51040 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 

for CDER (35 FR 3685, February 25, 

1970; 60 FR 56605, November 9, 1995; 

64 FR 36361, July 6, 1999; 72 FR 50112, 

August 30, 2007; and 76 FR 19376, 

April 7, 2011) is amended to reflect the 

restructuring of CDER that was 

approved by the Secretary of Health and 

Human Services on May 25, 2011. This 

reorganization is explained in Staff 

Manual Guide 1264.31, 1264.36, 

1264.37, 1264.38, and 1264.39, and 

includes the establishment of the 

Division of Bioequivalence II, Division 

of Microbiology, Division of Clinical 

Review, and Division of Chemistry IV. 

In addition, CDER is retitling the 

Division of Bioequivalence to the 

Division of Bioequivalence I. 

II. Delegation of Authority 

Pending further delegation, directives 

or orders by the Commissioner of Food 

and Drugs or the Center Director, CDER, 

all delegations and redelegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

III. Electronic Access 

Person interested in seeing the 

complete Staff Manual Guide can find it 

on FDA’s Web site at http:// 

www.fda.gov/AboutFDA/ 

ReportsManualsForms/ 

StaffManualGuides/default.htm. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20859 Filed 8–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Food and Drug Administration Clinical 

Trial Requirements, Regulations, 

Compliance, and Good Clinical 

Practice; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) Philadelphia District Office, in 

co-sponsorship with the Society of 

Clinical Research Associates (SoCRA) is 

announcing a public workshop. The 

public workshop on FDA’s clinical trial 

requirements is designed to aid the 

clinical research professional’s 

understanding of the mission, 

responsibilities, and authority of FDA 

and to facilitate interaction with FDA 

representatives. The program will focus 

on the relationships among FDA and 

clinical trial staff, investigators, and 

institutional review boards (IRB). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices, 

and biologics; as well as inspections of 

clinical investigators, IRB, and research 

sponsors. 

Date and Time: The public workshop 

will be held on November 16 and 17, 

2011, from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Sheraton Philadelphia 

City Center Hotel, 201 North 17th St., 

Philadelphia, PA 19103, 1–215–448– 

2000. 

Attendees are responsible for their 

own accommodations. Please mention 

SoCRA to receive the hotel room rate of 

$159 plus applicable taxes (available 

until November 1, 2011, or until the 

SoCRA room block is filled). 

Contact: Anne Johnson, Food and 

Drug Administration, Philadelphia 

District, 900 U.S. Customhouse, Second 

& Chestnut Streets, Philadelphia, PA 

19106, 215–597–4390, FAX: 215–597– 

4660, e-mail: anne.johnson@fda.hhs.

gov; or Society of Clinical Research 

Associates (SoCRA), 530 West Butler 

Ave., suite 109, Chalfont, PA 18914, 1– 

800–762–7292 or 215–822–8644, FAX: 

215–822–8633, e-mail: SoCRAmail@aol.

com, Web site: http://www.SoCRA.org. 

(FDA has verified the Web site 

addresses throughout this document, 

but we are not responsible for any 

subsequent changes to the Web sites 

after this document publishes in the 

Federal Register.) 

Registration: The registration fee 

covers the cost of actual expenses, 

including refreshments, lunch, 

materials, and speaker expenses. Seats 

are limited; please submit your 

registration as soon as possible. 

Workshop space will be filled in order 

of receipt of registration. Those accepted 

into the workshop will receive 

confirmation. The cost of registration is 

as follows: 

COST OF REGISTRATION

SoCRA member .................................................................................................... ($575.00) 

SoCRA nonmember (includes membership) ......................................................... ($650.00) 

Federal Government member ............................................................................... ($450.00) 

Federal Government nonmember ......................................................................... ($525.00) 

FDA Employee ...................................................................................................... (free) Fee Waived 

If you need special accommodations 

due to a disability, please contact 

SoCRA (see Contact) at least 21 days in 

advance. 

Extended periods of question and 

answer and discussion have been 

included in the program schedule. 

SoCRA designates this educational 

activity for a maximum of 13.3 

Continuing Education Credits for 

SoCRA CE and Nurse CNE. SOCRA 

designates this live activity for a 

maximum of 13.3 AMA PRA Category 1 

Credit(s) TM. Physicians should claim 

only the credit commensurate with the 

extent of their participation. CME for 

Physicians: SoCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide 

continuing medical education for 

physicians. CNE for Nurses: SoCRA is 

an approved provider of continuing 

nursing education by the Pennsylvania 

State Nurses Association (PSNA), an 

accredited approver by the American 

Nurses Credentialing Center’s 

Commission on Accreditation (ANCC). 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and e-mail, 

along with a check or money order 

payable to ‘‘SoCRA’’. Mail to: SoCRA 

(see Contact for address). To register via 

the Internet, go to http://www.socra.org/ 

html/FDA_Conference.htm. Payment by 

major credit card is accepted (Visa/ 

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SoCRA (see Contacts). 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 51041 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, IRB inspections, 

electronic record requirements, and 

investigator initiated research. Topics 

for discussion include the following: (1) 

