Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11545 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual 

Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Total 

Capital 

Costs 

Total Operating 

& Maintenance 

Costs 

900.3(f)(1) 0 .1 1 0 .1 0 0 

900.4(g) 5 1 5 1 5 

900.12(a)(1)(i)(B)(2) 87 1 87 8 696 

900.12(a)(4) 8,681 4 34,724 1 34,724 

900.12(c)(4) 8,681 1 8,681 1 8,681 $28,000 

900.12(e)(13) 8,681 52 451,412 .083333 37,618 

900.12(f) 8,681 1 8,681 16 138,896 

900.12(h)(2) 8,681 2 17,362 1 17,362 

900.22(a) 5 1 5 1 5 

900.22(d) 5 1 5 1 5 

900.22(e) 5 1 5 1 5 

900.22(f) 3 1 3 1 3 

900.22(g) 5 1 5 1 5 $50 

900.25(b) 5 1 5 1 5 

Total 238,010 $28,000 $50 

The following sections of title 21 of 

the Code of Federal Regulations (CFR) 

were not included in the previously 

mentioned burden tables because they 

were considered usual and customary 

practice and were part of the standard 

of care prior to the implementation of 

the regulations. Therefore, they resulted 

in no additional reporting or 

recordkeeping burden: 21 CFR 

900.12(c)(1) and (c)(3) and 21 CFR 

900.3(f)(1). 

Section 900.3(c) was not included in 

the previously mentioned burden tables 

because all four existing accreditation 

bodies are approved until late in 2013; 

so, no applicants will reapply during 

the requested information collection 

period. Section 900.24(c) was also not 

included in the previously mentioned 

burden tables because if a certifying 

state had its approval withdrawn, FDA 

would take over certifying authority for 

the affected facilities. Because FDA 

already has all the certifying state’s 

electronic records, there wouldn’t be an 

additional reporting burden. 

Dated: March 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–5230 Filed 3–11–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0101] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Human Cells, 

Tissues, and Cellular and TissueBased Products: Establishment 

Registration and Listing; Form FDA 

3356; Eligibility Determination for 

Donors; and Current Good Tissue 

Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection requirements 

for FDA regulations related to human 

cells, tissues, and cellular and tissuebased products (HCT/Ps) involving 

establishment registration and listing 

using Form FDA 3356; eligibility 

determination for donors; and current 

good tissue practice (CGTP). 

DATES: Submit written or electronic 

comments on the collection of 

information by May 10, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 


jlentini on DSKJ8SOYB1PROD with NOTICES
11546 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products: Establishment 

Registration and Listing; Form FDA 

3356; Eligibility Determination for 

Donors; and Current Good Tissue 

Practice—(OMB Control Number 0910– 

0543)—Extension 

Under section 361 of the Public 

Health Service Act (the PHS Act) (42 

U.S.C. 264), FDA may issue and enforce 

regulations necessary to prevent the 

introduction, transmission, or spread of 

communicable diseases between the 

States or possessions or from foreign 

countries into the States. As derivatives 

of the human body, all HCT/Ps pose 

some risk of carrying pathogens that 

could potentially infect recipients or 

handlers. FDA has issued regulations 

related to HCT/Ps involving 

establishment registration and listing 

using Form FDA 3356, eligibility 

determination for donors, and CGTP. 

A. Establishment Registration and 

Listing; Form FDA 3356 

The regulations in part 1271 (21 CFR 

part 1271) require domestic and foreign 

establishments that recover, process, 

store, label, package, or distribute an 

HCT/P described in § 1271.10(a), or that 

perform screening or testing of the cell 

or tissue donor to register with FDA 

(§ 1271.10(b)(1)) and submit a list of 

each HCT/P manufactured 

(§ 1271.10(b)). Section 1271.21(a) 

requires an establishment to follow 

certain procedures for initial registration 

and listing of HCT/Ps, and § 1271.25(a) 

and (b) identifies the required initial 

registration and HCT/P listing 

information. Section 1271.21(b), in 

brief, requires an annual update of the 

establishment registration. Section 

1271.21(c)(ii) requires establishments to 

submit HCT/P listing updates when an 

HCT/P is changed as described in 

§ 1271.25(c). Section 1271.25(c) 

identifies the required HCT/P listing 

update information. Section 1271.26 

requires establishments to submit an 

amendment if ownership or location of 

the establishment changes. FDA 

requires the use of a registration and 

listing form (Form FDA 3356: 

