Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 26967 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

of Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1002.30 and 1002.31(a) 1,150 1,655.5 1,903,825 0.12 228,459 

1002.40 and 1002.41 2,950 49.2 145,140 0.05 7,257 

1020.30(g) 22 1 22 0.5 11 

1040.10(a)(3)(ii) 40 1 40 1.0 40 

Totals 235,767 

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

The burden estimates were derived by 

consultation with FDA and industry 

personnel, and are based on actual data 

collected from industry. An evaluation 

of the type and scope of information 

requested was also used to derive some 

time estimates. For example, disclosure 

information primarily requires time 

only to update and maintain existing 

manuals. Initial development of 

manuals has been performed except for 

new firms entering the industry. 

The following information collection 

requirements are not subject to review 

by OMB because they do not constitute 

a ‘‘collection of information’’ under the 

PRA: Sections 1002.31(c); 1003.10(a), 

(b), and (c); 1003.11(a)(3) and (b); 

1003.20(a) through (h); 1003.21(a) 

through (d); 1003.22(a) and (b); 

1003.30(a) and (b); 1003.31(a) and (b); 

1004.2(a) through (i); 1004.3(a) through 

(i); 1004.4(a) through (h); 1005.21(a) 

through (c); and 1005.22(b). These 

requirements apply to the collection of 

information during the conduct of 

general investigations or audits (5 CFR 

1320.4(b)). 

The following labeling requirements 

are also not subject to review under the 

PRA because they are a public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public (5 CFR 

1320.3(c)(2)): Sections 1020.10(c)(4), 

1030.10(c)(6), 1040.10(g), 1040.30(c)(1), 

and 1050.10(d)(1). 

Dated: May 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11396 Filed 5–12–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0236] 

Guidance for Industry: Use of Water by 

Food Manufacturers in Areas Subject 

to a Boil-Water Advisory; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for Industry: Use of Water by 

Food Manufacturers in Areas Subject to 

a Boil-Water Advisory.’’ This guidance 

is intended to advise food 

manufacturers that once a boil-water 

advisory has been issued they should 

stop using the water subject to the 

advisory until the water again meets the 

applicable Federal and State drinking 

water quality standards. Further, this 

guidance is intended to assist food 

manufacturers in evaluating food that 

already was produced with water 

subject to the advisory. The guidance is 

in response to the recent major water 

pipe break in Massachusetts that 

interrupted service to 30 Massachusetts 

Water Resources Authority (MWRA) 

customer communities (serving 

approximately 2 million residents). 

DATES: Submit electronic or written 

comments on the guidance at any time. 

ADDRESSES: Submit electronic 

comments on the guidance to http:// 

www.regulations.gov. Submit written 

comments on the guidance to the 

Division of Dockets Management 

(HFA—305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

written requests for single copies of the 

guidance to the Office of Food Safety, 

Center for Food Safety and Applied 

Nutrition (HFS–300), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Jenny Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1700 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Guidance for 

Industry: Use of Water by Food 

Manufacturers in Areas Subject to a 

Boil-Water Advisory.’’ This guidance is 

intended to advise food manufacturers 

that once a boil-water advisory has been 

issued they should stop using the water 

subject to the advisory until the water 

again meets the applicable Federal and 

State drinking water quality standards. 

Further, this guidance is intended to 

assist food manufacturers in evaluating 

food that already was produced with 

water subject the advisory. 

FDA is issuing this guidance as Level 

1 guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). Consistent with FDA’s good 

guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately in accordance with 21 CFR 

10.115(g)(2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the recent 

major water pipe break in Massachusetts 

that interrupted service to 30 MWRA 

customer communities (serving 

approximately 2 million residents). The 

guidance represents the agency’s current 

thinking on the use of water by food 

manufacturers in areas subject to a 

‘‘Boil-Water Advisory.’’ It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternate approach may be 


sroberts on DSKD5P82C1PROD with NOTICES
26968 Federal Register / Vol. 75, No. 92 / Thursday, May 13, 2010 / Notices 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding the guidance. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/FoodGuidances or http:// 

www.regulations.gov. 

Dated: May 10, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–11450 Filed 5–10–10; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; NEI Loan 

Repayment Grants. 

Date: May 18–19, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Eye Institute, 5635 Fishers 

Lane, Bethesda, MD (Virtual Meeting). 

Contact Person: Daniel R. Kenshalo, PhD, 

Scientific Review Officer, National Eye 

Institute, National Institutes of Health, 5635 

Fishers Lane, Suite 1300, MSC 9300, 

Bethesda, MD 20892, 301–451–2020, 

kenshalod@nei.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; SBIR Grant 

Application. 

Date: May 20, 2010. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Eye Institute, 5635 Fishers 

Lane, Suite 1300, Rockville, MD 20892. 

Contact Person: Samuel Rawlings, PhD, 

Chief, Scientific Review Branch, Division Of 

Extramural Research, National Eye Institute, 

5635 Fishers Lane, Suite 1300 MSC 9300, 

Bethesda, MD 20892–9300, 301–451–2020, 

rawlings@nei.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

May 6, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–11307 Filed 5–12–10; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Adult 

Brain Tumor Consortium. 

Date: May 20, 2010. 

Time: 1 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room 6006, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Gerald G. Lovinger, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8101, Bethesda, MD 

20892–8329, 301/496–7987, 

lovingeg@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Small 

Grants Program for Cancer Epidemiology. 

Date: June 17–18, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Legacy Hotel and Meeting Center, 

1775 Rockville Pike, Rockville, MD 20852. 

Contact Person: Joyce C. Pegues, B.S., B.A., 

PhD, Scientific Review Officer, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Boulevard, 

Room 7149, Bethesda, MD 20892–8329, 301– 

594–1286, peguesj@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Innovative 

Technology Development. 

Date: June 23–24, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: Jeffrey E. DeClue, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Boulevard, Room 8059, 

Bethesda, MD 20892–8329, 301–496–7904, 

decluej@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Comprehensive Minority Institution Cancer 

Center Partnership. 

Date: June 29–30, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Lalita D. Palekar, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 7141, Bethesda, 

MD 20892, 301–496–7575, 

palekarl@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Nanotechnology Imaging and Sensing 

Platforms. 

Date: June 29, 2010. 

Time: 11 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Conference Room 707, 

Rockville, MD 20852 (Telephone Conference 

Call). 


sroberts on DSKD5P82C1PROD with NOTICES