906 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

trigger approximately 186 efficacy 

supplements, each one requiring 

approximately 196 hours to revise the 

labeling in the application, totaling 

36,456 hours. (As stated in the final 

rule, in addition to this burden, a 

minimal annual reporting burden (fewer 

than 7) will continue indefinitely). 

Burden Associated with Revised 

Labeling for Efficacy Supplements for 

Generic Drug Products (§ 201.57) (Table 

2) 

Based on the projected data estimated 

in the final rule, beginning in year 3 and 

continuing throughout the 10-year 

period analyzed, approximately 42 

generic applicants per year must submit 

labeling supplements. Approximately 

336 already approved generic drug 

applications must submit labeling 

supplements over the 10-year period 

after the effective date of the rule. The 

time required to revise and submit this 

labeling to FDA is approximately 27 

hours per application, totaling 9,072 

hours. (As stated in the final rule, in 

addition to this burden, a minimal 

annual reporting burden associated with 

a very small number of generic 

applications referencing older drugs 

may continue indefinitely). 

C. Capital Costs 

As discussed in the final rule, a small 

number of carton-enclosed products 

may require new packaging to 

accommodate longer inserts. As many as 

5 percent of the existing products 

affected by the final rule (i.e., products 

with new efficacy supplements, 

products approved in the 5 years prior 

to the effective date of the rule, and 

affected abbreviated new drug 

applications) may require equipment 

changes at an estimated cost of $200,000 

each product. 

In the Federal Register of September 

29, 2008 (73 FR 56592), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

relating to the paperwork. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR NEW DRUG APPLICATIONS1

Category (21 CFR Section) No. of Respondents No. of Responses per 

Respondent 

Total 

Responses 

Hours per 

Response Total Hours 

Annual Burden for Labeling Requirements in §§ 201.56 and 201.57 85 1.26 107 3,349 358,343 

Total 358,343 

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

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG

PRODUCTS1

Category (21 CFR Section) No. of Respondents No. of Responses per 

Respondent 

Total 

Responses 

Hours per 

Response Total Hours 

Burden associated with revised labeling for applications approved within 

5 years prior to June 30, 2006 

(§ 201.57) 172 2 344 196 67,424 

Burden associated with revised labeling for efficacy supplements submitted on or after June 30, 2006 

(§§ 201.56(d) and 201.57) 172 1.08 186 196 36,456 

Burden associated with revised labeling for efficacy supplements for generic drug products (§ 201.57) 42 8 336 27 9,072 

Total 112,952 

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

Dated: December 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–175 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0657] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Recommendations 

for the Early Food Safety Evaluation of 

New Non-Pesticidal Proteins Produced 

by New Plant Varieties Intended for 

Food Use 

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 

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Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 907 

the information collection provisions of 

the guidance document entitled 

‘‘Recommendations for the Early Food 

Safety Evaluation of New Non-Pesticidal 

Proteins Produced by New Plant 

Varieties Intended for Food Use.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by March 10, 2009. 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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) 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. 

Recommendations for the Early Food 

Safety Evaluation of New NonPesticidal Proteins Produced by New 

Plant Varieties Intended for Food Use 

(OMB Control Number 0910–0583— 

Extension) 

Since May 29, 1992, when FDA 

issued a policy statement on foods 

derived from new plant varieties, FDA 

has encouraged developers of new plant 

varieties, including those varieties that 

are developed through biotechnology, to 

consult with FDA early in the 

development process to discuss possible 

scientific and regulatory issues that 

might arise (57 FR 22984). The guidance 

entitled ‘‘Recommendations for the 

Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by 

New Plant Varieties Intended for Food 

Use’’ continues to foster early 

communication by encouraging 

developers to submit to FDA their 

evaluation of the food safety of their 

new protein. Such communication 

helps to ensure that any potential food 

safety issues regarding a new protein in 

a new plant variety are resolved early in 

development, prior to any possible 

inadvertent introduction into the food 

supply of material from that plant 

variety. 