Establishment Registration and Listing 

for Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps)) to 

submit the required information 

(§§ 1271.10, 1271.21, 1271.25, and 

1271.26). To further facilitate the ease 

and speed of submissions, electronic 

submission is accepted (http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/EstablishmentRegistration/ 

TissueEstablishmentRegistration/ 

default.htm). 

B. Eligibility Determination for Donors 

In brief, FDA requires certain HCT/P 

establishments described in § 1271.1(b) 

to determine donor eligibility based on 

donor screening and testing for relevant 

communicable diseases agents and 

diseases, except as provided under 

§ 1271.90. The documented 

determination of a donor’s eligibility is 

made by a responsible person defined in 

§ 1271.3(t) and is based on the results of 

required donor screening, which 

includes a donor medical history 

interview (defined in § 1271.3(n)) and 

testing (§ 1271.50(a)). Certain records 

must accompany an HCT/P once the 

donor-eligibility determination has been 

made (§ 1271.55(a)). This requirement 

applies both to an HCT/P from a donor 

who is determined to be eligible as well 

as to an HCT/P from a donor who is 

determined to be ineligible or where the 

donor-eligibility determination is not 

complete if there is a documented 

urgent medical need (§ 1271.60). Once 

the donor-eligibility determination has 

been made, the HCT/P must be 

accompanied by a summary of records 

used to make the donor-eligibility 

determination (§ 1271.55(b)) and a 

statement whether, based on the results 

of the screening and testing, the donor 

is determined to be eligible or ineligible 

(§ 1271.55(a)(2)). 

Records used in determining the 

eligibility of a donor, i.e., results and 

interpretations of testing for relevant 

communicable disease agents, the 

donor-eligibility determination, the 

name and address of the testing 

laboratory or laboratories, and the name 

of the responsible person (defined in 

§ 1271.3(t)) who made the donoreligibility determination and the date of 

the determination, must be maintained 

(§ 1271.55(d)(1)). If any information on 

the donor is not in English, the original 

record must be retained and translated 

to English and accompanied by a 

statement of authenticity from the 

translator (§ 1271.55(d)(2)). HCT/P 

establishments must retain the records 

pertaining to HCT/Ps at least 10 years 

after the date of administration, 

distribution, disposition, or expiration, 

whichever is latest (§ 1271.55(d)(4)). 

When a product is shipped in 

quarantine as defined in § 1271.3(q), 

before completion of screening and 

testing, the HCT/P must be 

accompanied by records identifying the 

donor; stating that the donor-eligibility 

determination has not been completed; 

and stating that the product must not be 

used until the donor-eligibility 

determination has been completed 

(§ 1271.60(c)). When an HCT/P is used 

in cases of documented urgent medical 

need, the results of any completed 

donor screening and testing, and a list 

of any required screening and testing 

not yet completed also must accompany 

the HCT/P (§ 1271.60(d)(2)). When an 

HCT/P is used in cases of urgent 

medical need or from a donor who has 

been determined to be ineligible (as 

permitted under § 1271.65), 

documentation by the HCT/P 

establishment is required showing that 

the recipient’s physician received 

notification that the testing and 

screening were not complete (in cases of 

urgent medical need), and upon the 

completion of the donor-eligibility 

determination, of the results of the 

determination (§ 1271.60(d)(3) and 

(d)(4) and § 1271.65(b)(3)). 

An HCT/P establishment is also 

required to establish and maintain 

procedures for all steps that are 

performed in determining eligibility 

(§ 1271.47(a)), including the use of a 

product from a donor testing reactive for 

cytomegalovirus (§ 1271.85(b)(2)). The 

HCT/P establishment must record any 

departure from the procedures 

(§ 1271.47(d)). 