What FDA Expects in a Pharmaceutical 

Clinical Trial; (2) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (3) Part 11 Compliance— 

Electronic Signatures; (4) Informed 

Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

With FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working With FDA’s 

Center for Biologics Evaluation and 

Research; (12) The Inspection is Over— 

What Happens Next? Possible FDA 

Compliance Actions; (13) Ethical Issues 

in Subject Enrollment; (14) Medical 

Device Aspects of Clinical Research); 

(15) Are We There Yet? An Overview of 

the FDA GCP Program. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Pub. L. 104–121) as outreach 

activities by Government Agencies to 

small businesses. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20858 Filed 8–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Hemoglobin Standards and 

Maintaining Adequate Iron Stores in 

Blood Donors; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: ‘‘Hemoglobin Standards and 

Maintaining Adequate Iron Stores in 

Blood Donors.’’ The purpose of this 

public workshop is to discuss blood 

donor hemoglobin and hematocrit 

qualification standards in the United 

States, its impact on donor safety and 

blood availability, and potential 

measures to maintain adequate iron 

stores in blood donors. The public 

workshop has been planned in 

partnership with the Department of 

Health and Human Services (HHS) 

Office of the Assistant Secretary for 

Health, the National Heart, Lung and 

Blood Institute, America’s Blood 

Centers, AABB, and the Plasma Protein 

Therapeutics Association. This public 

workshop will include presentations 

and panel discussions by experts 

knowledgeable in the field from 

academic institutions, government 

agencies, and industry. 

Dates and Times: The public 

workshop will be held on November 8, 

2011, from 8 a.m. to 5:30 p.m. and 

November 9, 2011, from 8 a.m. to 3 p.m. 

Location: The public workshop will 

be held at the Natcher Conference 

Center, Main Auditorium, Building 45, 

National Institutes of Health, 45 Center 

Dr., Bethesda, MD 20892. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, 

e-mail: rhonda.dawson@fda.hhs.gov. 

Registration: Mail, fax, or email your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to Rhonda 

Dawson (see Contact Person) by October 

14, 2011. There is no registration fee for 

the public workshop. Early registration 

is recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 

7:30 a.m. 

If you need special accommodations 

due to a disability, please contact 

Rhonda Dawson (see Contact Person) at 

least 7 days in advance. 

SUPPLEMENTARY INFORMATION: 

Under FDA’s current regulations, 

allogeneic blood donors must have a 

hemoglobin level of no less than 12.5 

grams of hemoglobin per 100 milliliters 

of blood or a hematocrit value of 38 

percent prior to donation (21 CFR 

640.3(b)(3) and 640.63(c)(3)). 

Hemoglobin and hematocrit 

measurements are typically obtained 

from a small sample of blood drawn 

from a finger or vein. New technologies 

that potentially allow for less invasive, 

faster, and more convenient methods of 

measuring blood donor hemoglobin and 

hematocrit levels are being studied. A 

low donor hemoglobin and hematocrit 

level is the most common reason that 

prospective blood donors, particularly 

women, are deferred. 

Allogeneic donors of a unit of red 

blood cells generally may not donate 

more than once in an 8 week period to 

ensure recovery of their red blood cells 

and iron stores (21 CFR 640.3). 

Nonetheless, some donors, especially 

repeat and premenopausal female 

donors, can develop iron deficiency, 

with or without anemia, from blood 

donation. Improved understanding of 

iron loss in blood donors may help 

reduce donor deferrals due to low 

hemoglobin and hematocrit levels and 

reduce iron deficiency that can result 

from blood donation. Different strategies 

to minimize iron deficiency in blood 

donors (e.g., testing for iron stores, 

adjusting the donation interval, or 

providing iron replacement) have been 

explored in the past. Changes in 

qualifying hemoglobin levels have been 

discussed in various forums for both 

men and women to bring these levels 

into closer concordance with population 

norms. However, the potential risks and 

benefits of these strategies require 

further discussion. 

This public workshop will serve as a 

forum for discussion of hemoglobin and 

hematocrit donation standards, current 

methods for hemoglobin measurement, 

iron loss and iron measurement 

methods in blood donors, and strategies 

to maintain adequate donor iron stores. 

The first day of the public workshop 

will include presentations and panel 

discussions on the following topics: (1) 

Hemoglobin standards for blood donors 

in the United States; (2) studies of 

hemoglobin distribution and deferral 

patterns in blood donors; and (3) 

measurement of hemoglobin and 

hematocrit and iron levels in blood 

donors. The second day of the public 

workshop will include a discussion of 

the following topics: (1) Iron 


Emcdonald on DSK2BSOYB1PROD with NOTICES