(b)(1) of the Public Health 

Service Act (42 U.S.C. 273(b)(1) and our 

regulations at 42 CFR 486.306. Once an 

OPO has been designated for an area, 

hospitals in that area that participate in 

Medicare and Medicaid are required to 


srobinson on DSKHWCL6B1PROD with NOTICES