Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 12311 

and B. Roerig & Co., then a division of 

Pfizer, that contained hydroxyzine 

hydrochloride and hydroxyzine 

pamoate (44 FR 6780, February 2, 1979) 

(the February 1979 Federal Register 

notice). Although some indications for 

these products were found to be 

supported by adequate and wellcontrolled clinical studies, other 

indications were determined to be 

lacking substantial evidence of 

effectiveness (Id.). The February 1979 

Federal Register notice offered an 

opportunity for hearing with respect to 

the indications found to be lacking 

substantial evidence of effectiveness, as 

well as with respect to any issues 

relating to the legal status of the drug 

products subject to it. 

In response to the February 1979 

Federal Register notice, Pfizer requested 

a hearing. No other companies 

requested a hearing. On November 22, 

2010, FDA sent a letter to Pfizer to 

determine whether Pfizer remained 

interested in pursuing its hearing 

request. On December 22, 2010, Pfizer 

responded by withdrawing its hearing 

request. There are no longer outstanding 

hearing requests pertaining to Docket 

No. FDA–1978–N–0441 (formerly 78N– 

0324). Therefore, shipment in interstate 

commerce of any product identified in 

this docket, or any IRS product, that is 

not the subject of an approved NDA or 

ANDA is unlawful as of the effective 

date of this notice. This notice is not 

applicable to OTC products that comply 

with an OTC monograph (21 CFR 

310.6(f)). Any person who wishes to 

determine whether a specific product is 

covered by this notice should write to 

the Center for Drug Evaluation and 

Research (see ADDRESSES). 

III. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the FD&C Act (21 U.S.C. 

360(j)). Other firms may discontinue 

manufacturing or marketing listed 

products in response to this notice. 

Firms that wish to notify the Agency of 

product discontinuation should send a 

letter, signed by the firm’s chief 

executive officer, fully identifying the 

discontinued product(s), including 

National Drug Code (NDC) number(s), 

and stating that the product(s) have 

been discontinued. The letter should be 

sent to Pamela Lee (see ADDRESSES). 

Firms should also update the listing 

of their products under section 510(j) of 

the FD&C Act to reflect discontinuation 

of unapproved products. FDA plans to 

rely on its existing records, including 

drug listing records or other available 

information, when it targets violations 

for enforcement action. Firms should be 

aware that after the effective date of this 

notice, FDA intends to take enforcement 

action without further notice against 

any firm that manufactures or ships in 

interstate commerce any unapproved 

product covered by this notice. 

IV. Reformulated Products 

FDA cautions firms against 

reformulating products into OTC 

products or different unapproved new 

drugs that are marketed under the same 

name or substantially the same name 

(including a new name that contains the 

old name). Reformulated products 

marketed under a name previously 

identified with a different active 

ingredient or combination of active 

ingredients have the potential to 

confuse health care practitioners and 

harm patients. 

This notice is issued under the FD&C 

Act (sections 502 and 505 (21 U.S.C. 352 

and 355)), and under authority 

delegated to the Deputy Commissioner 

for Policy under section 1410.10 of the 

FDA Staff Manual Guide. 

Dated: February 17, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–4781 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0024] 

Guidance for Industry on Size of Beads 

in Drug Products Labeled for Sprinkle; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Size of Beads in Drug Products 

Labeled for Sprinkle.’’ This guidance 

provides applicants preparing or 

submitting new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), and biologics 

licensing applications (BLAs) the Center 

for Drug Evaluation and Research’s 

(CDER’s) current thinking on 

appropriate size ranges for beads in drug 

products that are labeled to be 

administered via sprinkling (e.g., 

capsules or packets containing beads). 

In the Federal Register of January 19, 

2011 (76 FR 3144), FDA announced the 

availability of the draft version of this 

guidance. The public comment period 

closed on April 19, 2011. 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. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 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: 

Laurie Muldowney, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, rm. 

4154, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–1571. 

SUPPLEMENTARY INFORMATION:

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Size of 

Beads in Drug Products Labeled for 

Sprinkle.’’ This guidance provides 

applicants preparing or submitting 

NDAs, ANDAs, and BLAs CDER’s 

current thinking on appropriate size 

ranges for beads in drug products that 

are labeled to be administered via 

sprinkling (e.g., capsules or packets 

containing beads). 

