Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 58709 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

section 3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting an emergency review 

because the collection of this 

information is needed before the 

expiration of the normal time limits 

under OMB’s regulations at 5 CFR part 

1320. This is necessary to ensure 

compliance with an initiative of the 

Administration. We cannot reasonably 

comply with the normal clearance 

procedures because the normal 

procedures are likely to cause a 

statutory deadline to be missed which 

may result in public harm. 

Section 1860D–23 and 1860D–24 of 

the Social Security Act, added by the 

Medicare Prescription Drug, 

Improvement and Modernization Act of 

2003 (MMA), requires the Secretary to 

establish requirements for prescription 

drug plans to ensure the effective 

coordination between Part D plans, 

State pharmaceutical assistance 

programs and other payers. These 

requirements have been codified into 

the Code of Federal Regulations at 42 

CFR 423.464. 

Part D sponsors will be responsible 

for making system changes related to 

enrollment file sharing, claims 

processing and payment, reconciliation 

and tracking of the true out-of-pocket 

expenditures of beneficiaries prior to 

the implementation of Part D (January 1, 

2006). System changes must also be 

implemented by State pharmaceutical 

assistance programs so that they may 

provide additional drug benefits at the 

pharmacy to Part D beneficiaries. In 

addition to making system changes, 

these changes must be tested, which 

will require additional time prior to 

January 1, 2006. Failure to make system 

changes may result in the delay in the 

implementation of the program and may 

result in a direct harm to beneficiaries 

since delays or mistakes in claims 

processing may result in beneficiaries 

not receiving their medications, or being 

unable to pay for medications out-ofpocket until the system issue is 

resolved. 

CMS is requesting OMB review and 

approval of this collection by November 

8, 2005, with a 180-day approval period. 

Written comments and 

recommendations will be accepted from 

the public if received by the individuals 

designated below by November 7, 2005. 

Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Coordination of 

Benefits between Part D Plans and Other 

Prescription Coverage Providers; Use: 

This information is necessary to assist 

with coordination of prescription drug 

benefits provided to the Medicare 

beneficiary at the pharmacy; Form 

Number: CMS–10171 (OMB#: 0938–

NEW); Frequency: On occasion and 

monthly; Affected Public: Business or 

other for-profit, Federal, State, Local 

and Tribal Government; Number of 

Respondents: 56,320; Total Annual 

Responses: 2,153,767,270; Total Annual 

Hours: 1,017,914. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

address at http://www.cms.hhs.gov/ 

regulations/pra or e-mail your request, 

including your address, phone number, 

OMB number, and CMS document 

identifier, to paperwork@cms.hhs.gov, 

or call the Reports Clearance Office at 

(410) 786–1326. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

received by the designees referenced 

below by November 7, 2005: Centers for 

Medicare & Medicaid Services, Office of 

Strategic Operations and Regulatory 

Affairs, Room C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

Attn: Melissa Musotto, CMS–10171. 

and, OMB Human Resources and 

Housing Branch, Attention: CMS Desk 

Officer, New Executive Office Building, 

Room 10235, Washington, DC 20503. 

Dated: September 30, 2005. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 05–20229 Filed 10–6–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0178] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Regulations Under the Federal Import 

Milk Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

7, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA 250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Under the regulations implementing 

the Federal Import Milk Act (FIMA) (21 

U.S.C. 141–149), milk or cream may be 

imported into the United States only by 

the holder of a valid import milk permit. 

Before such permit is issued: (1) All 

cows from which import milk or cream 

is produced must be physically 

examined and found healthy; (2) if the 

milk or cream is imported raw, all such 

cows must pass a tuberculin test; (3) the 

dairy farm and each plant in which the 

58710 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 

milk or cream is processed or handled 

must be inspected and found to meet 

certain sanitary requirements; (4) 

bacterial counts of the milk at the time 

of importation must not exceed 

specified limits; and (5) the temperature 

of the milk or cream at time of 

importation must not exceed 50° F. In 

addition, the regulations in part 1210 

(21 CFR part 1210) require that dairy 

farmers and plants maintain 

pasteurization records (§ 1210.15) and 

that each container of milk or cream 

imported into the United States bear a 

tag with the product type, permit 

number, and shipper’s name and 

address (§ 1210.22). 

