11550 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

panel to have 2,700 of them complete a 

15-minute (0.25 hours) questionnaire. 

The total for the survey activities is 855 

hours (180 hours + 675 hours). 

Therefore, the total estimated burden is 

1,052 hours. This estimate is 454 hours 

lower than the 1,506 hours described in 

the 60-day notice and reflects 15 fewer 

hours for pretest invitation, 533 fewer 

hours for survey invitation, and 94 more 

hours for the pretest, respectively. 

Recent experience by our contractor 

suggests that the Agency will not need 

to send as many invitations as originally 

estimated to achieve its target sample 

sizes in pretest and survey. FDA’s 

burden estimate is based on prior 

experience with research that is similar 

to this proposed study. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Cognitive interview screener .... 72 1 72 0.083 (5 minutes) ..................... 6 

Cognitive interview ................... 9 1 9 1 hour ....................................... 9 

Pretest invitation ....................... 1,152 1 1,152 0.033 (2 minutes) ..................... 38 

Pretest ...................................... 576 1 576 0.25 (15 minutes) ..................... 144 

Survey invitation ....................... 5,400 1 5,400 0.033 (2 minutes) ..................... 180 

Survey ....................................... 2,700 1 2,700 0.25 (15 minutes) ..................... 675 

Total ................................... ............................ ............................ ............................ ................................................... 1,052 

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

II. References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20857, under 

Docket No. FDA–2011–N–0320 and may 

be seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday. We have verified all Web site 

addresses, but we are not responsible for 

any subsequent changes to the Web sites 

after this document publishes in the 

Federal Register. 

1. U.S. Food and Drug Administration, 

‘‘Claims That Can Be Made for Conventional 

Foods and Dietary Supplements,’’ September 

2003, available at http://www.fda.gov/Food/

LabelingNutrition/LabelClaims/

ucm111447.htm. 

2. Cleveland, L.E., A.J. Moshfegh, A.M. 

Albertson, et al., ‘‘Dietary Intake of Whole 

Grains,’’ Journal of the American College of 

Nutrition, vol. 19, pp. 331S–338S, 2000. 

3. Kantor, L.S., J.N. Variyam, J.E. 

Allshouse, et al., ‘‘Choose a Variety of Grains 

Daily, Especially Whole Grains: A Challenge 

for Consumers,’’ Journal of Nutrition, vol. 

131, pp. 473S–486S, 2001. 

4. U.S. Department of Agriculture and U.S. 

Department of Health and Human Services, 

‘‘Executive Summary of Dietary Guidelines 

for Americans, 2010,’’ January 2011, 

available at http://www.cnpp.usda.gov/

Publications/DietaryGuidelines/2010/

PolicyDoc/ExecSumm.pdf. 

5. Supermarket News, ‘‘Report: Whole 

Grains Gain Momentum,’’ September 17, 

2010, available at http://supermarketnews.

com/news/whole_grains_0917/#. 

6. Arvola, A., L. La ̈hteenma ̈ki, M. Dean, et 

al., ‘‘Consumers’ Beliefs About Whole and 

Refined Grain Products in the UK, Italy and 

Finland,’’ Journal of Cereal Science, vol. 46, 

pp. 197–206, 2007. 

7. Kantor, L.S., J.N. Variyam, J.E. 

Allshouse, et al., ‘‘Choose a Variety of Grains 

Daily, Especially Whole Grains: A Challenge 

for Consumers,’’ Journal of Nutrition, vol. 

131, pp. 473S–486S, 2001. 

8. Marquart, L., K.L. Wiemer, J.M. Jones, et 

al., ‘‘Whole Grain Health Claims in the USA 

and Other Efforts to Increase Whole-Grain 

Consumption,’’ Proceedings of the Nutrition 

Society, vol. 62, pp. 151–160, 2003. 

9. Drichoutis, A.C., P. Lazaridis, and R.M. 

Nayga, ‘‘Consumers’ Use of Nutritional 

Labels: A Review of Research Studies and 

Issues,’’ Academy of Marketing Science 

Review, vol. 10.9, 2006. 

10. Grunert, K.G. and J.M. Willis, ‘‘A 

Review of European Research on Consumer 

Response to Nutrition Information on Food 

Labels,’’ Journal of Public Health, vol. 15, 

pp. 384–399, 2007. 

11. Kellogg Company. ‘‘A Survey of 

Consumers’ Whole Grain & Fiber 

Consumption Behaviors, and the Perception 

of Whole Grain Foods as a Source of Dietary 

Fiber,’’ 2010. FDA Docket No. 2006–D–0298. 

July 2010, available at http://

www.regulations.gov/#!document

Detail;D=FDA–2006–D–0298–0016. 