C. Current Good Tissue Practice (CGTP) 

FDA requires certain HCT/P 

establishments to follow CGTP 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11547 

(§ 1271.1(b)). Section 1271.155(a) 

permits the submission of a request for 

FDA approval of an exemption from or 

alternative to any requirement in 

subpart C or D of part 1271. Section 

1271.290(c) requires such 

establishments to affix a distinct 

identification code to each HCT/P that 

it manufactures that relates the HCT/P 

to the donor and to all records 

pertaining to the HCT/P. Whenever an 

establishment distributes an HCT/P to a 

consignee, § 1271.290(f) requires the 

establishment to inform the consignee, 

in writing, of the product tracking 

requirements and the methods the 

establishment uses to fulfill the 

requirements. Non-reproductive HCT/P 

establishments described in § 1271.10 

are required under §§ 1271.350(a)(1) and 

(a)(3) to investigate and report to FDA 

adverse reactions (defined in 

§ 1271.3(y)) using Form FDA–3500A 

(§ 1271.350(a)(2)). Form FDA–3500A is 

approved under OMB Control No. 0910– 

0291. Section 1271.370(b) and (c) 

requires establishments to include 

specific information either on the 

HCT/P label or with the HCT/P. 

The standard operating procedures 

(SOP) provisions under part 1271 

include the following: (1) Section 

1271.160(b)(2) (receiving, investigation, 

evaluating, and documenting 

information relating to core CGTP 

requirements, including complaints, 

and for sharing information with 

consignees and other establishments); 

(2) § 1271.180(a) (to meet core CGTP 

requirements for all steps performed in 

the manufacture of HCT/Ps); (3) 

§ 1271.190(d)(1) (facility cleaning and 

sanitization); (4) § 1271.200(b) (cleaning, 

sanitizing, and maintenance of 

equipment); (5) § 1271.200(c) 

(calibration of equipment); (6) 

§ 1271.230(a) and (c) (validation of 

changes to a process); (7) § 1271.250(a) 

(controls for labeling HCT/Ps); (8) 

§ 1271.265(e) (receipt, predistribution 

shipment, availability for distribution, 

and packaging and shipping of HCT/Ps); 

(9) § 1271.265(f) (suitable for return to 

inventory); (10) § 1271.270(b) (records 

management system); (11) 

§ 1271.290(b)(1) (system of HCT/P 

tracking); and (12) § 1271.320(a) 

(review, evaluation, and documentation 

of complaints (as defined in 

§ 1271.3(aa))). 

Section 1271.155(f) requires an 

establishment operating under the terms 

of an exemption or alternative to 

maintain documentation of the terms 

and date of FDA approval. Section 

1271.160(b)(3) requires documentation 

of appropriate corrective actions taken 

as a result of an audit of the quality 

program. Section 1271.160(b)(6) 

requires documentation of HCT/P 

deviations. Section 1271.160(d) requires 

documentation of computer validation 

or verification activities and results 

when computers are used to comply 

with the core CGTP requirements for its 

intended use. Section 1271.190(d)(2) 

requires documentation of all facility 

cleaning and sanitation activities 

performed to prevent contamination of 

HCT/Ps. Section 1271.195(d) requires 

documentation of environmental control 

and monitoring activities. Section 

1271.200(e) requires documentation of 

equipment maintenance, cleaning, 

sanitizing, calibration, and other 

activities. Section 1271.210(d) requires 

documentation of the receipt, 

verification, and use of each supply or 

reagent. Section 1271.230(a) requires 

documentation of validation activities 

when the results of a process cannot be 

fully verified by subsequent inspection 

and tests. Section 1271.230(c) requires 

documentation of the review and 

evaluation of a process and revalidation 

of the process, if necessary, when any 

changes to a validated process occur. 

Section 1271.260(d) and (e) requires 

documentation of any corrective action 

taken when proper storage conditions 

are not met and documentation of 

storage temperatures for HCT/Ps. 

Section 1271.265(c)(1) requires 

documentation that release criteria have 

been met before distribution of an 

HCT/P. Section 1271.265(c)(3) requires 

documentation of any departure from a 

procedure at the time of its occurrence. 

Section 1271.265(e) requires 

documentation of the receipt, 

predistribution shipment, distribution, 

and packaging and shipping of HCT/Ps. 