In the Federal Register of May 31, 

2005 (70 FR 30951), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. 

FDA received one letter in response, 

which contained several comments and 

suggestions. These suggestions and 

FDA’s responses follow. 

The comment stated that the 

collection of information in forms FDA 

1815, FDA 1993, FDA 1994, FDA 1995, 

FDA 1996, and FDA 1997 is necessary 

and that most of these forms provide 

practical information. However, the 

comment requested a number of 

changes to the forms. First, the comment 

suggested that certification of 

tuberculosis-free status in Form FDA 

1815 and Form FDA 1994 should be 

done in a manner consistent with the 

U.S. Department of Agriculture’s 

Animal Plant Health and Inspection 

Service (APHIS) guidelines entitled 

‘‘Bovine Tuberculosis Eradication 

Uniform Methods and Rules’’ (APHIS 

91–45–011). Another comment 

suggested that that Form FDA 1815 and 

Form FDA 1995 include a requirement 

that the submitter certify that the dairy 

cows are free from brucellosis and that 

the certification of brucellosis-free 

status should be done in a manner 

consistent with the APHIS guidelines 

published in the document entitled 

‘‘Brucellosis Eradication: Uniform 

Methods and Rules’’ (APHIS 91–45–

013). 

FDA agrees that, where possible, 

Federal agencies should act in a 

consistent manner. However, FDA 

declines to make the suggested changes 

to its forms because such changes are 

not necessary. The two referenced 

documents are published by APHIS as 

part of its national animal disease 

eradication efforts undertaken by the 

National Center for Animal Health 

Programs under the statutory authority 

provided by the Animal Health 

Protection Act (7 U.S.C. 8301–8320). 

These are domestic programs in the 

United States which are designed to 

address the general health status of U.S. 

domestic cattle. Under the statutory 

authority provided by FIMA, FDA 

regulates all foreign-produced milk and 

cream imported into the United States. 

FIMA requires certification of the 

general health of the animal, which 

certification is obtained by FDA on 

Form FDA 1995. Although the two 

statutory authorities may differ, the 

practices presented in the APHIS 

documents already are being followed 

by FDA. FDA considers the status of the 

brucellosis and tuberculosis control 

programs in the country offering milk 

for importation into the United States 

and bases its acceptance decision on 

that status. 

Another comment stated that Form 

FDA 1996 and Form FDA 1997 do not 

provide practical information and 

should be made consistent with Form 

FDA 2359a, which, the comment states, 

is ‘‘utilized to ensure milk sanitation 

standards are met at the farm level.’’

FDA disagrees that Form FDA 1996, 

‘‘Dairy Farm Sanitation Report,’’ and 

Form FDA 1997, ‘‘Score Card for 

Sanitary Inspection of Milk Plants,’’ do 

not provide practical information. The 

information collected on these two 

forms is used by the agency in 

determining whether the imported milk 

or cream offered for import meet FIMA’s 

requirements for sanitary inspections of 

dairy farms and plants (21 U.S.C. 142). 

FDA also disagrees that the two forms 

should be made consistent with Form 

FDA 2359a because that form is used 

domestically for inspection of facilities 

producing Grade ‘‘A’’ milk products. 

FDA does not use it for inspections of 

facilities producing manufacturinggrade milk domestically. Thus, it would 

be inappropriate for FDA to use it for 

inspection of foreign facilities 

manufacturing non-Grade ‘‘A’’ milk 

products. 