12. Clark, L.A. and D. Watson, 

‘‘Constructing Validity: Basic Issues in 

Objective Scale Development,’’ Psychological 

Assessment, vol. 7(3), pp. 309–319, 1995. 

Dated: February 21, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4423 Filed 2–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0140] 

Draft Guidance for Industry on 

Notification to Food and Drug 

Administration of Issues That May 

Result in a Prescription Drug 

Shortage; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Notification to FDA 

of Issues that May Result in a 

Prescription Drug or Biological Product 

Shortage.’’ This draft guidance relates to 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), which requires sole 

manufacturers to notify FDA of a 

discontinuance of certain drug products 

and to the President’s Executive Order 

13588 of October 31, 2011, directing 

FDA to use all available administrative 

tools to expand the Agency’s efforts to 

combat the problem of drug shortages. 

We are also requesting responsive 

comments from interested stakeholders 

on a specific question posed in this 

Federal Register document related to 

the draft guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 29, 2012. 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11551 

Submit either electronic or written 

comments concerning the proposed 

collection of information by April 27, 

2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research (CDER), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 51, rm. 

2201, Silver Spring, MD 20993–0002 or 

to the Office of Communication, 

Outreach and Development (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist the office in processing your 

request. The guidance may also be 

obtained by mail by calling CDER at 

301–796–3400 or CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments on the draft guidance 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kalah Auchincloss, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6208, 

Silver Spring, MD 20993, 301–796– 

0659; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 Rockville 

Pike, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is concerned about the rising 

incidence of drug shortages in the 

United States, particularly those 

involving drugs that are manufactured 

by a small number of firms and for 

which no good therapeutic substitutes 

are available. The number of drug 

shortages has been rising steadily over 

the last 5 years, tripling from 61 in 2005 

to 178 in 2010. In 2011, FDA tracked 

over 250 drug shortages. Some of these 

shortages delay or deny needed care for 

patients since they involve critical drugs 

used to treat cancer, to fight infectious 

diseases, to provide required nutrition, 

or to address other serious medical 

conditions. Other shortages force 

providers to prescribe second-line 

alternatives, which can be less effective 

and higher risk than first-line therapies. 

Under section 506C of the FD&C Act 

(21 U.S.C. 356c), sole manufacturers are 

required to report to FDA 

discontinuances of drug products that 

are life-supporting, life-sustaining, or 

intended for use in the prevention of a 

debilitating disease or condition and 

that are approved under a new drug 

application (NDA) or abbreviated new 

drug application (ANDA). On October 

31, 2011, FDA sent a letter to 

manufacturers reminding them of their 

mandatory reporting requirements 

under section 506C of the FD&C Act and 

encouraging them to voluntarily notify 

the Agency of potential disruptions to 

supply of a prescription product that 

could lead to a product shortage, even 

beyond those instances that are required 

to be reported by statute. On the same 

day, the President issued Executive 

Order 13588 directing FDA to use all 

available administrative tools to expand 

its efforts to combat the problem of drug 

shortages. 

FDA recognizes that some shortages 

can be neither predicted nor prevented; 

however, we know that effective 

communication and early notification 

from manufacturers has a significant 

impact on the incidence and duration of 

shortages. Manufacturers can play a 

critical role in decreasing the impact of 

shortages by reporting to the FDA 

circumstances that might affect their 

ability to supply the market and 

potentially lead to a product shortage. 

Notifying FDA in advance of incidents 

that may result in a shortage helps FDA 

work with manufacturers to take early 

action to prevent or alleviate shortages. 

For example, in 2011, early notification 

by manufacturers allowed FDA to help 

prevent shortages of 195 drugs, 

including 86 drugs produced by one 

company. However, as the President 

recognized in the Executive Order, FDA 

cannot begin to work with 

manufacturers or use tools at our 

disposal to avoid or mitigate a shortage 

until we know there is a potential 

problem. 

There is no single, or simple, solution 

that can resolve the drug shortage 

problem, but we are committed to 

working with manufacturers, 

distributors, health care providers, and 

other stakeholders to identify the issues 

that can lead to shortages, to establish 

processes to avoid or mitigate critical 

shortages in the future, and to ensure 

continued patient access to vital safe 

and effective products. As part of this 

effort, we are issuing this guidance to 

help manufacturers better understand 

mandatory reporting obligations, to 

encourage voluntary reporting of 

additional issues that could lead to a 

shortage or disruption in supply of a 

drug or biological product, and to 

address other issues, such as quality 

control and contingency planning 

related to product shortages or potential 

disruption in supply. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on required and voluntary notifications 

to FDA of issues related to product 

shortages. 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. Request for Information 

To assist us in finalizing guidance on 

drug shortages, FDA is seeking 

information and comments on the draft 

guidance from interested stakeholders. 

