Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 59355 

TABLE 3.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR BIOLOGICS1—Continued 

REPORTING BURDEN 

21 CFR Section No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

312.54(a) and (b) 1 1 1 48 48 

312.55(b) 138 2 .5 347 48 16,656 

312.56(b) and (d) 14 1 .6 23 80 1,840 

312.58(a) 8 1 8 8 64 

312.64(a) through (d) 6,003 3 .5 21,185 24 508,440 

312.70(a) 6 1 6 40 240 

312.110(b) 21 1 21 75 1,575 

312.130(d) 1 1 1 8 8 

Total reporting burden 4,338,643 

RECORDKEEPING BURDEN 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

312.52(a) 139 1 .4 200 2 400 

312.57(a) and (b) 433 2 .6 1,114 100 111,400 

312.62(a) 5,570 1 5,570 40 222,800 

312.62(b) 5,570 10 55,700 40 2,228,000 

312.160(a)(3) 146 1 .4 211 0 .5 105.5 

312.160(c) 146 1 .4 211 0 .5 105.5 

Total recordkeeping burden 2,562,811 

Total biologics burden hours 6,901,454 

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

TABLE 4.—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN FOR HUMAN DRUGS AND BIOLOGICS1

Total human drugs burden hours ........................................................................................................................................................ 64,475,247 

Total biologics burden hours ............................................................................................................................................................... 6,901,454 

Total burden hours .............................................................................................................................................................................. 71,376,701 

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

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20362 Filed 10–11–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting 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 Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel. ‘‘Review of an Unsolicited 

P01.’’

Date: October 26, 2005. 

Time: 10 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817, (Telephone Conference 

Call). 

Contact Person: Cheryl K. Lapham, PhD, 

Scientific Review Administrator, Scientific 

Review Program, National Institute of Allergy 

and Infectious Diseases, DEA/NIH/DHHS, 

6700–B Rockledge Drive, MSC 7616, Room 

3127, Bethesda, MD 20892–7616, 301–402–

4598, clapham@niaid.nih.gov. 

59356 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Notices 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: October 3, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–20431 Filed 10–11–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 552(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 Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel. Research Training 

in Pediatric Gastroenterology. 

Date: October 26, 2005. 

Time: 11 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Xiaodu Guo, MD, PhD, 

Scientific Review Administrator, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 705, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–4719, guox@extra.niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel. Sphincter of Oddi 

Dysfunction. 

Date: November 1, 2005. 

Time: 1:30 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Atul Sahai, PhD, Scientific 

Review Administrator, Review Branch, DEA, 

NIDDK, National Institues of Health, Room 

772, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452, (301) 594–2242, 

sahaia@extra.niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: October 02, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–20432 Filed 10–11–05; 8:45am] 

BILLING CODE Code 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Board of Scientific 

Counselors, National Library of 

Medicine, October 25, 2005, 9 a.m. to 

October 25, 2005, 5 p.m., National 

Library of Medicine, Building 38, Board 

Room, 2nd Floor, 8600 Rockville Pike, 

Bethesda, MD 20892 which was 

published in the Federal Register on 

August 16, 2005, 70 FR 48166. 

In addition to the October 25, 2005 

meeting, there will be a meeting on 

October 24, 2005 from 5 p.m. to 7 p.m. 

at the Bethesda Marriott, 5151 Pooks 

Hill Road, Bethesda, Maryland 20892. 

The meeting is partially closed to the 

public. 

Dated: October 3, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–20430 Filed 10–11–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 

This notice is also available on the 

Internet at http://workplace.samhsa.gov 

and http://www.drugfreeworkplace.gov. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh or Dr. Walter Vogl, 

Division of Workplace Programs, 

SAMHSA/CSAP, Room 2–1035, 1 Choke 

Cherry Road, Rockville, Maryland 

20857; (240) 276–2600 (voice), (240) 

276–2610 (fax). 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were developed 

in accordance with Executive Order 

12564 and section 503 of Public Law 

100–71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

Testing for Federal Agencies,’’ sets strict 

standards that laboratories must meet in 

order to conduct drug and specimen 

validity tests on urine specimens for 

Federal agencies. To become certified, 

an applicant laboratory must undergo 

three rounds of performance testing plus 

an on-site inspection. To maintain that 

certification, a laboratory must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories which claim to be in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines. A laboratory 

must have its letter of certification from 

HHS/SAMHSA (formerly: HHS/NIDA) 

which attests that it has met minimum 

standards. 

In accordance with Subpart C of the 

Mandatory Guidelines dated April 13, 

2004 (69 FR 19644), the following 

laboratories meet the minimum