FDA believes that any food safety 

concern related to such material 

entering the food supply would be 

limited to the potential that a new 

protein in food from the plant variety 

could cause an allergic reaction in 

susceptible individuals or could be a 

toxin. The guidance describes the 

procedures for early food safety 

evaluation of new proteins in new plant 

varieties, including bioengineered food 

plants, and the procedures for 

communicating with FDA about the 

safety evaluation. 

The respondents to this collection of 

information are developers of new plant 

varieties intended for food use. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

First four data components 20 1 20 4 80 

Two other data components 20 1 20 16 320 

Total 400 

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

FDA estimates the annual total hour 

burden for this collection of information 

to be 400 hours. This estimate is based 

on early food safety evaluations 

submitted in the past 3 years. FDA’s 

estimate of the time that it would take 

a respondent to prepare the data 

components of the early food safety 

evaluation submission is based on the 

agency’s experience with similar 

submissions. 

Completing an early food safety 

evaluation for a new protein from a new 

plant variety is a one-time burden (one 

evaluation per new protein). Based on 

its experience over the past 3 years, 

FDA estimates that approximately 20 

developers will choose to complete an 

early food safety evaluation for their 

new plant protein. Many developers of 

novel plants may choose not to submit 

an evaluation because the field testing 

of a plant containing a new protein is 

conducted in such a way (e.g., on such 

a small scale, or in such isolated 

conditions, etc.) that cross-pollination 

with traditional crops or commingling 

of plant material is not likely to be an 

issue. Also, other developers may have 

previously communicated with FDA 

about the food safety of a new plant 

protein, for example, when the same 

protein was expressed in a different 

crop. 

The early food safety evaluation for 

new proteins includes six main data 

components. Four of these data 

components are easily and quickly 

obtainable, having to do with the 

identity and source of the protein. FDA 

estimates that completing these data 

components will take about 4 hours per 

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908 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

evaluation. In table 1 of this document, 

row 1 shows that for 20 evaluations, the 

total burden for these 4 data 

components is 80 hours. 

Two data components ask for original 

data to be generated. One data 

component consists of a bioinformatics 

analysis which can be performed using 

publicly available databases. The other 

data component involves ‘‘wet’’ lab 

work to assess the new protein’s 

stability and the resistance of the 

protein to enzymatic degradation using 

appropriate in vitro assays (protein 

digestibility study). The paperwork 

burden of these two data components 

consists of the time it takes the company 

to assemble the information on these 

two data components to submit to FDA. 

We estimate that these two data 

components will take 16 hours to 

complete (8 hours for each component). 

In table 1 of this document, row 2 shows 

that for 20 evaluations, the total burden 

for these two data components is 320 

hours. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: December 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–213 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0081] (formerly 

Docket No. 2006D–0297) 

International Conference on 

Harmonisation; Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex on 

Test for Extractable Volume of 

Parenteral Preparations General 

Chapter; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 2: Test for 

Extractable Volume of Parenteral 

Preparations General Chapter.’’ The 

guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance provides the results of the 

ICH Q4B evaluation of the Test for 

Extractable Volume of Parenteral 

Preparations General Chapter 

harmonized text from each of the three 

pharmacopoeias (United States, 

European, and Japanese) represented by 

the Pharmacopoeial Discussion Group 

(PDG). The guidance conveys 

recognition of the three pharmacopoeial 

methods by the three ICH regulatory 

regions and provides specific 

information regarding the recognition. 

The guidance is intended to recognize 

the interchangeability between the local 

regional pharmacopoeias, thus avoiding 

redundant testing in favor of a common 

testing strategy in each regulatory 

region. In the Federal Register of 

February 21, 2008 (73 FR 9575), FDA 

made available a guidance on the Q4B 

process entitled ‘‘Q4B Evaluation and 

Recommendation of Pharmacopoeial 

Texts for Use in the ICH Regions.’’ 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002; or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. Send two selfaddressed adhesive labels to assist the 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242; or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–1), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

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