Section 1271.270(a) requires 

documentation of each step in 

manufacturing required in part 1271, 

subparts C and D. Section 1271.270(e) 

requires documentation of the name and 

address, and a list of responsibilities of 

any establishment that performs a 

manufacturing step for an 

establishment. Sections 1271.290(d) and 

(e) require documentation of a method 

for recording the distinct identification 

code and type of each HCT/P 

distributed to a consignee to enable 

tracking from the consignee to the donor 

and to enable tracking from the donor to 

the consignee or final disposition. 

Section 1271.320(b) requires an 

establishment to maintain a record of 

each complaint that it receives, that 

contains relevant information for proper 

review and evaluation. 

Respondents to this information 

collection are establishments that 

recover, process, store, label, package, or 

distribute any HCT/P, or perform donor 

screening or testing. The estimates 

provided below are based on the most 

recent available information from FDA’s 

database system and trade 

organizations. The hours per response 

and hours per record are based on data 

provided by the Eastern Research 

Group, or FDA experience with similar 

recordkeeping or reporting 

requirements. 

There are an estimated 2,281 HCT/P 

establishments (conventional tissue, eye 

tissue, peripheral blood stem cell, stem 

cell products from cord blood, 

reproductive tissue, and sperm banks), 

including 692 manufacturers of HCT/P 

products regulated under the Federal 

Food, Drug, and Cosmetics Act and 

section 351 of the PHS Act (42 U.S.C. 

262), that have registered and listed 

with FDA. In addition, we estimate that 

251 new establishments have registered 

with FDA (§ 1271.10(b)(1) and (b)(2) and 

§ 1271.25(a) and (b)). There are an 

estimated 2,230 listing updates 

(§§ 1271.10(b)(2), 1271.21(c)(ii), and 

1271.25(c)) and 565 location/ownership 

amendments (§ 1271.26). 

Under § 1271.55(a), an estimated total 

of 2,167,396 HCT/Ps (which include 

conventional tissues, eye tissues, 

hematopoetic stem cells/progenitor 

cells, and reproductive cells and tissues) 

and an estimated total of 2,026,024 nonreproductive cells and tissues (total 

HCT/Ps minus reproductive cells and 

tissues) are distributed per year by an 

estimated 1,589 establishments (2,281 - 

692 = 1,589 establishments with 

approved applications). 

Under § 1271.60(c) and (d)(2), FDA 

estimates that 1,375 establishments 

shipped an estimated 286,000 HCT/Ps 

under quarantine, and that an estimated 

18 establishments requested an 

exemption from or alternative to any 

requirement under part 1271, subpart C 

or D, specifically under § 1271.155(a). 

Under § 1271.290(c) and § 1271.370(b) 

and (c), an estimated 1,694 nonreproductive HCT/P establishments 

label each of their 2,026,024 HCT/Ps 

with certain information. These 

establishments are also required to 

inform their consignees in writing of the 

requirements for tracking and of their 

established tracking system under 

§ 1271.290(f). 

FDA estimates 38 HCT/P 

establishments submitted 76 adverse 

reaction reports involving a 

communicable disease 

(§ 1271.350(a)(1)). 

FDA estimates that 251 new 

establishments will create SOPs, and 

that 2,281 establishments will review 

and revise existing SOPs annually. 

FDA estimates that 1,141 HCT/P 

establishments (2,281 x 50% = 1,141) 


jlentini on DSKJ8SOYB1PROD with NOTICES
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and 847 non-reproductive HCT/P 

establishments (1,694 x 50% = 847) 

record and justify a departure from the 

procedures (§§ 1271.47(d) and 

1271.265(c)(3)). 

Under § 1271.50(a), HCT/P 

establishments are required to have a 

documented medical history interview 

about the donor’s medical history and 

relevant social behavior as part of the 

donor’s relevant medical records for 

each of the estimated total of 91,240 

donors (which include conventional 

tissue donors, eye tissue donors, 

peripheral and cord blood stem cell 

donors, and reproductive cell and tissue 

donors), and the estimated total of 

86,394 non-reproductive cells and tissue 

donors (total donors minus reproductive 

cell and tissue donors). 

