Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 75483 

Drug Products; Questions and Answers.’’ 

This document answers questions 

regarding CVM’s implementation of 

USP <467> Residual Solvents. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in this guidance have 

been approved under OMB control nos. 

0910–0032 and 0910–0669. 

IV. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: November 12, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30387 Filed 12–2–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0533] 

Guidance for Industry: 

Recommendations for Blood 

Establishments: Training of Back-Up 

Personnel, Assessment of Blood 

Donor Suitability, and Reporting 

Certain Changes to an Approved 

Application; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: 

Recommendations for Blood 

Establishments: Training of Back-Up 

Personnel, Assessment of Blood Donor 

Suitability and Reporting Certain 

Changes to an Approved Application’’ 

dated November 2010. The guidance 

document provides recommendations to 

blood establishments for training of 

back-up personnel, assessment of blood 

donor suitability, and how to report 

certain changes to an approved license 

application to FDA. The guidance 

announced in this document finalizes 

the draft guidance entitled ‘‘Draft 

Guidance for Industry: 

Recommendations for the Assessment of 

Blood Donor Suitability, Blood Product 

Safety, and Preservation of the Blood 

Supply in Response to Pandemic 

(H1N1) 2009 Virus’’ dated November 

2009. The guidance announced in this 

document also is superseding certain 

recommendations in two previous 

guidances, the guidance document 

entitled ‘‘Guidance for Industry: 

Changes to an Approved Application: 

Biological Products: Human Blood and 

Blood Components Intended for 

Transfusion or for Further Manufacture’’ 

dated July 2001 and the guidance 

document entitled ‘‘Guidance for 

Industry: Streamlining the Donor 

Interview Process: Recommendations 

for Self-Administered Questionnaires’’ 

dated July 2003. 

DATES: Submit either electronic or 

written comments on agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist the 

office in processing your requests. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

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

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin A. Chacko, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Recommendations for Blood 

Establishments: Training of Back-Up 

Personnel, Assessment of Blood Donor 

Suitability and Reporting Certain 

Changes to an Approved Application’’ 

dated November 2010. The guidance 

document provides recommendations to 

blood establishments for training of 

back-up personnel, assessment of blood 

donor suitability, and reporting certain 

changes to an approved license 

application to FDA. 

In the Federal Register of November 

19, 2009 (74 FR 59982), FDA announced 

the availability of the draft guidance 

entitled ‘‘Draft Guidance for Industry: 

Recommendations for the Assessment of 

Blood Donor Suitability, Blood Product 

Safety, and Preservation of the Blood 

Supply in Response to Pandemic 

(H1N1) 2009 Virus’’ (November 2009). 

At that time, we anticipated that the 

rapid spread of pandemic (H1N1) 2009 

virus had the potential to cause 

disruptions in the blood supply and that 

the usual practices for ensuring blood 

availability in response to local disasters 

(i.e., hurricanes) would not be 

applicable or sufficient under a severe 

pandemic scenario. Since we issued the 

draft guidance, the H1N1 influenza 

pandemic has waned in the United 

States and disruptions in the blood 

supply have not been observed. 

Therefore, we are not finalizing those 

recommendations set forth in the draft 

guidance that referred to blood donor 

deferral and blood product management 

specific to the pandemic (H1N1) 2009 

virus. Instead, we are finalizing those 

recommendations contained in the draft 

guidance that are of general 

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75484 Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 

applicability (i.e., regardless of the 

existence of a pandemic or other 

emergency situation) as to training of 

back-up personnel, assessing blood 

donor suitability, and reporting certain 

changes to an approved application for 

licensed blood establishments. FDA 

received a few comments on the draft 

guidance in connection with these 

recommendations and those comments 

were considered as the guidance was 

finalized. In addition, editorial changes 

were made to improve clarity. The 

guidance announced in this document 

finalizes the draft guidance dated 

November 2009. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 606 have been approved 

under OMB control number 0910–0116. 

The collections of information for 21 

CFR part 601 have been approved under 

OMB control number 0910–0338. 

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 guidance at either 

http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: November 24, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30388 Filed 12–2–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, 

December 13, 2010, 8 a.m. to December 

13, 2010, 5 p.m., National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, 

MD 20892 which was published in the 

Federal Register on November 17, 2010, 

75 FR 70272–70273. 

The meeting will be held December 

17, 2010. The meeting time and location 

remain the same. The meeting is closed 

to the public. 

Dated: November 29, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30343 Filed 12–2–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel, 

Musculoskeletal and Skin Sciences. 

Date: December 13–14, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Rajiv Kumar, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

MSC 7802, Bethesda, MD 20892. 301–435– 

1212. kumarra@csr.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: Center for Scientific 

Review Special Emphasis Panel, Urology 

Small Business Applications. 

Date: December 14, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Ryan G. Morris, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4205, 

MSC 7814, Bethesda, MD 20892. 301–435– 

1501. morrisr@csr.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: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: HIV Pathogenesis, Therapy and 

NeuroAIDS. 

Date: December 15–16, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Shiv A Prasad, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5220, 

MSC 7852, Bethesda, MD 20892. 301–443– 

5779. prasads@csr.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. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: November 29, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30342 Filed 12–2–10; 8:45 am] 

BILLING CODE 4140–01–P 

mstockstill on DSKH9S0YB1PROD with NOTICES