Comment on Proposed Regulations and Submit Petitions: FDA

March 8, 2011

As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices–commodities close to the daily lives of all Americans.

By law, anyone can participate in the rule-making process by commenting in writing on rules FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule.

FDA gathers public comments mainly through 2 channels: proposed rules and petitions.

Proposed Rules

When FDA plans to issue a new regulation or revise an existing one, it places an announcement in the Federal Register on the day the public comment period begins. Published every weekday, the Federal Register is available at many public libraries and colleges, and on the FDA Web site. Issues open to public comment often are reported by the news media and can also be found at regulations.gov. Instructions for finding Federal Register documents and submitting comments are found on  the Federal Dockets Management System Instruction Sheet.

Also noted is the “comment period,” which specifies how long the agency will accept public comments. Usually, the file–or docket–stays open for comments at least 60 days, though some comment periods have been as short as 10 days or as long as nine months. Weekends and holidays are included in the comment period.

Comment Online

The Federal Dockets Management System Instruction Sheet tells how to submit comments electronically at regulations.gov.

Petitions

Another way to influence the way FDA does business is to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly.

Petitions require careful preparation by the submitter. FDA spends considerable time and staff resources processing petitions. Individuals sometimes submit petitions, but most come from regulated industry or consumer groups.

Source: http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm

Advertisements

iPad2 by Apple

March 3, 2011

The iPad 2, which like its predecessors starts at $499, will ship in the U.S. on March 11 and in 26 more countries on March 25.

iPad2 features

It comes with front and rear cameras—addressing an omission in the initial model—and a new Apple-designed chip that performs standard calculations twice as fast as its predecessor and offers a nine-fold boost in graphics performance.

Apple had reinforced its edge with the sheer volume of new features, its lead in applications created for the iPad and its lower price point than some rivals; Xoom, for example, starts at $799 without a cellular service plan, compared with $729 for a comparable iPad.

  • Dual-core A5 processor
  • Upto 2X faster processing, 9X faster graphics
  • Dual video cameras
  • 33% thinner the original
  • 1.3 pounds
  • Comes in white and black
  • Both CDMA and GSM
  • 10 hour battery life
  • Same price points as the previous iPad – starts at $499
  • 65,000 apps
  • HDMI Video out (using $39 connector)
  • New retractable case ($39, $9 for leather) includes microfiber for cleaning, wake on open-sleep on close
  • Personal hotspot for iPhone4 only
  • Photo Booth, Face Time, Garage Band and iMovi

Source


Budget 2011 +ve

March 1, 2011
Positive Outcome 

  1. Current surcharge of 7.5 per cent on domestic companies proposed to be reduced to 5 per cent
  2. Higher exemption limit of Rs 5,00,000 for very senior citizens, who are 80 years or above
  3. Allocation to Sarva Shiksha Abhiyan increase by 40 per cent to Rs 21,000 crore
  4. Allocation for education increased by 24 per cent over current year
  5. Allocation of Rs 2,14,000 crore for infrastructure in 2011-12; an increase of 23.3 per cent over 2010-11
  6. Excise duty to be reduced from 10% to 5% on parts of specified machinery
  7. Surcharge for companies cut to 5 per cent, from 7.5 per cent
  8. Special incentives for hybrid vehicle makers if manufacturing done in India to be positive for auto companies
  9. Crude palm used in sports exempted from customs duty to be positive for palm oil companies
  10. Duty reduced on hybrid & electric cars along with batteries imported for such vehicles
  11. Senior Citizen Age Limit reduced from 65 years to 60 years for Income Tax purposes
  12. Naina Lal Kidwai: The green orientation of the budget is a welcome positive
  13. Basic customs duty on agricultural machinery reduced to 4.5 per cent from 5 per cent
  14. No import duty on ship parts positive for SCI
  15. Tax exemption limit for senior citizens raised to Rs 2.5 lakh from 2.4 lakh

Source- http://economictimes.indiatimes.com/budget.cms