FDA estimates that 684 HCT/P 

establishments (2,281 x 30% = 684) 

document an urgent medical need for an 

HCT/P and notify the physician using 

the HCT/P (§ 1271.60(d)(3) and (d)(4) 

and § 1271.65(b)(3)(iii)). 

FDA also estimates that 1,824 HCT/P 

establishments (2,281 x 80% = 1,824) 

have to maintain records for an average 

of 2 contract establishments that 

perform a manufacturing process step 

for them (§ 1271.270(e)) and 1,141 

HCT/P establishments maintain an 

average of 5 complaint records annually 

(§ 1271.320(b)). 

In some cases, the estimated burden 

may appear to be lower or higher than 

the burden experienced by individual 

establishments. The estimated burden in 

these charts is an estimated average 

burden, taking into account the range of 

impact each regulation may have. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1271.10(b)(1) and 1271.21(b)2 2,281 1 2,281 .5 1,141 

1271.10(b)(1) and (b)(2), 

1271.21(a), and 1271.25(a) and 

(b)2 251 1 251 .75 188 

1271.10(b)(2), 1271.21(c)(2)(ii), and 

1271.25(c)2 2,230 1 2,230 .5 1,115 

1271.262 565 1 565 .25 141 

1271.55(a) 1,589 1,364 2,167,396 .5 1,083,698 

1271.60(c) and (d)(2) 1,375 208 286,000 .5 143,000 

1271.155(a) 18 1 18 3 54 

1271.290(c) 1,694 1,196 2,026,024 .083 168,835 

1271.290(f) 1,694 1 1,694 1 1,694 

1271.350(a)(1) and (a)(3) 38 2 76 1 76 

1271.370(b) and (c) 1,694 1,196 2,026,024 .25 506,506 

Total 1,906,448 

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

2 Using Form FDA 3356. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

New SOPs2 251 1 251 48 12,048 

SOP Update2 2,281 1 2,281 24 54,744 

1271.47(d) 1,141 1 1,141 1 1,141 

1271.50(a) 2,281 40 91,240 5 456,200 

1271.55(d)(1) 2,281 40 91,240 1 91,240 

1271.55(d)(2) 2,281 1 2,281 1 2,281 

1271.55(d)(4) 2,281 1 2,281 120 273,720 

1271.60(d)(3) and (d)(4), and 

1271.65(b)(3)(iii) 684 1 684 2 1,368 

1271.155(f) 18 1 18 .25 5 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11549 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1271.160(b)(3) and (b)(6) 1,694 12 20,328 1 20,328 

1271.160(d) 1,694 12 20,328 1 20,328 

1271.190(d)(2) 1,694 12 20,328 1 20,328 

1271.195(d) 1,694 12 20,328 1 20,328 

1271.200(e) 1,694 12 20,328 1 20,328 

1271.210(d) 1,694 12 20,328 1 20,328 

1271.230(a) 1,694 12 20,328 1 20,328 

1271.230(c) 1,694 1 1,694 1 1,694 

1271.260(d) 1,694 12 20,328 .25 5,082 

1271.260(e) 1,694 365 618,310 .083 51,526 

1271.265(c)(1) 1,694 1,196 2,026,024 .083 168,835 

1271.265(c)(3) 847 1 847 1 847 

1271.265(e) 1,694 1,196 2,026,024 .083 168,835 

1271.270(a) 1,694 1,196 2,026,024 .25 506,506 

1271.270(e) 1,824 2 3,648 .5 1,824 

1271.290(d) and (e) 1,694 51 86,394 .25 21,599 

1271.320(b) 1,141 5 5,705 1 5,705 

Total 1,967,496 

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

2Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 

1271.250(a), and 1271.265(e). 

Dated: March 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–5229 Filed 3–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0109] 

Determination That PRO–BANTHINE 

(Propantheline Bromide) Tablets and 

14 Other Drug Products Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that the 15 drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’ 

which is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(j)(7)), which requires 

FDA to publish a list of all approved 

drugs. FDA publishes this list as part of 

the ‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is withdrawn from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness, or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 


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