The comment also opposed electronic 

submission of the forms and suggested 

that several changes should be made to 

the requirements of FIMA and the 

agency’s related Compliance Policy 

Guide. These comments are outside the 

scope of the four collection of 

information topics on which the notice 

solicits comments and, thus, will not be 

addressed here. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1

Form No. 21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

FDA 1815/Permits granted 

on certificates 1210.23 8 1 8 0.5 4.0 

FDA 1993/Application of 

permit 1210.20 8 1 8 0.5 4.0 

FDA 1994/Tuberculin test 1210.13 1 1 1 0.5 0.5 

FDA 1995/Physical 

examination of 

cows 1210.12 1 1 1 0.5 0.5 

FDA 1996/Sanitary inspection of dairy 

farms 1210.11 8 200 1,600 1.5 2,400 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices 58711 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Form No. 21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

FDA 1997/Sanitary 

inspections of 

plants 1210.14 8 1 8 2.0 16.0 

Totals 2,425.0 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Record 

Total Annual 

Records 

Hours per 

Recordkeeper Total Hours 

1210.15 8 1 8 .05 0.40 

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

These estimates are based on the 

number of current permit holders and 

the number of inquiries that FDA has 

received regarding requests for 

applications in the past 3 years. No 

burden has been estimated for the 

tagging requirement in § 1210.22 

because the information on the tag is 

either supplied by FDA (permit number) 

or is disclosed to third parties as a usual 

and customary part of the shipper’s 

normal business activities (type of 

product, shipper’s name and address). 

Under 5 CFR 1320.3(c)(2), the public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public is not a 

collection of information. Under 5 CFR 

1320.3(b)(2)), the time, effort, and 

financial resources necessary to comply 

with a collection of information are 

excluded from the burden estimate if 

the reporting, recordkeeping, or 

disclosure activities needed to comply 

are usual and customary because they 

would occur in the normal course of 

activities. Low burden has been 

estimated for Forms FDA 1994 and 1995 

because they are not are not used often. 

The Secretary of Health and Human 

Services has the discretion to allow 

Form FDA 1815, a duly certified 

statement signed by an accredited 

official of a foreign government, to be 

submitted in lieu of Forms FDA 1994 

and 1995. To date, Form FDA 1815 has 

been submitted in lieu of these forms. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20148 Filed 10–6–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0404] 

Pediatric Ethics Subcommittee of the 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of the Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee of the Food and Drug 

Administration (FDA). The meeting will 

be open to the public. 

Name of Committee: Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Pediatric 

Advisory Committee on FDA, and 

certain Department of Health and 

Human Services (HHS), regulatory 

issues. 

Date and Time: The meeting will be 

held on November 15, 2005, from 8:30 

a.m. to 4 p.m. 

Addresses: Electronic copies of the 

documents for public review can be 

viewed at the Pediatric Advisory 

Committee (PAC) Docket site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm. (Click on the year 2005 

and scroll down to Pediatric Ethics 

Subcommittee meeting for 11–15–05.) 

Electronic comments should be 

submitted to http://www.fda.gov/ 

dockets/ecomments. Select Docket No. 

2005N–0404 entitled ‘‘Leuprolide IRB 

Referral’’ and follow the prompts to 

submit your statement. Written 

comments should be submitted to 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Please submit comments by 

4:30 p.m. on November 1, 2005. 

Received comments may be viewed on 

the FDA Web site at: http:// 

www.fda.gov/ohrms/dockets, or may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Location: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD. 

Contact Person: Jan N. Johannessen, 

Office of the Commissioner (HF–33), 

Food and Drug Administration, 5600 

Fishers Lane (for express delivery, rm. 

14C–06), Rockville, MD 20857, 301–

827–6687, or by e-mail: 

jjohannessen@fda.gov. Please call the 

FDA Advisory Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732310001, for up-to-date information 

on this meeting. 

Agenda: The Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee will meet to discuss a 

referral by an Institutional Review 

Board (IRB) of a proposed clinical 

investigation involving children as 

subjects, that is regulated by FDA and 

may be supported by HHS. The 

proposed clinical investigation is 

entitled ‘‘Gonadotropin Releasing 

Hormone (GnRH) Agonist Test in 

Disorders of Puberty.’’ Because the 

proposed clinical investigation would 

be regulated by FDA, and conducted or 

supported by HHS, both FDA and the 

Office for Human Research Protections, 

HHS, will participate in the meeting. 

After presentation of an overview of 

the IRB referral process, background 

information on disorders of puberty and