Although we welcome comment on any 

aspect of the draft guidance, we are 

particularly interested in obtaining 

information and comment regarding the 

appropriate scope of voluntary reporting 

of disruptions that may lead to a 

product shortage or potential disruption 

in supply. Specifically, please comment 

on whether manufacturers of all 

prescription drug and biological 

products should be encouraged to notify 

FDA of issues that may lead to a product 

shortage or potential disruption in 

supply. In your comments, please 

indicate whether the Agency should 

encourage voluntary reporting with 

regard to only a certain subset of 

prescription drug and biological 

products and, if so, please describe the 

products. 

The comment period for the related 

interim final rule (IFR) on drug 

shortages published in the Federal 

Register of December 19, 2011 (76 FR 

78530), and effective January 18, 2012, 

closed on February 17, 2012. Please do 

not submit comments on the IFR to the 

docket for the draft guidance; we will 

not consider comments on the IFR 

submitted to the docket for the draft 

guidance. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 that 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 


srobinson on DSK4SPTVN1PROD with NOTICES
11552 Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 

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 for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comments on the 

following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

The draft guidance provides 

information on the requirements for 

notification to FDA of a discontinuance 

of certain drug products under section 

506C of the FD&C Act as implemented 

by 21 CFR 314.81(b)(3)(iii) and 314.91, 

and also reflects amendments to the 

implementing regulations published in 

the Federal Register as an IFR on 

December 19, 2011 and effective January 

18, 2012. The draft guidance also 

provides information to industry on 

voluntarily notifying FDA of other 

issues that may result in a shortage or 

disruption in supply of a prescription 

drug or biological product in the U.S. 

market. In addition, the draft guidance 

encourages manufacturers to make 

contingency plans for responding to 

situations that could lead to a drug or 

biological product shortage or potential 

disruption in supply. The draft 

guidance is intended for manufacturers 

of prescription drug and biological 

products regulated by CDER or CBER. 

The burden analysis for the 

information collection resulting from 

the mandatory notification requirements 

under section 506C of the FD&C Act, as 

implemented by §§ 314.81(b)(3)(iii) and 

314.91, and from the implementing 

regulations in the December 19, 2011, 

IFR, was submitted to OMB for 

emergency review under the PRA on 

December 21, 2011 (see ‘‘V. Paperwork 

Reduction Act of 1995’’ at 76 FR 78537). 

OMB has approved this information 

collection under OMB control number 

0910–0699. A discussion of the scope 

and logistics of mandatory notification 

under section 506C of the FD&C Act and 

the IFR is found in section III of the 

draft guidance. 

Under section IV of the draft 

guidance, manufacturers of all 

prescription drug and biological 

products are encouraged to voluntarily 

notify FDA of issues that may result in 

a shortage of a product in the U.S. 

market or a potential disruption in 

supply. Voluntary notification of issues 

that may lead to a potential shortage or 

disruption in supply includes reporting 

of circumstances beyond those instances 

that are required to be reported by 

section 506C, and includes the 

following: 

• Product quality problems, such as 

the presence of particulates or 

impurities, microbial contamination, 

and stability concerns; 

• Interruptions or other adjustments 

in manufacturing that may adversely 

affect market supply, such as routine 

maintenance, that may temporarily halt 

production or renovation of 

manufacturing facilities; 

• Delays in acquiring critical raw 

materials or components, or loss of raw 

material or components supplier (e.g. 

vials, stoppers, bottles); 

• Transfer of manufacturing to an 

alternate facility (e.g. due to loss of an 

existing manufacturing site or to add 

additional capacity); 

• Loss of a production line or 

production capacity (e.g., machinery 

failure or malfunction or quality issues 

related to a cell line); 

• Any production problems that 

occur during or after manufacturing that 

could result in supply disruptions (e.g. 

out of specification test results, stability 

problems, or labeling and packaging 

defects); 

• Import delays (e.g. shipments 

detained upon entry to the United States 

for any reason that may delay delivery 

to the manufacturing firm); 

• Unexpected increases in demand 

(e.g. due to a shortage of an alternative 

product); and 

• Product discontinuances (e.g. a 

business decision to stop manufacturing 

or marketing the product or a temporary 

product hold while investigating issues 

that may result in a recall), even if you 

are not a sole manufacturer or the 

product in question is not subject to 

section 506C. 

