Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 51039 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Residual Drug in Transdermal and 

Related Drug Delivery Systems.’’ This 

guidance provides recommendations to 

developers and manufacturers of TDDS, 

TMDS, and topical patch products 

regarding use of an appropriate 

scientific approach during product 

design and development—as well as 

during manufacturing and product lifecycle management—to ensure that the 

amount of residual drug substance at the 

end of the labeled use period is 

minimized. In the Federal Register of 

August 3, 2010 (75 FR 45640), FDA 

announced the availability of the draft 

version of this guidance. The public 

comment period closed on November 1, 

2010. A number of comments were 

received from the public, all of which 

the Agency considered carefully as it 

finalized the guidance and made 

appropriate changes. Any changes to the 

guidance were minor and made to 

clarify statements in the draft guidance. 

Existing TDDS, TMDS, and topical 

patches contain a larger amount of the 

drug substance than what is intended to 

be delivered to the patient. This excess 

amount of drug substance is needed to 

facilitate delivery of the intended 

amount of the drug to the patient and 

remains as residual drug in the used 

system. The amount of residual drug 

substance in TDDS, TMDS, and topical 

patches has a significant potential to 

impact the products’ quality, efficacy, 

and safety (including abuse potential). 

Consequently, it is necessary to ensure 

that an appropriate scientific approach 

is used to design and develop these 

products. The approach should ensure 

that the amount of residual drug 

substance is minimized consistent with 

the current state of technology. 

Currently marketed TDDS, TMDS, 

and topical patches may retain 10 to 95 

percent of the initial total amount of 

drug as the residual drug after the 

intended use period. This raises a 

potential safety issue not only to the 

patient, but also to others, including 

family members, caregivers, children, 

and pets. For example, adverse events 

due to a patient’s failure to remove 

TDDS at the end of the intended use 

period have been reported and are 

generally related to an increased or 

prolonged pharmacological effect of the 

drug. Also, some children have died 

from inadvertent exposure to discarded 

TDDS. Reported adverse events 

resulting from various quality problems 

pertaining to TDDS have lead to product 

recalls, withdrawals, and public health 

advisories. 

To reduce some of these risks, the 

Agency recommends that a robust 

design and development approach be 

considered when developing and 

manufacturing TDDS, TMDS, and 

topical patches. One example of such an 

approach is quality by design, as 

described in the International 

Conference on Harmonization guidance 

for industry entitled ‘‘Q8(R2) 

Pharmaceutical Development.’’ The 

Agency also recommends that sufficient 

scientific justification to support the 

amount of residual drug in TDDS, 

TMDS, or topical patches be included in 

an application. The justification should 

include an evaluation of the safety risks 

involved with the formulation and 

system design, as well as support the 

amount of drug load in the TDDS, 

TMDS, or topical patch based on the 

proposed quality target product profile 

and formulation studies. Most 

important, the justification for 

applications of products with known 

safety issues—such as those with 

fentanyl-containing liquid reservoir 

systems—should demonstrate that the 

safety risk factors have been adequately 

mitigated. 

In all cases, the level of information 

in the justification should be sufficient 

to demonstrate product and process 

understanding and ensure that a 

scientific, risk-based approach has been 

taken to minimize the amount of 

residual drug in a system after use to the 

lowest possible level. It is expected that 

the amount of residual drug in a newly 

developed system (including new 

generic drug products) will not exceed 

that of similar FDA-approved products. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on residual drug in 

transdermal and related drug delivery 

systems. 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. 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. 

III. The 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). Information in an application on 

the product and process development 

and justification for the final 

formulation and system design is 

approved under OMB control numbers 

0910–0001 and 0910–0014. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20852 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–0013] 

Statement of Organizations, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that it has reorganized the Center for 

Drug Evaluation and Research (CDER) 

by establishing four new Divisions 

under the Office of Generic Drugs. This 

reorganization includes the organization 

and their substructure components as 

listed in this document. This document 

is announcing the availability of the 

Staff Manual Guide that explains the 

details of this reorganization. 

FOR FURTHER INFORMATION CONTACT: 

Karen Koenick, Center for Drug 

Evaluation and Research (HFD–063), 

Food and Drug Administration, 1919 

Rockville Pike, Rm. 324, Rockville, MD 

20852, 301–796–4422. 

SUPPLEMENTARY INFORMATION: 

I. Summary 

The Statement of Organization, 

Functions, and Delegations of Authority 


Emcdonald on DSK2BSOYB1PROD with NOTICES
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