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register. Therefore, FDA estimates that zero vending machine operators will register with FDA under section 4205 of the Affordable Care Act.

According to The NPD Group’s Spring 2010 ReCount report, there were 579,416 sole purpose eating and drinking establishments in the United States in the winter of 2010 (Ref. 2). Of these, 40 percent will be explicitly subject to FDA rulemaking for the Affordable Care Act because they are part of chains with 20 or more outlets (Ref. 2). Of the remaining 350,000 outlets, only those that would be subject to local or State rules concerning menu labeling would have any incentive to register. Approximately 7.5 percent of restaurant outlets are in States or localities with currently operational menu labeling regulation, principally New York City, Oregon, Philadelphia, and some New York State counties (Ref.

3). NPD’s Spring 2010 ReCount report shows a total of 20,000 outlets are part of chains with between 10 and 19 establishments. If outlets are evenly distributed geographically, then 1,500 outlets and 103 restaurant firms may have an incentive to register with FDA.

The hourly burden for restaurant chains is 206 hours (=100 chains × 1 responses/ chain/year × 2 hours/response).

From the U.S. Census County Business Patterns data, FDA estimates that there are approximately 62,000 grocery stores in 2010. Of these, approximately 6,500 are independents ‘‘’’

which means that they are part of chains with fewer than 11 outlets (Ref. 4), and 35,000 are known to belong to chains with more than 20 outlets (Ref. 5). We round the remaining 20,523 outlets up to 21,000 to account for those outlets in chains with 10 or 11 establishments.

County Business Patterns show that 11.5 percent of all grocery stores are in jurisdictions that have relevant menu labeling regulations. Taking 11.5 percent of 21,000 yields approximately 2,400 stores run by 167 firms. The hourly burden for grocery chains is 334 hours (= 167 chains × 1 responses/ chain/year × 2 hours/response).

According to Stagnito Media, there are 144,000 convenience store outlets in the United States (Ref. 6). Of these, 64,000 are defined as very small ‘‘ mom and poplocations. Approximately ’’

FDA estimates that approximately 160 to the Web sites after this document convenience store outlets from 11 firms publishes in the Federal Register.) may have an incentive to register under 1. Food and Drug Administration. 2003.

this notice. The hourly burden for ‘‘Registration of Food Facilities Under the convenience store chains is 22 hours Public Health Security and Bioterrorism (=11 chains 1 responses/chain/year Preparedness and Response Act of 2002, ’’ × × 68 2 hours/response). FR 5378, February 3, 2003.

2. The NPD Group, Chains System Size ‘‘ Additional covered establishments, Trend Report for U.S. FDA, ’’ ReCount, Spring such as those operating in lodging, 2010.

corporate, entertainment, and 3. U.S. Census Bureau, 2007, County educational settings are often provided Business Patterns, http://www.census.gov/ by very large firms with many hundreds econ/cbp/index.html, 2007, version date or thousands of outlets, and will thus be September 22, 2009.

4. Moran, M., J. McTaggart, and D. Chanil, explicitly covered by section 4205 of the Looking Up, Cautiously, ‘‘’’ Progressive Grocer Affordable Care Act rather than by the 89(3): 20–52, 2010.

registration provisions. FDA estimates 5. Food Marketing Institute, Top U.S.

that an additional 81 firms, controlling Supermarket & Grocery Chains (by 2007 approximately 1,200 outlets may have grocery sales), http://www.fmi.org, 2008.

an incentive to register. The hourly 6. Stagnito Media, ‘‘Directory of burden for these additional chains is Convenience Stores: FAQ,’’ http:// 162 hours (= 81 chains × 1 responses/ www.conveniencestores.com/faq.html, accessed June 1, 2010.

chain/year × 2 hours/response).

‘‘Convenience Store News: Hot 7. Longo, D.

If all of these restaurant and similar , 45(10), ’’ Convenience Store News Top 100 retail food establishment chains choose pp. 27–32, August 10, 2009.

to register with FDA, then FDA Dated: January 25, 2011.

estimates the number of firms Leslie Kux, registering in the first year would be approximately 362 firms. At 2 hours per Acting Assistant Commissioner for Policy.

FDA estimates that the rate of growth DEPARTMENT OF HEALTH AND for chains entering the 10 to 19 outlet HUMAN SERVICES segment will match the rate of growth out of this segment, so that the number Food and Drug Administration of registrants will remain constant.

County Business Patterns data shows an [Docket No. FDA–2001–D–0254; formerly average growth rate in the number of Docket No. 2001D–0037] establishments to be 2 percent per year Draft Guidance for Industry: Pre over the 8 years from 1999 to 2007 for Storage Leukocyte Reduction of Whole restaurants (Ref. 3). If the restaurant Blood and Blood Components growth rate for outlets of approximately Intended for Transfusion; Availability 2 percent per year applies to these chains, then new registrants will AGENCY: Food and Drug Administration, amount to approximately 7 per year, HHS.

with the remaining 355 registrants only ACTION: Notice.

renewing their registration. The yearly burden for registration is estimated to be SUMMARY: The Food and Drug 1 hour per new registrant. Thus, the Administration (FDA) is announcing the total hour burden will be 7 hours (7 availability of a draft document entitled Guidance for Industry: Pre-Storage ‘‘ firms × 1 hour/firm). The yearly burden for renewing registration is estimated to Leukocyte Reduction of Whole Blood be 0.25 hour per continuing registrant. and Blood Components Intended for Thus, the total hour burden will be 89 Transfusion’’ dated January 2011. The hours (355 firms × 0.25 hour/firm = draft guidance document provides blood 88.75, rounded to 89). This yields a establishments with recommendations recurring hourly burden of 96 hours per for pre-storage leukocyte reduction of year (7 hours + 89 hours). Whole Blood and blood components intended for transfusion, including II. References recommendations for validation and The following references have been quality control monitoring of the placed on display in the Division of leukocyte reduction process. This Dockets Management (see ADDRESSES), second draft guidance document and may be seen by interested persons incorporates revisions after reviewing between 9 a.m. and 4 p.m., Monday comments on the January 2001 draft.

through Friday. (FDA has verified the This draft guidance replaces the draft Web site addresses, but we are not guidance of the same title dated January responsible for any subsequent changes 2001. This draft guidance, when

Federal Register

finalized, will supersede the FDA memorandum issued on May 29, 1996, entitled ‘‘Recommendations and Licensure Requirements for Leukocyte Reduced Blood Products.’’ 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 2, 2011.

ADDRESSES: Submit written requests for single copies of the draft guidance 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 requests.

The draft guidance may also be obtained by mail by calling 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 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: Lori Jo Churchyard, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background FDA is announcing the availability of a revised, second draft document entitled ‘‘Guidance for Industry: Pre Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion’’ dated January 2011.

additional public discussions held at the June and December 2001 meetings of the Blood Products Advisory Committee and the July 2005 public workshop entitled ‘‘Update on Leukocyte Reduction of Blood and Blood This draft guidance ’’ Components.

replaces the draft guidance of the same title dated January 2001 (January 31, 2001, 66 FR 8410). The draft guidance, when finalized, will supersede the FDA memorandum issued on May 29, 1996, entitled ‘‘Recommendations and Licensure Requirements for Leukocyte Reduced Blood Products.’’ The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115).

The draft guidance, when finalized, will represent FDA’s current thinking on this topic. 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 requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