Certain drug products that contain 

beads within a capsule indicate in the 

labeling that the capsule can be broken 

and the internal beads can be sprinkled 

on soft foods and swallowed without 

chewing as an alternative 

administration technique. This is 

particularly common with drug 

products designed to have extended- or 

delayed-release characteristics (i.e., the 

beads are manufactured to release the 

drug product at different rates). To make 

certain that the intended product 

performance is achieved—whether from 

a capsule that has been broken or from 


tkelley on DSK3SPTVN1PROD with NOTICES
12312 Federal Register / Vol. 77, No. 40 / Wednesday, February 29, 2012 / Notices 

a packet containing beads—it is 

important to have reasonable assurance 

that the patient will be able to swallow 

the beads (uncrushed) with the food 

with which the beads are mixed without 

stimulating the urge to chew. Additional 

assurances may be needed when the 

label also includes specific language 

concerning alternate administration via 

an enteral feeding tube. 

The recommendations in this 

guidance are based on literature on 

chewing and swallowing particle size 

and on Agency experience with NDAs 

and ANDAs submitted for these dosage 

forms. This guidance provides the 

following information related to drug 

products labeled for sprinkle: 

Appropriate maximum size for the 

beads, special considerations for 

sprinkle drug products that include 

language in labeling concerning 

alternate administration via an enteral 

feeding tube, and bioavailability (BA) or 

bioequivalence (BE) recommendations. 

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 the size of beads in 

drug products labeled for sprinkle. 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. 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 submitted in an 

NDA, ANDA, or BLA supporting the 

appropriate size for beads in drug 

products that are labeled to be 

administered via sprinkling, including 

related BA and BE studies, is approved 

by OMB under control number 0910– 

0001 for NDAs and ANDAs and control 

number 0910–0338 for BLAs. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http:// 

www.regulations.gov. 

Dated: February 23, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4784 Filed 2–28–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0130] 

Electronic Submission of Nonclinical 

Study Data; Notice of Pilot Project 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for 

Biologics Evaluation and Research 

(CBER) is announcing an invitation to 

participate in a pilot evaluation program 

to test the electronic submission of 

nonclinical study data using the 

Standard for Exchange of Nonclinical 

Data (SEND), a new electronic data 

standard format, which can be used to 

support review activity. Participation in 

the pilot program is open to all 

sponsors. The pilot program is intended 

to provide industry and CBER 

regulatory review staff the opportunity 

to evaluate SEND and determine if it 

facilitates the submission process of 

nonclinical study data related to 

investigational new drug applications 

(INDs). 

DATES: Submit either electronic or 

written requests for participation in this 

pilot program by May 29, 2012. 

ADDRESSES: Submit electronic requests 

to participate in the pilot and comments 

regarding the project to http:// 

www.regulations.gov. Submit written 

requests and 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: 

Amy Malla, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6085, email: 

Amy.Malla@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products and is committed to advancing 

the public health through innovative 

activities that help ensure the safety, 

effectiveness and timely delivery of 

these products to patients. Further, 

CBER seeks to continuously enhance 

and update review efficiency and 

quality, and the quality of its regulatory 

efforts and interactions, by providing 

CBER staff and industry with improved 

processes. In support of this goal, CBER 

has participated in the development of 

the Clinical Data Interchange Standards 

Consortium (CDISC) SEND, a data 

model initially developed for 

nonclinical data from animal studies 

submitted in support of applications for 

approval of human drugs. This pilot is 

designed to test the ability of SEND to 

support the review of nonclinical study 

data submitted to CBER. The ultimate 

goal of the pilot is to replace the existing 

paper and portable document format 

(PDF)-based listings of nonclinical study 

data. 

SEND was developed by the CDISC 

SEND Team. CDISC is an open, 

multidisciplinary, nonprofit 

organization that has established 

worldwide industry standards to 

support the electronic acquisition, 

exchange, submission, and archiving of 

clinical trial data and metadata for 

medical and biopharmaceutical product 

development (http://www.cdisc.org). 

Where possible, the standards 

developed for clinical datasets and 

metadata, as described in the overall 

Study Data Tabulation Model (SDTM), 

are being used to develop a 

standardized format for nonclinical 

studies. 

Recently, CBER has adopted a 

standard for clinical study data based on 

the CDISC SDTM standard. FDA 

believes the use of standardized SEND 

datasets, together with new and better 

analysis tools, will enhance CBER’s 

review and evaluation of nonclinical 

data. 

The Center for Drug Evaluation and 

Research (CDER) completed a pilot 

project (phase 1) using the SEND format 

in sample nonclinical datasets, that is 

outside of a regulatory setting (68 FR 

3885, January 27, 2003). The phase 1 

CDER pilot also evaluated data 

validation and analysis tools 

specifically designed to validate 

datasets according to the current SEND 

standard and to enable a reviewer to 

display and evaluate data efficiently 


tkelley on DSK3SPTVN1PROD with NOTICES