Based on the number of shortages we 

have seen during the past 12 months, 

we estimate that annually a total of 

approximately 480 manufacturers 

(‘‘number of respondents’’ in table 1 of 

this document) will voluntarily notify 

us of issues that may result in a shortage 

or potential disruption in supply of a 

drug or biological product, as described 

previously. We estimate that these 

manufacturers will submit annually a 

total of approximately 480 notifications 

(‘‘total annual responses’’ in table 1 of 

this document). We also estimate that 

preparing and submitting this 

information to us will take 

approximately 2 hours per manufacturer 

(‘‘hours per response’’ in table 1 of this 

document), including the time that 

some manufacturers may need to 

prepare information and take remedial 

steps in response to follow up questions 

and other action from FDA, as described 

in section V of the draft guidance. We 

base this estimate on our experience 

with the reporting of similar 

information to FDA, including 

mandatory reporting under section 506C 

of the FD&C Act of discontinuance of 

manufacturing of a sole source drug that 

is life-supporting, life-sustaining, or 

intended for use in the prevention of a 

serious disease or condition, and from 

the increase in voluntary notifications 

received since publication on October 

31, 2011, of the letter to manufacturers 

requesting such reports. 

Under section VI of the draft 

guidance, manufacturers are encouraged 

to engage in quality control, riskmanagement, and contingency planning 

for responding to situations that could 

lead to a drug or biological product 

shortage or potential disruption in 

supply. The draft guidance explains that 

contingency plans should cover 

additional manufacturing sites, 

production lines, and suppliers, such as 

building redundancy into 

manufacturing capabilities or providing 

for additional suppliers under the NDA, 

ANDA, and BLA processes. The plans 

may need to identify alternative API and 

component suppliers and/or have 

redundant manufacturing capacity 

registered and in compliance with 

current good manufacturing practices 

under 21 CFR parts 210 and 211. 

In table 2 of this document, we 

estimate that a total of approximately 70 

manufacturers (‘‘number of 

recordkeepers’’ in table 2 of this 

document) will prepare contingency 

plans for responding to situations that 

could lead to a product shortage or 

potential disruption in supply, as 

described above. We estimate that these 

manufacturers will prepare a total of 

approximately 70 contingency plans 

(‘‘total records’’ in table 2 of this 

document). We also estimate that 

preparing and maintaining each 

contingency plan will take 

approximately 500 hours per 

manufacturer (‘‘average burden per 

recordkeeping’’ in table 2 of this 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 38 / Monday, February 27, 2012 / Notices 11553 

document). We base this estimate on our 

experience with related contingency 

planning under the draft guidance for 

industry entitled: ‘‘Planning for the 

Effects of High Absenteeism to Ensure 

Availability of Medically Necessary 

Drug Products’’ (Absenteeism Draft 

Guidance) published in the Federal 

Register of January 8, 2010 (75 FR 

1060), and October 18, 2010 (75 FR 

63832), and the public comments we 

received on our burden estimate for that 

guidance. The Absenteeism Draft 

Guidance recommends that drug and 

biological product manufacturers 

develop written plans to maintain an 

adequate supply of medically necessary 

products during an emergency that 

results in high employee absenteeism. 

Although the draft guidance that is the 

subject of this Federal Register 

document is not related to employee 

absenteeism, the two guidance 

documents apply to a similar group of 

manufacturers and we believe the 

contingency plans recommended in 

both draft guidance documents will 

include similar elements. Accordingly, 

we believe the burden estimates from 

the Absenteeism Draft are relevant to 

this draft guidance. However, we 

specifically request comment on these 

contingency plan burden hour 

estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED REPORTING BURDEN 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Hours per 

response Total hours 

Voluntary Reporting Under Section IV of the Draft Guidance .................................................................................. 480 1 480 2 960 

Total .............................................................................. ........................ ........................ ........................ ........................ 960 

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

TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

records 

Average 

burden per 

recordkeeping 

(in hours) 

Total hours 

Voluntary Contingency Plans Under Section VI of the Draft 

Guidance .......................................................................... 70 1 70 500 35,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 35,000 

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

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either written or electronic 

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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/ucm121568.htm, http:// 

www.fda.gov/cber/guidelines.htm, or 

http://www.regulations.gov. 

Dated: February 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–4439 Filed 2–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0080] 

Draft Guidance on Food and Drug 

Administration Oversight of Positron 

Emission Tomography Drug 

Products—Questions and Answers; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘FDA Oversight of PET Drug Products— 

Questions and Answers.’’ The draft 

guidance provides questions and 

answers that address nearly all aspects 

of the FDA approval and surveillance 

processes, including application 

submission, review, compliance with 

good manufacturing practices, 

inspections, registration and listing, and 

user fees. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 29, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft guidance document. 

Submit electronic comments on the 

draft 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: 

Elizabeth Giaquinto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave. Bldg. 51, rm. 6164, 


srobinson on DSK4SPTVN1PROD with NOTICES